Laboratory Focus November/December 2015

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R&D News.......................... 1 Appointments..................... 6 Pharma Notes..................... 7 New Products................... 15 App Reviews...................... 18 Calendar........................... 19

Queen’s professor emeritus named co-winner of Nobel Prize in physics Queen’s University Professor Emeritus Dr. Arthur B. McDonald is the co-winner of the 2015 Nobel Prize in physics for his research into neutrinos, one of the fundamental particles that make up the universe.

The announcement made by the Royal Swedish Academy of Sciences in Stockholm, said Dr. McDonald won the award, along with Takaaki Kajita of the University of Tokyo, “for their key contributions to the experiments which demonstrated that neutrinos change identities.” Their findings solved a puzzle that physicists had wrestled with for decades, the academy added.

“I am truly honoured to receive the Nobel Prize in physics,” Dr. McDonald said in response to winning the prestigious prize. “While I am a co-winner of the Nobel Prize, the honour really represents a culmination of the hard work and contributions of Canadian and international colleagues with whom I have collaborated with during my career.”

In 1989, Dr. McDonald joined Queen’s University as a professor of physics and director of the Sud-

bury Neutrino Observatory (SNO), now known as SNOLAB, located in Vale’s Creighton mine near Sudbury, ON. Working in the world’s deepest underground laboratory, the SNOLAB team discovered that neutrinos – sub-atomic particles considered the basic building blocks of the universe – change from one type to another on their journey to Earth from the sun.

This finding confirmed that these fundamental particles have a finite mass and that the current models for energy generation in the sun are very accurate.

Dr. McDonald continues to conduct research in the field of particle astrophysics, leading further analysis of the data from all phases of the SNO experiment and participating in the DEAP and SNO+ experiments. Dr. McDonald and his colleagues also continue to work on cutting-edge research in areas of theoretical, computational, applied and experimental physics.

For his research, Dr. McDonald has received a number of awards and recognitions including being elected a Fellow of Queen’s University Professor Emeritus Dr. Arthur B. McDonald

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the Royal Society of the UK and Commonwealth in 2009. In 2010 he received the Killam Prize in the Natural Sciences, in 2011 he received the Henry Marshall Tory Medal from the Royal Society of Canada, its highest award for scientific achievement; and in 2013

he was awarded the European Physics Society HEP Division Giuseppe and Vanna Cocconi Prize for Particle Astrophysics.

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Chemists design rapid, simple, inexpensive tests using DNA

PUBLISHER/EDITOR-IN-CHIEF Terri Pavelic

Chemists at the University of Montréal are using DNA molecules to develop rapid, inexpensive medical diagnostic tests that take only a few

CONTRIBUTING WRITER Jenny Boon Michael Klein

minutes to perform. Their findings, published in the Journal of the American Chemical Society, may aid efforts to build point-of-care devices for quick medical diagnosis of various diseases ranging from cancer, allergies, autoimmune

diseases, sexually transmitted diseases (STDs), and many others.

The new technology may also drastically impact global health, due to its potential low cost and easiness of use, according to the research

team. The diagnostic tests are made of DNA and use one of the simplest forces in chemistry, steric effects – a repulsion force that arises when atoms are brought too

Continued on page 3

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Continued from page 2 close together – to detect a wide array of protein markers that are linked to various diseases. The design was created by the research group of Alexis Vallée-Bélisle, a professor in the Department of Chemistry at University of Montréal.

“Despite the power of current diagnostic tests, a significant limitation is that they still require complex laboratory procedures (and) patients typically must wait for days or even weeks to receive the results of their blood tests,” Vallée-Bélisle said. “If we can move testing to the point of care, or even at home, it would eliminate the lag time between testing and treatment, which would enhance the effectiveness of medical interventions.”

The key breakthrough underlying this new technology came by chance.

“While working on the first generation of these DNA-base tests, we realized that proteins, despite their small

size (typically 1,000 times smaller than a human hair) are big enough to run into each other and create steric effect (or traffic) at the surface of a sensor, which drastically reduced the signal of our tests,” said Sahar Mahshid, post-

OICR, UHN, Novera Therapeutics team with Johnson & Johnson Innovation

The Ontario Institute for Cancer Research together with Novera Therapeutics Inc. (Novera) are collaborating with Janssen Biotech, LLC to accelerate the development of promising small molecule drug candidates for haematological cancers.

As part of the partnership, Novera, a new Ontario biotechnology company, will discover and develop novel therapeutic compounds identified through OICR’s drug discovery program in partnership with University Health Network’s enabling technology and disease area biology, and coordinate the collaboration with Janssen, a pharmaceutical company of Johnson & Johnson. Additionally, Novera will

receive an upfront payment and is eligible to receive various pre-clinical, clinical, regulatory and commercialization success-based milestone payments of up to a total of approximately $450 million plus tiered royalties on potential net sales of products.

Janssen has been granted an exclusive option to license, for all human uses worldwide, candidate drug(s) that have been identified and will be advanced through the collaboration.

Janssen says it will assume responsibility for subsequent pre-clinical, clinical and commercial development once it exercises its option.

To see this story online visit http://www.laboratoryfocus. ca/?p=3620

doctoral scholar at the University of Montréal and first author of the study.

“Instead of having to fight this basic repulsion effect, we instead decided to embrace this force and build a novel signaling mechanism, which detects steric effects when a protein marker binds to the DNA test.”

The sensing principle is straightforward: the diagnostically relevant protein (green or red), if present, binds to an electro-active DNA strand, and limits the ability of this DNA to hybridize to its complementary strand located on the surface of a gold electrode. Francesco Ricci, a professor at University of Rome Tor Vergata who also participated in this study, explains that this novel signaling mechanism produces sufficient change in current to be measured using inexpensive electronics similar to those in the home glucose test meter used by diabetics to check their blood sugar.

Using this highly selective and sensitive DNA-based assay, the researchers were able to detect multiple protein markers directly in whole blood in fewer than 10 minutes, even if their concentration is 1,000 000 times less concentrated than glucose.

“A great advantage of this DNAbased electrochemical test is that its sensing principle can be generalized to many different targets, allowing us to build inexpensive devices that could detect dozens of disease markers in less than five minutes in the doctor’s office or even at home,” concludes Alexis Vallée-Bélisle.

Univalor, the commercial partner of the Université de Montréal, is supporting this project and has filed a patent application to protect the technology.

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Restoring vision with stem cells According to new findings published by professor Gilbert Bernier of the University of Montréal, transplanting photoreceptors produced by the directed differentiation of stem cells could be a treatment for age-related macular degeneration (AMRD), a common eye problem caused by the loss of cones.

Bernier’s team has developed a highly effective in vitro technique for producing light sensitive retina cells from human embryonic stem cells.

“Our method has the capacity to differentiate 80 per cent of the stem cells into pure cones,” professor Bernier explained. “Within 45 days, the cones that we allowed to grow towards confluence spontaneously formed organized retinal tissue that was 150 microns thick. This has never been achieved before.”

In order to verify the technique, Bernier injected clusters of retinal cells into the eyes of healthy mice.

The transplanted photoreceptors migrated naturally within the retina of their host.

The findings are particularly significant in light of improving life expectancies and the associated increase in cases of ARMD. ARMD is in fact the greatest cause of blindness amongst people over the age of 50 and affects millions of people worldwide. ARMD is caused by the degeneration of the macula, which is the central part of the retina that enables the majority of

eyesight. This degeneration is caused by the destruction of the cones and cells in the retinal pigment epithelium (RPE), a tissue that is responsible for the reparation of the visual cells in the retina and for the elimination of cells that are too worn out. However, there is only so much reparation that can be done as we are born with a fixed number of cones. They therefore cannot naturally be replaced. Moreover, as we age, the RPE’s maintenance is less and less effective – waste accumulates, forming deposits.

“Differentiating RPE cells is quite easy. But in order to undertake a complete therapy, we need neuronal tissue that links all RPE cells to the cones. That is much more complex to develop,” Bernier explains, noting that he believes his research team is up to the challenge.

Beyond the clinical applications, Bernier’s findings could enable the modelling of human retinal degenerative diseases through the use of induced pluripotent stem cells, offering the possibility of directly testing potential avenues for therapy on the patient’s own tissues.

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Destructive disease shows potential as a cancer treatment

Mads Daugaard, an assistant professor of urologic science at UBC.

Scientists at the University of British Columbia, Vancouver Coastal Health and the BC Cancer Agency have discovered a protein from malaria that could one day help stop cancer in its tracks.

This new approach, which halted the growth of various tumours in mice, was based on a discovery by collaborators at the University of Copenhagen. While exploring why pregnant women are particularly susceptible to malaria, they found that the mosquito-borne parasite produces a protein that binds to a

particular type of sugar molecule in the placenta.

That discovery led to another: that same sugar molecule is also found in most cancers. This commonality is understandable, because both cancers and placentas grow rapidly, often pushing aside other tissues in the process.

It also means that the sugar molecule could be a target for anti-cancer drugs, and that the malarial protein, called VAR2CSA, could provide the tool for carrying such drugs to tumours.

“Scientists have spent decades trying to find biochemical similarities

between placenta tissue and cancer, but we just didn’t have the technology to find it,” said project leader Mads Daugaard, an assistant professor of urologic science at UBC and a senior research scientist at the Vancouver Prostate Centre, part of the Vancouver Coastal Health Research Institute.

“When my colleagues discovered how malaria uses VAR2CSA to embed itself in the placenta, we immediately saw its potential to deliver cancer drugs in a precise, controlled way to tumours.”

To test that theory, Daugaard and colleagues enlisted the expertise of John

Babcook and his team at The Centre for Drug Research and Development (CDRD). They attached a novel toxin to VAR2CSA and treated hundreds of normal and cancer cell lines. The drug compound specifically targeted and killed more than 95 per cent of the cancer cell lines.

The drug was then tested on mice that were implanted with three types of human tumours. With non-Hodgkin’s lymphoma, the treated mice’s tumours were about a quarter the size of the tumours in the control group. With prostate cancer, the tumours completely disappeared in two of the six treated mice a month after receiving the first dose. With metastatic breast cancer, five out of six treated mice were cured from metastatic disease. The mice showed no adverse side-effects, and their organs were unharmed by the therapy. The results were published in Cancer Cell.

“This is an extraordinary finding that paves the way for targeting sugar molecules in pediatric and adulthood human cancer, and our groups are vigorously pursuing this possibility together,” said Poul Sorensen, a UBC professor of Pathology and Laboratory Medicine and distinguished scientist with the BC Cancer Agency and cosenior investigator on the study.

“There is some irony that a disease as destructive as malaria might be exploited to treat another dreaded disease,” adds Ali Salanti, a professor of immunology and microbiology at the Centre for Medical Parasitology, at University of Copenhagen.

Two companies, Vancouver-based Kairos Therapeutics and Copenhagenbased VAR2 Pharmaceuticals, are developing the compound for clinical trials in humans, which will take another three to four years.

To see this story online visit http://www.laboratoryfocus. ca/?p=3569

Agilent Technologies backs new life science research Facility at Carleton University Agilent Technologies Inc. announces the opening of a new center for life science research in partnership with Carleton University in Ottawa, Canada.

Designed to advance multiomics research, the Carleton Mass Spectrometry Center located in the university’s department of chemistry, is equipped with state-of-theart mass spectrometers, gas and liquid chromatography systems

and bioinformatics tools from Agilent.

“This partnership will enable Agilent to develop new innovative mass spectrometry-based omics workflows for life science research,” said Agilent’s Steve Fischer, marketing director, academia and government. “It will make possible new biological discoveries using integrated biology to understand the mechanisms of disease.”

Agilent tools make it easier for scientists to combine, analyze and

visualize data from experiments in genomics, proteomics, transcriptomics, metabolomics and lipidomics. As such, the Carleton Mass Spectrometry Center will be an analytical resource for researchers and industrial partners across Canada.

The center is also using a new analytical method developed by two of the university’s professors, Dr. Jeffrey Smith and Jeff Manthorpe. The new method, known as TrEnDi (trimethyl-

ation enhancement using diazomethane), increases the sensitivity of mass spectrometry analyses by assigning a fixed, permanent positive charge to amino groups.

It allows for increased sequence coverage and peptide detection in proteomics analyses, and better detection in metabolomics and lipidomics analyses.

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Laboratory Focus November/December 2015

Bio-Rad’s Droplet Digital™ PCR proves highly reproducible at identifying viral RNA mutations in clinical samples Bio-Rad’s Droplet Digital PCR (ddPCR™) technology identifies viral RNA mutations in clinical samples with greater precision, sensitivity, and reproducibility than quantitative reverse-transcription PCR (RT-qPCR), according to a new study in the Journal of Virological Methods (November 2015).

The published paper is the first to directly compare ddPCR technology to RTqPCR with multiplexed assays using the same reaction mix and cycling protocol such that all variables are held constant except the platform (real-time PCR or digital PCR).

“It is the first article that outlines an optimization strategy with associated data for running multiplexed experiments using ddPCR technology,” said Sean Taylor, an application scientist at Bio-Rad and the paper’s lead author.

Sensitive Detection of Viral Mutations Numerous circumstances can lead to a weakened immune system, making the

body more susceptible to viral infection. Knowing whether the infection is developing resistance to certain drugs is key to providing optimal treatment. Such resistance can often develop from a single, spontaneous point mutation in the viral RNA. Using a mixture of mutant and wild-type viral RNA purified from 2009 pandemic flu patients, Bio-Rad scientists and collaborators from the CHU de Québec hospital affiliated with Université La-

Dr. Mike Sapieha wins André-Dupont prize

Dr. Mike Sapieha has been named as the recipient of the 2015 André-Dupont prize for young researchers.

The André-Dupont prize is awarded annually to honour the accomplishments of a young researcher with less than ten years of independent research experi-

ence. Sapieha is the director of the Neurovascular Ocular Disease Research Unit at the Maisonneuve-Rosemont Hospital Research Centre and he holds a Canadian Research Chair in retinal cellular biology. He is also professor in the Departments of Ophthalmology and of BioChemistry of

val (Canada) showed that ddPCR technology markedly increased the sensitivity (>30fold) and precision (>10-fold, p < 0.05 for both inter- and intra-assay variability) of mutation abundance quantification when compared to RT-qPCR. A brief video that outlines the technical aspects of the paper can be downloaded here.

Because Droplet Digital PCR is based on absolute quantification, it can remove much of the variability intrinsic to RTqPCR, which relies on relative

the University of Montréal, as well as Associate professor in the Department of Neurology and Neurosurgery at McGill University.

Dr. Sapieha’s work on vascular retinal diseases such as diabetic retinopathy and age-related macular degeneration is partially financed by AmorChem, a venture capital group.

These diseases represent the leading cause of blindness in developed countries.

To date he has published nearly 60 papers in renowned journals such as Cell Metabolism, Nature Medicine, Science Translational Medicine, Journal of Clinical Investigation and Blood and Circulation.

To see this story online visit http://www.laboratoryfocus.ca/?p=3540

quantification. Researchers discovered a statistically significant correlation between two independent ddPCR datasets that was not found with RT-qPCR, allowing for accurate identification of a residual mutant viral population.

Pursuing a Precise Diagnostic for Virology Guy Boivin, who holds the Canada Research Chair in Influenza and Other Respiratory Viruses, led this research.

Boivin’s lab has been develop-

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ing diagnostics with improved precision and earlier detection ability for influenza sub-populations that grow resistant to oseltamivir (Tamiflu).

“Influenza research, especially translational research, needs rapid and reproducible methods,” Boivin said. “We plan to use Droplet Digital PCR to follow the fate of immuno-compromized patients on antiviral therapy.”

Influenza is only one of many viruses that would benefit from earlier detection. This ddPCR-optimized method could be applied to investigate mutation populations in other viruses such as HIV and hepatitis.

“Our method is a practical protocol that researchers should follow to ensure a high level of confidence in their data,” said Taylor. “Hopefully this will spark more interest in virology while helping scientists in other fields learn how to optimize their ddPCR experiments and reap the full benefits of the technology.”

To see this story online visit http://www.laboratoryfocus. ca/?p=3581

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Appointments

RepliCel Life Sciences Inc. has appointed Geoff MacKay as an independent director of the firm.

Over the past 20 years, his career has been focused in the field of regenerative medicine. He is currently CEO of AVROBIO Inc., a clinical stage company focused on delivering step-change cell and gene therapies targeting cancer and rare disease. Previously, he spent

Geoff MacKay

11 years as CEO of Organogenesis Inc. in Boston. He is credited with helping build Organogenesis into the leading cell therapy business.

MacKay also has a strong pharma heritage, having spent 11 years at Novartis where he held senior leadership positions within the immunology franchise in Canada, USA and at the global office in Basel Switzerland. Other examples of his broad international experience include: chairman of the board of MassBio, chairman of the board of the Alliance of Regenerative Medicine, advisory council to the Health Policy Commission for Massachusetts, Deans advisory Council Western University School of Podiatric Surgery, and chairman of Audit Committee of the Center for Commercialization of Regenerative Medicine (CCRM).

Robert Verhagen has resigned as president and CEO of Helix BioPharma Corp. and is no longer a member of the company’s board of directors. The company intends to appoint Yvon Bastien, chairman of the board, to assume the role of president and

CEO on an interim basis. Bastien joined Helix’s board of directors in 2013 and has over 30 years of experience in the life sciences industry. His previous leadership roles include CEO and president at Sanofi Canada, founder and president at Delta Healthcare and president at Jouveinal. Additionally the company has appointed Gary Littlejohn as a director and consultant to Helix. Littlejohn brings over 30 years of experience in the financial and biopharmaceutical industries. From 2008 to 2015, he served as the CEO and advisor to the chairman of the Arab National Investment Company, the investment banking subsidiary of Arab National Bank located in Riyadh, Saudi Arabia. His other past roles include executive vice-president and director of Ecopia BioSciences Inc., a publicly-listed Canadian biotechnology company and director and audit committee member of Aegera Therapeutics Inc., a Canadian privately-held biotechnology company. He has also held senior investment banking positions with investment banks in Canada.

The executive committee of the Université de Montréal has appointed Jacques Bernier and Jacques Parisien to the board of directors of the Institute for Research in Immunology and Cancer (IRIC) at the Université de Montréal for a three-year term. Bernier, a managing partner at Teralys Capital, is an engineer by training and former senior vice-president of the Solidarity Fund QFL. He is a venture capital specialist, primarily in the field of technological innovation. Bernier has also been an active stakeholder in more than a dozen emerging high-tech companies as founder or CEO, or as angel investor with young entrepreneurs.

Parisien is a corporate director and advisor to businesses. Trained as an attorney, he has devoted his career to the communications industry. He also served as a member of the executive committee of Bell Media until he retired in December 2013. Earlier he had been part of upper management at Astral Media since 1994, most recently as executive vice-president and chief operating officer until its acquisition by Bell Media.

He sits on the board of a number

of companies, including Investors Group, Mackenzie, Square Victoria Communications Group and Gesca.

Contract research organization KGK Inc. has named Skip Hammock as its new director of business development in the U.S. In this role, he will be responsible for identifying new business opportunities, building partnerships and managing key client relationships. Hammock has been featured in the Nutritional Outlook People to Watch Directory, as well as in the Wall Street Journal for his pioneering work with Dean Mosca and Pharmachem on chia seeds.

Prior to this appointment he was director of technical affairs for Pharmachem Labs.

ing, managed markets and sales leadership.

Norma Biln, CEO of Vancouver’s Augurex Life Sciences Corp., has been elected as the new chair of BioTalent Canada’s board of directors. A non-profit human resource organization for Canada’s bio-economy, BioTalent Canada works with corporate partners and national and provincial biotechnology member associations to ensure Canada’s biotech businesses have access to the most skilled talent available. Prior to her role as CEO of Augurex, she began her career in clinical research with Pfizer Canada after completing

Tornado Spectral Systems Inc. has named Dr. Andrew Boorn as its new CEO. Dr. Boorn, who currently serves as chairman of the Tornado Spectral Systems board, previously served as president of Bruker Chemical and Applied Markets Division, as chief operating officer at ABSciex, and as president at MDS Analytical Technologies.

He received his B. Sc. in Chemistry from Thames Polytechnic, his a PhD in Analytical Chemistry from the Georgia Institute of Technology, and has an MBA from the University of Toronto. ‘ Telesta Therapeutics Inc. has named Brian J. Groch its new chief commercial officer. In this role he will be responsible for leading the development and execution of Telesta’s commercial strategy beginning with the U.S. commercial launch of MCNA1 for 2nd line high risk non-muscle invasive bladder cancer. He has more than 25 years of global commercial experience having held positions in both top-tier and start-up U.S. biopharmaceutical companies. Most recently he was the vice president of market access at Horizon Pharma. Prior to that he helped build the commercial organization at Dendreon in preparation for the launch of Provenge™. A seasoned biotechnology and pharmaceutical industry professional, his broad experience in the commercial sector includes multiple product launches at Novartis and Merck where he held positions in market-

Norma Biln

her Bachelor of Science in Physiology at McGill University. She has held senior positions with Pfizer Canada, Amgen Canada and Abbott Laboratories. She later joined Stressgen Biotechnologies as director of corporate market development and then as director of sales and marketing. She also served in a senior consulting capacity with Aspreva Pharmaceuticals on business development, commercial and communications initiatives. Biln holds a Master of Business Administration degree. She succeeds François Schubert, who recently retired as general manager & COO of the Research Institute of McGill University’s Health Centre in Montréal and was recently named to the Order of Canada for his career contribution.

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Laboratory Focus November/December 2015

Pharma Notes

Aeterna Zentaris says it intends to shut down its Quebec City offices by the end of December, 2015, moving the bulk of its functions and operations to Charleston, SC. The company, which specializes in developing oncology and endocrinology treatments with a focus on women’s health, did not confirm how many employees would remain with the company. The company also reported chief accounting officer Keith Santorelli will fill in as a replacement for chief financial officer Dennis Turpin, who is leaving the company. Aeterna Zentaris was founded in 1991 as Aeterna Laboratories. In May, 2014, the company selected Charleston, SC as the new location for its North American business and global commercial operations.

DelMar Pharmaceuticals, Inc. (Vancouver, BC and Menlo Park, CA) has released preclinical data showing the effectiveness of its lead product VAL-083 against cisplatin-resistant ovarian cancers. VAL-083 is a bi-functional alkylating agent, whose cytotoxic activity is due to the formation of DNA cross links at the N7 position of guanine. Unlike platinum-based chemotherapies such as cisplatin, carboplatin and oxaliplatin, which predominantly form

intrastrand DNA crosslinks, VAL-083 is believed to derive its anti-cancer activity via interstrand DNA cross-links, which leads to a distinct downstream of biological events within the tumour causing apoptosis and cancer cell death. In prior NCI-sponsored clinical studies, VAL-083 demonstrated clinical activity against a range of tumour types, including ovarian cancer. The current study investigated the activity of VAL-083 in multiple ovarian cancer models including both cisplatin-sensitive (A2780); and cisplatin-resistant (2780CP16, OVCAR-10, Hey and OVCA-433) phenotypes in vitro. The data support the potential of VAL-083 to circumvent drug-resistance in the treatment of ovarian cancer.

Following its submission to the U.S. Food and Drug Administration (FDA) for review, Oncolytics Biotech Inc. (Calgary, AB) reports that the Investigational New Drug Application containing the protocol titled: “A Phase 1b study

of pembrolizumab (KEYTRUDA®) in combination with REOLYSIN® (pelareorep) and chemotherapy in patients with advanced pancreatic adenocarcinoma,” is now active. The study will enroll patients 18 years or older with histologically confirmed advanced or metastatic pancreatic adenocarcinoma who have failed, or did not tolerate, first line treatment. It is an open-label Phase 1b trial designed to determine the safety and dose-limiting toxicities of REOLYSIN® and chemotherapy (gemcitabine or irinotecan or fluorouracil, at the treating physician’s preference) in combination with pembrolizumab. Secondary endpoints include overall response rate and progression free survival by immune-related response criteria; overall survival; and effects of REOLYSIN® and pembrolizumab when administered in combination.

Canadian antibody therapeutics company Zymeworks Inc. (Vancouver, BC) reports it has reached an

agreement with German contract development and manufacturing company ProBioGen AG. As part of the agreement ProBioGen will complete cell line development of a Zymeworks bi-specific antibody product candidate, applying its GlymaxX® Technology to enhance antibody-dependent cell-mediated cytotoxicity (ADCC).

the sales capacity of Citagenix by investing an additional $2.25 million in Citagenix in the next year. Antibe adds that it will acquire the remaining 15 per cent interest in Citagenix upon fulfillment of a regulatory condition.

Citagenix will operate as a subsidiary of Antibe.

Resverlogix Corp.

(Calgary, AB) has commenced a Phase 3 clinical trial called ‘BETonMACE’ with its lead drug apabetalone (RVX-208) in high-risk patients with coronary artery disease (CAD) and type 2 diabetes mellitus (DM).

Resverlogix has received initial approval from the regulatory authority and ethics committee in the first three countries: Belgium, Hungary and Israel, which will represent approximately 15 investigative sites of an expected 175 site trial. The first site initiation visit has been held and with the drug now available to the centers, enrollment of patients will commence. Over the course of the coming months, additional investigative sites will be activated.

Antibe Therapeutics Inc. (Toronto, ON) has entered into a share purchase agreement to acquire an 85 per cent interest in Citagenix Inc., a Montréalbased sales and distribution company with a focus on regenerative medicine. Citagenix markets, manufactures, sells and distributes a broad range of high-quality dental and orthopaedic surgical products, as well as a line of highest-quality, German-made surgical instruments. Citagenix has a fully established commercial infrastructure with annual revenues of $9.7 million for the 12-month period ending August 31, 2015. Antibe has agreed to further develop

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RepliCel Life Sciences Inc. (Vancouver, BC ) reports that it has enrolled the first three participants in its Phase 1 clinical trial (NCT02391935) evaluating its RCS-01 product. RCS01 is being developed as a potential treatment for UV-damaged and aged skin.

It is a cell-based product comprised of non-bulbar dermal sheath (NBDS) cells isolated from hair follicles harvested from a small biopsy taken from the back of the participant’s scalp. The single-center study, located at IUF Leibniz-Institut für umweltmedizinische Forschung gGmbH in Düsseldorf, Germany will include a total of 30 male and female participants between the ages of 50 and 65 years.

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HPLC Compendial Pharmaceutical Methods Allowable Adjustments to Pharmacopoeia Methods for Isocratic and Gradient Separations

Effective August 2014, the United States Pharmacopeia and the National Formulary (USP-NF) published the latest revision to General Chapter <621> on Chromatography that further clarifies what “allowable adjustments” can be made to USP methods without having to revalidate these methods. In other words, any of these changes made to a particular method would still meet the original system suitability requirements. Understanding this latest revision is critical to improving productivity and cutting costs in any lab environment, yet it can be overwhelming to many less experienced chromatographers.

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enerally these USP monographs were created for older generic drugs that are still manufactured and sold worldwide, and many of these methods were developed on older materials and are time-consuming to run.

To increase productivity in the lab, improvements must be made to these methods in order to reduce these lengthy run times while still maintaining the system suitability requirements defined by the monograph.

Previous versions of USP <621> simply said that adjustments could be made to help meet system suitability; however, the extent of an “adjustment” was not defined. The 1999 revision then put restrictions on the amount of adjustment that could be made before revalidation was necessary. Nearly a decade later, the USP35-NF30 S2 (2007 revision) incorporated additional clarification to allowable adjustments, harmonized efforts with European Pharmacopoeia (Eur. Ph.), and also included a new tool to help determine column “equivalency”. Today, the latest USP37-NF32 S1 (2014 revision) provides a much clearer definition of what is allowable.

Before we dive into the redefined allowable adjustments, let’s review the definition of system suitability which

is an integral part of HPLC methods and can be determined from a variety of parameters. Suitability verifies the system is adequate for the intended analysis. It is generally performed by replicate injections of suitable standard or other solution, as specified in method. Keep in mind, each HPLC method in a USP monograph may have its own specific system suitability requirements. And for these compendial methods, results are not valid unless system suitability requirements can be successfully met. Here is a quick review of some suitability parameters you will need to understand: Resolution (Rs) ensures closely eluting compounds are resolved. It establishes resolving power of the system, where column efficiency contributes to resolution and column efficiency can affect sensitivity. Efficiency can be specified for system suitability, but it’s not a true measure of the resolving power of a system.

Signal-to-Noise (S/N) is critical for accurate identification & quantitation. It is best if the noise measurement is taken before and after the peak of interest.

H = height of the peak of interest from peak apex to a baseline extrapolated over a distance ≥5X times the peak width at half height (W1/2); h = difference between largest and smallest noise values observed over a distance ≥5X peak W1/2 and, if possible, situated equally around the peak of interest

Symmetry Factor (As), also referred to as Tailing Factor (T), is a measure of peak symmetry and important for defining peak shape. Poor peak shape can affect quantitation and method precision. There are many different ways to measure this value (e.g. peak symmetry, peak asymmetry) yet most chromatography software will allow you to choose USP tailing.

W0.05 = width of peak at 5% height f = distance from the peak maximum to the leading edge of the peak, the distance being measured at a point 5% of the peak height from the baseline

Allowable Adjustments and System Suitability So now that we understand the critical method values, what are the “allowable adjustments” presented by the USP and how will they affect system suitability? First off, let’s break down the key points of USP <621> into the following: • Defines chromatographic terms and procedures • Allows for adjustments to methods • “in order to comply with system suitability…”

• when “it may be desirable to use a column with different dimensions…”

• “only when suitable standards (including Reference Standards) are available for all compounds used in the suitability test and the adjustments or column change yields a chromatogram that meets all the system suitability requirements specified in the official procedure.”

• “are not to be made in order to

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Laboratory Focus November/December 2015

Feature Figure 1

SEPARATIONS

Component

United States Pharmacopoeia (USP)

Mobile phase minor component (≤ 50 %)

± 30 % Relative; Cannot exceed ± 10 % Absolute change; Cannot be reduced to zero

Mobile phase pH

± 0.2 pH units

Buffer concentration

± 10 %

Column temperature

± 10 °C

Injection volume

Can be adjusted as much as needed; must be consistent with linearity, precision, and detection reqs.

Detector wavelength

Cannot be modified

Flow rate

± 50% (at given ID)

Column inner diameter

Can be adjusted so long as linear velocity is maintained

Column length

Column length (L) to particle size diameter (dp) ratio can be adjusted between -25 % and +50 %*

Particle size

Column length (L) to particle size diameter (dp) ratio can be adjusted between -25 % and +50 %*

Stationary phase

No change of the identity of the substituent permitted

Guards

Same stationary phase as column; guard ID ≤ column ID; guard length ≤ 15% column length

*Alternatively (as for the application of particle size adjustment to superficially porous particles), other L/dp combinations can be used provided that the number of theoretical plates (N) is within -25 % to +50 %

GR36771015_W_1

Figure 1.

Allowable Adjustments to USP Methods for ISOCRATIC

Figure 2 Figure 2.

Allowable Adjustments to USP Methods for GRADIENT

SEPARATIONS

Component

United States Pharmacopoeia (USP)

Mobile phase minor component (≤ 50 %)

Changes to gradient composition are not recommended

Mobile phase pH

± 0.2 pH units

Buffer concentration

± 10 %

Column temperature

± 10 ˚C

Injection volume

Can be adjusted as much as needed; must be consistent with linearity, precision, and detection reqs.

Detector wavelength

Cannot be modified

Flow rate

For gradient separations, changes to flow rate are not allowed

• • • •

Column length

For gradient separations, changes to column length, particle size, or inner diameter are not allowed

Particle size

For gradient separations, changes to column length, particle size, or inner diameter are not allowed

Stationary phase

No change of the identity of the substituent permitted

Guards

Same stationary phase as column; guard ID ≤ column ID; guard length ≤ 15% column length

compensate for column failure or system malfunction” Defines the maximum allowable adjustments Adjustments may require additional validation Multiple adjustments should be considered carefully Addresses the continued trend toward <3 µm particles, superficially porous particles (i.e. core-shell particles), and fast LC / UHPLC

The maximum allowable adjustment is outlined in Figure 1, for isocratic

methods, and Figure 2, for gradient methods. Adjustments may require verification, and consider multiple adjustments carefully as they can have a cumulative effect on system performance. Also, changes in chemical characteristics of stationary phase, such as a change from L1 (C18) to L7 (C8), is a modification and will require revalidation.

Mobile phase composition can be altered for isocratic methods following the allowable adjustments provided in Figure 1. Adjusting the minor component in the mobile phase can

GR36771015_W_2

Column inner diameter For gradient separations, changes to column length, particle size, or inner diameter are not allowed

increase or decrease retention of the target analytes. However, for gradient elution (Figure 2) adjustments to the composition of the mobile phase may cause changes in selectivity and are not recommended.

Mobile phase pH of the aqueous buffer can be changed ± 0.2 units, which is applicable to both gradient and isocratic methods. Remember that the pH scale is logarithmic (1 unit = 10X increase), so a small change in pH can have a big impact on chromatographic performance.

The main strategy is to ensure the

mobile phase pH keeps the drug in one state; low pH can protonate acidic compounds (silanols), while high pH can neutralize basic compounds; avoid pH = pKa. For buffer concentration, the minor ± 10% adjustment allowed by USP will most likely not make much difference in method performance.

However, if buffer concentration is insufficient, pH can change within the mobile phase especially with large volume injections. Keep in mind, concentration is most critical at pH extremes of that buffer.

Column temperature is often a neglected method parameter and should always be controlled, even if the method calls for ambient temperature. Ambient temperature is relative and different throughout the year, in different labs, in different countries, and in different locations within a lab. Variations in temperature can cause shifts in retention time. Higher temperature can decrease mobile phase viscosity, improve column efficiency, lower column back pressure, and decrease analysis time. However, use caution as temperature changes may also affect selectivity.

Injection volume can be adjusted as much as desired as long as it is consistent with accepted precision, linearity, and detection limits. Note that excessive injection volume can lead to unacceptable band broadening, causing a reduction in column efficiency and resolution. These adjustments are applicable to both gradient and isocratic methods.

For isocratic separations only (not allowed for gradient separations), the ratio of column length (L) to the particle size (dp) must remain constant or within range between -25% to +50% of the prescribed L/dp ratio. Column ID can also be adjusted as long as the linear velocity is kept constant by adjusting flow rate (F), accordingly. A smaller column ID will help with solvent savings, reducing band broadening (sharper peaks), and increasing resolution (sharper peaks).

Flow rate can be adjusted ± 50% at any time for isocratic methods. Increasing flow is the easiest way to reduce run time. For example, 2X flow rate = ½ run time but with a slight decrease in resolution, so you need to make sure that the Rs still meets suitability requirements.

2

2

F2 = F1 x [(dc2 x dp1)/(dc1 x dp2)] USP <621> and Guard Columns Yes, in the latest revision guard columns are explicitly allowed. In HPLC procedures, a guard column may be used with the following requirements, unless otherwise is indicated

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2

2

F2feature = F1 x [(dc2 x dp1)/(dc1 x dp2)] Figure 3

When Should I Replace Guard Column?

in the individual monograph: a. The length of the guard column must be ≤15% of the length of the analytical column, b. The inner diameter must be the same or smaller than that of the analytical column, and c. The packing material should be the same as the analytical column (e.g. silica) and contain the same bonded phase (e.g. C18).

In any case, all system suitability requirements specific in the official procedure must be met with the guard column installed.

But why would one want to use guard columns? Guards protect valuable analytical columns by removing particulates and strongly retained sample components that may accumulate on column, increase lifetime of analytical column, and maintain

Figure 4

Guards protect valuable analytical columns by removing particulates and strongly retained sample components that may accumulate on column, increase lifetime of analytical column, and maintain high column efficiencies, resolution, and peak shape. ter chromatography results in higher productivity, which in turn results in greater cost savings.

Figure 4 shows the relationship between column efficiency, in plates per meter, as a function of particle size for fully porous and core-shell packed columns. As you can clearly see from this figure, columns packed with core-shell particles provide higher efficiency values than columns packed with fully porous particles of the same diameter. This means that, all other things being equal, using columns packed with core-shell particles will result in narrower analyte peaks than columns packed with fully porous particle of the same diameter.

This, in turn, means that our ability to resolve closely-eluting compounds is greatly increased when using coreshell particles. Please also note that the pressure will simply be proportional to particle diameter, independent of whether it is fully porous or core-shell in morphology. Thus, the core-shell columns will generate the same pressure as fully porous particle of equivalent diameter.

Also, the efficiency value for the

high column efficiencies, resolution, and peak shape. Figure 3 details the general criteria for when to replace guard columns or guard cartridge.

Upgrading from Fully Porous to Core-Shell Now let’s take a look at the allowable adjustments and how they can be incorporated with newer technologies on the market, such as moving to higher efficiency core-shell columns.

What is it that sets core-shell columns apart from conventional, fully porous packed columns? The answer is simple: columns packed with coreshell particles will deliver significantly higher efficiency (N) than columns packed with fully-porous particles of the same diameter.1 To the end-user, this means that you are going to see narrower peaks, improved resolution, and shorter run times. Bet-

Columns Packed with Fully Porous versus Core-Shell Particles

450 400

Fully Porous

Core-Shell

Efficiency( p/m)

350 300 250

1.3 µm and 1.7 µm particles taken were generated using 2.1 mm ID columns, while the efficiency values for larger particle columns were derived from 4.6 mm ID columns. This was done to reflect what the typical enduser will actually see in their methods, with most UHPLC methods being performed on narrow-ID columns while HPLC methods tend to be performed using 4.6 mm ID columns.

Caution should be taken when the adjustment results in a higher number of theoretical plates which generates smaller peak volumes, which may require adjustments to minimize extra-column band broadening by factors as instrument plumbing, detector cell volume and sampling rate, and injection volume. For gradient separations, changes in length, column inner diameter, and particle size are not allowed.

In conclusion, USP General Chapter <621> defines the “allowable adjustments” constrained within certain allowable values. These adjustments permit flexibility for users of compendial methods to greatly increase productivity in the lab by ultimately reducing run times while also minimizing solvent usage and cutting costs. System suitability must be met or revalidation will be required. The adjustments to particle size, column length, and column inner diameter are allowed for isocratic methods only. Upgrading to newer core-shell particle technology is a simple solution that can dramatically improve both isocratic and gradient separations. USP <621> also allows for guard columns as long as stated requirements for their use are met.

Reference: 1. Gritti et al., Journal of Chromatography A, 1217 (2010) 1589

200 150

Michael Klein is a Brand Manager for HPLC & UHPLC Products at Phenomenex, Inc.

100 50 0 5

3.5/3.6

2.5/2.6

1.7

Particle Diameter (µm)

1.3

To see this story online visit http://laboratory focus.ca/new-technologiesto-improve-hplc-compendialpharmaceutical-methods

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Laboratory Focus November/December 2015

feature

Co mp i le d b y t h e S o c i e t y f o r L a b o rat o r y A u tomation a nd S creening Reprinted with permission from the Society for Laboratory Automation and Screening (SLAS) and the SLAS Electronic Laboratory Neighborhood e-zine at http://eln.slas.org.

Laboratory Purchasing Trends 2015: Uptick Expected While not rebounding to 2011 levels, the survey responses obtained from the 2015 North American Survey of Laboratory Purchasing Trends generally point to a bit more optimism, fueled by increased project work across several industry sectors.

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ince 2008, the Society for Laboratory Automation and Screening (SLAS) and the Laboratory Products Association (LPA) have partnered to conduct an annual study that examines trends and changes in laboratory personnel and workload in addition to purchasing trends over nine categories: • Chemicals, reagents, solvents • Glassware, plasticware • Consumables excluding chemicals • Laboratory equipment <$2,500 • Laboratory equipment >$2,500 • Laboratory instruments <$5,000 • Laboratory instruments >$5,000 • Laboratory furniture • Laboratory automation With data gathered in December 2014 and reported February 2015

Figure 1

during SLAS2015 in Washington, D.C. Clark Mulligan, LPA president, confirms that members of both organizations are well positioned to measure their progress against others in their space through this key study.

“The Laboratory Products Association was founded in 1918 as the Scientific Apparatus Makers Association,” Mulligan says. “Our members are manufacturers and distributors of laboratory products and services such as glass and plasticware, chemicals, equipment and supplies used in scientific research and applied science and life science worldwide.”

K.C. Warawa, president of K.C. Associates, the marketing research firm contracted to conduct the study, mentions that while each year’s data provides helpful information, bench-

marking individual performance over time is most useful.

“Trending is the most powerful part about doing market research,” Warawa explains. “Because if you can see that something is changing, you can react to it. If you do a standard survey, it’s a snapshot in time.

Yes, it’s good to know that information but it doesn’t tell you what your marketing plans or your business plans should be because it doesn’t tell you where you’ve been or where you’re going.”

Laboratory Personnel and Workload “Expected hiring of personnel is a good indicator of what is happening in the lab,” Warawa states.

The SLAS/LPA study showed bleak

Figure 2

years from 2008 to 2010 with 17 per cent, 14 per cent and 12 per cent respectively for percentage of respondents expecting to increase their staff. With the exceptions of 2011 and 2012 when expected increases tallied 25 per cent and 21 per cent respectively, the number has remained in the mid- to high teens. In 2015, 15 per cent of firms responding expect to increase their staff (the lowest since 2010), 27 per cent would replace employees leaving, 54 per cent plan no hiring and 5 per cent expect no hiring and plan layoffs or early retirements.

This 2015 hiring plan varies greatly by type of organization. As illustrated in Figure 1, 22 per cent of independent/contract laboratories responding plan to increase their staffs as compared to 11 per cent of colleges/universities and 10 per cent of hospitals. Editor’s note: The 2015 SLAS Leadership Forum at SLAS2015 focused on strategies to replace decreasing funding from the National Institutes of Health for colleges and universities.

Laboratory workloads have been increasing over the eight years SLAS and LPA have been gathering data, Warawa says. As shown above, the January 2015 data shows 55 per cent of the respondents expect to increase workloads, 38 per cent expect the same workloads as the prior year and 7 per cent expect decreases. Reasons for expected increase in

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November/December 2015 Laboratory Focus www.laboratoryfocus.ca

feature Figure 3

workloads include additional projects, tests or business and same staff being more productive and responsible.

Also, as in previous years, increased workloads do not necessarily mean similar increases in personnel. For 2015, just 38 per cent of the respondents anticipating an increased workload expect to increase staff.

Spending Expectations Organizations expect to increase spending in 2015 over 2014 on chemicals, reagents, solvents (+3 per cent); laboratory equipment less than $2,500 (+2 per cent); laboratory instruments less than $5,000 (+1 per cent); laboratory furniture (+3 per cent); and laboratory automation (+1 per cent). Increased workloads and new business/projects are most of-

Figure 4 • SLAS/LPA 2015 North American Survey of Laboratory Purchasing Trends MORE http://www.slas.org/resources/information/industry-reports/ • R&D Trends Forecast MORE http://www.iriweb.org/Public_Site/RTM/Volume_58_Year_2015/JanuaryFebruary_2015/2015_RandD_Trends_Forecast.aspx • Laboratory Products Association MORE http://www.lpanet.org/i4a/pages/index.cfm?pageid=1 • K.C. Associates, Inc. MORE http://www.kcassociatesinc.com/index.html • Understanding the Purpose and Use of Benchmarking MORE http://www.isixsigma.com/methodology/benchmarking/understanding-purposeand-use-benchmarking/ • Who’s Hiring 2015 College Grads?

MORE http://www.cnbc.com/2015/04/23/whos-hiring-2015-college-grads.html

ten cited as the reasons for spending increases.

When looked at a bit differently – using a purchasing indicator – each product category in 2015 shows a positive difference over 2014.

Warawa describes the purchasing indicator. “Since the ‘stay the same’ category can be viewed as neutral/ zero growth, the ‘increase’ and ‘decrease’ categories are used to show the delta.” For example, in 2015 43 per cent of respondents expect to increase spending for chemicals, reagents, solvents; 45 per cent expect to stay the same and 12 per cent expect to decrease. In 2014, these percentages were 40 per cent, 44 per cent and 16 per cent respectively.

The purchasing indicator – or percent difference increase minus decrease – was 31 per cent in 2015 (43 per cent-12 per cent) and 24 per cent in 2014 (40 per cent-16 per cent).

Spending for laboratory automation is a key area for SLAS members. The 2015 data point to 18 per cent of respondents expecting to increase their spending for laboratory automation products, 76 per cent intending to spend the same as in 2014 and 6 per cent planning a decrease.

This tracks quite closely to previous years, pointing to “a very stable category with little fluctuation” per Warawa.

“The spending increase expectation for 2015 is conservative,” Warawa explains. “A full 55 per cent of those planning increases are in the 1-10 per cent range followed by 30 per cent in the 11-20 per cent range.”

A further breakdown of respondent organizations shows hospitals (29 per cent) and industry (23 per cent) are most inclined to increase spending on laboratory automation.

Industry organizations are those companies/corporations involved in areas of basic research, biotechnology, chemicals, clinical, environmental and pharmaceutical. Looking more closely at those market segments, 25 per cent of participants from the pharmaceutical segment expect an increase, and 23 per cent from the clinical segment say there will be an increase.

About the Respondents There were 815 responses to the survey from the United States and Canada in the study for a confidence level of 95 per cent ±3. Industry was the highest represented category accounting for 37 per cent of the responses. College/university was next at 28 per cent, government at 15 per cent and all other categories under 10 per cent each.

Research was most frequently identified as the department in which respondents work (35 per cent), fol-

lowed by central service laboratory departments (21 per cent), QA/QC (12 per cent) and development (11 per cent).

Basic research (not product related), education, environmental/water, clinical/diagnostics, service laboratory, biotechnology products and pharmaceuticals are among the wide variety of products/services represented by respondents.

SLAS Members Can Access Study Results The 2015 North American Survey of Laboratory Purchasing Trends 182-page report is available to duespaid SLAS members at SLAS.org. If you are not yet an SLAS member, you can still join to access the report.

“SLAS members can see how laboratories across North America are planning to invest in equipment, staffing and facilities in 2015,” says SLAS CEO Greg Dummer. “Understanding the priority concerns of other laboratory professionals and management helps our organization prepare to address member needs and expectations.”

In addition to the highlights reported here, the full report includes more detail on personnel and workload changes, laboratory products spending, non-capital and capital equipment budgets. Full data on responses gathered is provided, as is cross tabulation by organizational categories (i.e., industry, hospital, government, college/university, independent/ contract lab, contract research organization, contract manufacturing organization and foundation/nonprofit organization), departments (research, development, central service laboratory, QA/QC, production/ process control/monitors, management, purchasing and teaching/education) and by products/services (i.e., basic research, biotechnology, clinical/diagnostics, education, environmental and pharmaceutical).

These options allow readers to dig deep and compare their situations against specific items in the study.

SLAS plans to partner with LPA once again for 2016, and results will be presented at SLAS2016, Jan. 23 to 27, San Diego, CA.

To see this story online visit http://www. laboratoryfocus.ca/ laboratory-purchasingtrends-2015-uptickexpected

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Laboratory Focus November/December 2015

feature

By Jenny Boon

Illuminating hereditary cancers

Understanding hereditary cancer is life and death for Chiquita Hessels. In 2011, just ten months after her mother’s death from breast cancer, and one month after her maternal aunt’s passing from bowel and jaw cancer, Chiquita herself was diagnosed with breast cancer.

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ast year Chiquita sought advice about whether there was a hereditary connection behind her family’s cancer history. Fortunately, with investment from Genome British Columbia (Genome BC) and BC’s Provincial Health Services Authority (PHSA), the Lower Mainland Pathology and Laboratory Medicine’s Centre for Clinical Genomics has recently developed a new genetic panel test that looks for mutations in 14 of the more common genes that can cause cancer.

The use of a gene panel is a significant advancement in screening for a predisposition to cancer. Previously a pattern like the one found in Chiquita’s family could indicate a number of inherited conditions, meaning she would need to have a number of tests, one after another, to test for each possible inherited gene. This process previously took months and used many health care resources.

The new screening panel looks for mutations in all 14 genes at the same time so that final results are delivered faster. The outcome for Chiquita was a positive test for the gene causing Li Fraumeni Syndrome, a rare hereditary cancer disorder.

“For Chiquita, this means that we know what other cancers she is at risk of in the future, what screening tests would be best for her and what tests and cancer treatments she needs to avoid if they could be harmful to her,” says Dr. Gillian Mitchell, medical director of the Hereditary Cancer Program at the BC Cancer Agency. “Using a 14 gene panel rather than testing one gene at a time has really shortened the time needed to give Chiquita and her family the answers they need to look after their health, and provided cost savings to the health care system by doing one rather than multiple gene tests which means that we are able to offer genetic testing to more patients.”

This test result is just as important for Chiquita’s family’s health as it is for her own. Some blood relatives will have inherited the same gene mutation and some will not. Those with the mutation will be able to undertake effective cancer screening and preventative measures. Chiquita’s niece tested positive for the family-specific mutation using a targeted genetic test for that

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November/December 2015 Laboratory Focus www.laboratoryfocus.ca

Feature “The Hereditary Cancer Program at the BC Cancer Agency will be much enriched with this new test and all British Columbians will benefit.”

mutation alone, and her two teenage sons are undergoing testing.

The long-term objective of the project is to market the test Canadawide. Savings to the health care system could be significant in terms of the cost per test, but also in terms of reduced numbers of appointments and the reduced time to get final test results for patients and their health care providers.

While the 14 gene panel test has been a great practical step for patients, it cannot detect all the types of mutations that can occur in these genes. Mutations called copy number alterations (CNA) may not be reliably detected with the 14 gene panel test and may need another form of testing. With this new research project the Lower Mainland Pathology and Laboratory Medicine’s Centre for Clinical Genomics will develop and validate another test to detect CNA in all 14 genes simultaneously using a platform that is scalable and sustainable.

“Genomics is making a difference to the way we approach cancer diagnosis and treatment,” says Dr. Alan Winter, President and CEO of Genome BC. “The Hereditary Cancer Program at the BC Cancer Agency

will be much enriched with this new test and all British Columbians will benefit.”

Hereditary cancers are thought to account for between five and 20 per cent of cancer diagnoses, with the proportion varying for different tumour types. With the successful implementation of the project to identify CNAs in 14 genes, the BC Cancer Agency will soon be routinely screening for all the genetic variants in the most common 14 genes predisposing to breast, ovarian and colorectal cancers.

The project, Application of DNA microarray technologies to clinical testing in hereditary cancer syndromes is valued at close to $400,000 and was funded through Genome BC’s User Partnership Program (UPP).

To see this story online visit http://www. laboratoryfocus.ca/ illuminating-hereditarycancers

Opening up Oral Cancer

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ral cancer (OC) is a global health problem with high incidence and high mortality.

OC has worldwide impact, accounting for 274,000 new cases and 145,000 deaths each year. Among the most deadly cancers types, the 5 year survival rates for OC ranges from 30 to 60 per cent. Most troubling, however, is the lack of significant change in prognosis for this cancer over the last 50 years, even in developed countries.

In most cases, OC is treated surgically followed by adjuvant radiation therapy and chemotherapy treatments. Even successful treatment of OC often results in impaired abilities, disfigurement and diminished quality of life. New strategies for OC control are urgently needed to improve survival and quality of life for this often ignored yet devastating disease.

The key to controlling this disease is to develop strategies targeting more treatable precancerous stages, known as oral premalignant lesions (OPLs).

Prevention strategies, including screening and early detection of lesions at risk, require capacity that isn’t currently available.

A new research project funded by Genome BC and UBC Dentistry’s Oral Cancer Research Fund aims to use an innovative approach to assess a set of markers that have been validated to predict the progression of OPLs that could supersede presently available clinical and pathological tests.

For the past 15 years Dr. Catherine Poh and her team have been developing a method of gently brushing the inside of someone’s mouth for tissue, such as saliva, and then running a genetic test to check for cancerous cells.

“The brushing test, if successfully validated in clinical trials, will provide a non-invasive indicator for the possibilities of oral cancer; this will not only give patients living with OPLs greater certainty but also a cost-effective approach in directing patients to a disease management plan with better outcomes,” says Dr. Catherine Poh, oral pathologist and Associate Professor at UBC; Clinician Scientist, Integrative Oncology and Cancer Control Research Program, BC Cancer Research Centre. “Ultimately, with early intervention, we can reduce the incidence of oral cancer and improve patients’ quality of life”.

The significance of this project is not only to BC but to Canada and globally. In the near term, the test will be accessible for triaging patients diagnosed with low-grade lesions into a different followup schedule in BC. For patients with high-grade lesions and oral cancer this non-invasive test can be used after treatment for monitoring and follow-up for early identification of recurrence. Dr. Poh and her team estimate that each year this new test will benefit approximately 300 patients in BC referred through the BC Oral Biopsy Service.

“This is truly translational work that will have a significant contribution to oral cancer control,” says Dr. Alan Winter, president and CEO of Genome BC. “Dr. Poh’s work is just one of several projects that we are funding through these programs and each are equally innovative and important.”

Dr. Poh’s project, Development of a non-invasive, digital PCR-based molecular test for risk of oral cancer progression was funded through Genome BC’s Strategic Opportunities Fund (SOF).

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Laboratory Focus November/December 2015

New Products

Sequencing

Illumina Inc. announces the launch of the TruSight® Tumor 15, a nextgeneration sequencing (NGS) panel designed to identify sequence variants in 15 genes commonly associated with marketed therapeutics. The panels are optimized for low input DNA from tissue preserved in formalin and paraffin, as well as for damaged and degraded formalin-fixed, paraffin embedded (FFPE) tumour samples. This enables low frequency somatic variant detection from limited nucleic acid inputs. When paired with the Illumina MiSeq® system, the panel delivers high-quality sequencing with key content and features needed for tumour analysis in translational research. The panel is intended for research use only and not for use in diagnostic procedures.

Web: www.illumina.com/OncologyPanel

Spectrophotometers The Thermo Scientific NanoDrop One and NanoDrop OneC UV-Vis microvolume spectrophotometers are designed to help life science researchers gain a more complete understanding of sample quality. These new spectrophotometers introduce the Thermo Scientific Acclaro Sample Intelligence technology, which enables researchers to identify sample contaminants and obtain corrected concentration results; receive instant feedback about sample quality with on-demand technical support and guided troubleshooting; and confidently measure samples with embedded sensor and digital image analysis. Moreover, the NanoDrop One instrument with its high-resolution touchscreen interface is simple to use, while its powerful auto-range path length technology facilitates accurate measurements for concentrated samples with no need for dilutions. The patented NanoDrop sample-retention system measures 1-2 µL of sample in seconds without the need for cuvettes, making it a costand time-effective solution for busy labs. Workflows can be streamlined on the NanoDrop One instrument with the Auto-Measure functionality, while modern connectivity allows results to be shared and archived via Wi-Fi, Ethernet or USB. The NanoDrop OneC instrument contains both pedestal and cuvette measuring positions, increasing dynamic range and assay flexibility.

Web: www.thermoscientific.com/nanodrop

Mass Spectrometry Bruker has released its new rapifleX MALDI-TOF/TOF mass spectrometer. With its redesigned, next-generation TOF/TOF ion optics, the rapifleX system now offers significantly higher speed, mass resolution and mass accuracy. The rapifleX integrates a novel, 10 kHz smartbeam™ 3D scanning laser design for breakthrough mass-spec imaging capabilities.

It also offers dramatically improved spatial resolution, image contrast and quality, and a new ion source for superior robustness and throughput in pathology research. Tissue- and cell-type specific proteomics is a major advance for relevant biomarker discovery and identification, and requires MALDI tissue imaging studies which include the identifi-

cation of detected biomarker candidates for validation and the subsequent development of targeted assays. The rapifleX MALDI-TOF/ TOF extends the MALDI Tissuetyper® imaging capabilities with rapid, spatially resolved MS/MS data. It supports the patented ImageID™ workflow for biomarker discovery in MALDI imaging cohort studies by obtaining matching identifications of tryptic peptides in bottom-up imaging studies. In addition to next-generation tissue imaging performance, the rapifleX MALDI-TOF/TOF system is well suited for detailed protein characterization in life science research and biopharmaceutical laboratories. The rapifleX™ MALDI-TOF/TOF system is for research use only.

Web: www.bruker.com

Flow Meters Sierra Instruments introduces its new InnovaMass 240i and 241i vortex mass flow meters. The new iSeries has been specifically designed for precise flow energy management in steam, compressed air, natural gas and water applications. Capable of measuring five process variables with one instrument, the InnovaMass flow meters feature a Raptor II operating system which runs apps like FloPro and Dial-A-Fluid, and a robust Smart Interface Portal (SIP) software providing end-users with flow measurement precision. Forms of energy in flow include heat energy (BTU or joules) in steam or water, the potential combustive energy in natural gas, and the potential expansion energy in compressed air, to name a few.

Web: www.sierrainstruments.com

Software

Bio-Rad Laboratories, Inc. announces the release of its KnowItAll® spectroscopy software. One of the key enhancements of the new release is optimized corrections, capable of performing a computationally complex set of corrections on all query and reference spectra in a search to find the optimal match between the query and each reference spectrum. Multiple corrections are applied automatically to compensate for differences between spectra caused by the variability of different instruments and accessories and other factors including human error. This feature is critical as the inflexible mathematical algorithms traditionally employed in spectral searching cannot compensate for errors in spectra that are flawed. Moreover, while manual corrections can be made by expert spectroscopists, those less experienced in spectroscopy are often unaware of how to perform the necessary corrections on their sample spectrum to achieve the best result.

KnowItAll 2015 also features two new software applications as well as the addition of spectra to its collection of Bio-Rad spectral databases that include: KnowItAll QC Expert™, KnowItAll Deformulation Expert™ and New Spectral Data.

Web: www.bio-rad.com

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November/December 2015 Laboratory Focus www.laboratoryfocus.ca

New Products Well plates

The ExoComplete™ 96-Well Plate and ExoComplete™ Tube kits from Hitachi Chemical Diagnostics Inc. are an integrated, fast and easy system for exosome collection and mRNA purification.

Both products are intended for research use only of molecular biology applications. Neither are intended for the diagnosis, prevention, or treatment of a disease, nor has either been validated for such use either alone or in combination with other products.The ExoComplete™ system isolates exosomal mRNA from biological samples such as plasma in a 96-well filter plate format, or largevolume samples such as urine in a single collection tube format. Exosomes and microvesicles (EMVs)

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in body fluids are captured with Hitachi Chemical’s Exosome Isolation Plate or Exosome Collection Tube with a proprietary filter material. The highly porous material allows fast filtration of biological samples without clogging, and reproducible isolation of EMVs without the use of conventional ultracentrifugation. After lysing the captured EMVs, mRNA can be isolated through hybridization with single strand oligo (dT) immobilized in the wells of the 96-well mRNA Capture Plate. A wide variety of downstream applications become available following isolation of mRNA, including mRNA quantification, single and double-stranded cDNA synthesis, RT-PCR, real time quantitative RT-PCR (qPCR), and next-generation RNA sequencing.

Web: www.hcdiagnostics.com

EchoTherm™ SRC103

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Torrey Pines Scientific announces the release of its EchoTherm™ Model IC50, peltier driven, chilling/heating dry bath with exact sample temperature control. The unit is supplied with a temperature probe to insert directly into the sample or into the sample block. The probe senses the sample temperature or sample block temperature directly and sends that information to the unit to drive and control the temperature exactly where set. There is also a sensor in the heater plate for allowing the user to set the plate temperature and use the probe to monitor the sample temperature. The Model IC50 displays and controls temperature to ±0.1°C. It can freeze, chill or heat samples from -10.0°C to 110.0°C in assay plates, centrifuge tubes of all sizes, vials, test tubes and other sample containers. It is particularly well suited to the molecular biology lab for doing hybridizations, sample prep for PCR, ligations, enzyme reactions, deactivations and much more. The Model IC50 is UL, CSA, and CE compliant.

Web: www.torreypinesscientific.com

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Laboratory Focus November/December 2015

New Products

Assays

EMD Millipore announces the launch of two new assays kits, the MILLIPLEX® MAP Amyloid Beta and Tau Magnetic Bead Panel, and the MILLIPLEX® MAP Myokine Panel. Together these two kits enable the measurement of four key neurodegeneration biomarkers and 15 myokine proteins. The United States Food and Drug Administration (U.S. FDA) recently encouraged the exploration of amyloid beta 1-42, tau and phospho tau as biomarkers of Alzheimer’s disease and EMD Millipore’s MILLIPLEX® MAP Amyloid Beta and Tau Panel is the first commercially available multiplex kit that enables simultaneous measurement of amyloid beta 1-40, amyloid beta 1-42, tau and phospho tau. Secreted by skeletal muscle, myokines act as endocrine hormones that not only mediate skeletal muscle cell growth, but also affect immunity, neurological signaling and insulin response. The 15 myokines detected by EMD Millipore’s assay kit include brain-derived neurotrophic factor (BDNF) and irisin, whose once-debated function has been recently supported by proteomics studies.

Web: www.emdmillipore.com

Mass Spectrometry SCIEX introduces its next generation CESI-MS platform, the CESI 8000 Plus. This new platform further enables multiple experiments to be generated from as little as 5 microlitres (μL) of starting material. Combining this capability with the multi-segment injection methodology, one can process ten experiments in the time it would normally take to process one, with less than 1 μL consumed. This system is ideal for experiments where samples are limited, including microdialysates, needle biopsies, FFPE archives, rare circulating tumour cells or where samples are highly toxic. In addition, the innovation of neutral capillary surfaces further reduces system flow to less than 10 nanolitres/min (nL/min).

The CESI 8000 Plus delivers high resolution separations, improves ionization efficiency and reduces ion suppression. Optional Laser-induced Fluorescence, Diode-Array and Selectable Wavelength UV detector modules are available, enabling off-line method development capability on this platform. The CESI 8000 Plus enables the separation of intact protein isoforms followed by mass spectrometry for researchers who need to understand the critical characteristics of biotherapeutics in development. CESI-MS provides a liquid-phase ion mobility separation, which now makes it possible to resolve closely related proteoforms, glycoforms, phosphorylated species and other post translational modifications (PTMs) on proteins.

Web: www.sciex.com

Sample Management Ziath has launched the DataPaq™ Cube Rack Reader, a new camerabased scanner for more effective sample management. The DataPaq™ Cube utilizes a dual camera set-up and unique cuboid design providing a flexible system for scanning 2D datamatrix coded tubes housed in all currently available rack formats.The reader works with all currently available rack types and can scan and decode a 96 tube rack in less than two seconds using standard computer hardware. Additional features include the easy saving of images for troubleshooting and diagnosis, and a fully integrated design within a single chassis. New templates can be easily created to match less common rack formats. All data is exportable into native Excel, CSV, text, XML and JSON formats to allow for advanced LIMS and robotic integrations.

Advanced users can also send their results directly into a database.

Web: www.ziath.com

Protein Purification Kits Norgen Biotek has released new exosomal RNA kits for isolation of exosomes from plasma/serum, urine and cell culture media. The new kits are based on the use of Norgen’s proprietary resin to purify and concentrate the exosomes. The purified RNA is free from any protein-bound circulating RNA and is of the highest integrity. The purified RNA can be used in a number of downstream applications including real time PCR, RT-PCR, Northern blotting, RNase protection, primer extension, expression array assays and NGS. Additionally, the kits are simple, rapid and scalable and are designed to isolate all sizes of extracellular vesicle RNA, including microRNA. They do not require any special instrumentation, protein precipitation reagents, extension tubes, phenol/ chloroform or protease treatments.

Web: www.norgenbiotek.com

Fermentation Sartorius Stedim Biotech (SSB) announces the launch of its new ambr® 15 fermentation system, an automated micro bioreactor system designed to enhance microbial strain screening with advanced capabilities supporting fed-batch microbial cultures. It comprises 24 single-use stirred micro bioreactors (each with an 8-12mL working volume) integrated to a user-friendly, automated workstation. Delivering high oxygen transfer rates, rapid pH and feed additions, the systemis ideally suited for assessing the effects of different strains with microbial cultures. Additionally, it measures pH and DO every 12 seconds and there are pumped liquid lines for base and feed addition in each micro bioreactor, enabling tight pH control and a semi-continuous feed supply. Furthermore, the 10mL working volume allows multiple samplings throughout the fermentation run to assess culture growth and protein production, thus providing more detailed process understanding. Vessels are single use which eliminates cleaning and sterilization time.

Web: www.sartorius.com

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Laboratory Focus November/December 2015 www.laboratoryfocus.ca

app review

CloningBench

By: Thermo Fisher Scientific https://itunes.apple.com/us/app/cloningbench-calculators-tools/ id458617777?mt=8

Will new Liberal government mean a more science-friendly regime?

On November 4, Canada’s new Prime Minister, Justin Trudeau officially took office after winning a Liberal majority. One of his first acts was to make reforms to the way Canada approaches science.

For starters, Canada is now a country with two science ministers. As part of his new cabinet, Mr. Trudeau reestablished the minister of science posting appointing Kirsty Duncan, a medical geographer from the University of Toronto to the role, and naming Navdeep Bains as the new Minister of Innovation, Science and Economic Development.

According to the new administration, Duncan’s Ministry will cater to the interests of “basic” science researchers, while Bains’ Ministry will focus on “applied” research. That’s not to say that the two will be working in silos, but rather, the hope is that they will compliment each other’s efforts.

Moreover, after nearly a decade where the Prime Minister’s Office had exercised tight control over the release of information by Canadian scientists, these two new Ministries have already gone on record to promise this will not be the case under their watch.

“Our government values science values science and will treat scientists with respect….that is why government scientists and experts will be able to speak freely about their work to the media and the public” said new science and innovation Minister Navdeep Bains in a statement to the Toronto Star.

Early indications are the appointments are being embraced by Canada’s scientific community who see the moves as positive change, smoothing over strained relations between the previous government and scientists across the country.

There is also a feeling of cautious optimism, amongst them, and hope that more reform is on the horizon, including the reinstatement of a science commissioner or chief science officer of Canada. Harper’s government had phased out the position in 2008, replacing it with the Science, Technology and Innovation Council. It’s hard to say for certain which approach is the right one, but perhaps a mingling of the two would suffice.

Overall, the new government seems to be saying and doing all the right things when it comes to the best interests of scientists. In theory, the moves appear positive, but how it will all work in practice, we’ll soon find out.

Clean and stylish, this app will guide you through all laboratory cloning experiments.

Equipped with nine different tools and calculators, CloningBench features everything from bacterial growth timers to PCR mastermixes. Users can calculate nucleic acid concentrations, molar quantities and vector to insert molar ratios.

Finding correct buffers and concentrations has never been easier than with the Double Digest Finder, while the Competent Cell Selection Guide makes finding the perfect cell a seamless experience. Although the app is stubbornly stuck in portrait mode and only available for Apple products, it clearly comes loaded with enticing features – the only way to discover them all is to make the free download.

The Chemical Touch

By: Christopher Fennell https://itunes.apple.com/us/app/the-chemical-touch/ id288060442?mt=8 It’s not a pop song or a murder-mystery paperback: it’s an app centered on the periodic table and the individual elements that make it up. Although not a particularly fresh or innovative concept, the app holds more than what first meets the eye. Users can take the table into their own hands, recoloring the categories to correspond to density, boiling point or electronegativity. Tapping a discrete icon at the top left of the screen opens a new portal of information, divided into five categories: isotopes, reduction potentials, ionization energies, x-ray absorption/emission and general properties.

Should users desire more information, an internet button opens up to each element’s respective Wikipedia page. Before going in for the download, however, users should be aware of the $0.99 price tag – a small fee, but a fee nevertheless.

www.laboratoryfocus.ca

Laboratory Focus November/December 2015

NOVEMBER 2015 November 22-25 BCN-AI Bio Conference Venue: Edmonton, AB Tel: (780) 492-1760 Email: vcheng@ualberta.ca Web: https://events.gobigevent.com/ events-web-public/event/start/774;jse ssionid=df2i5ilfgn7kHC7Jl+XHD4Xe?0

November 25-27

Calendar

Twitter: @Pittcon Web: www.pittcon.org

March 30-April 2 AMMI Canada - CACMID Annual Conference 2016 Venue: Vancouver, BC Tel: 613-260-3233 Fax: 613-260-3235 Email: info@ammi.ca Web: www.ammi.ca

Canadian Science Policy Conference Venue: Ottawa, ON Email: info@sciencepolicy.ca Web: cspc2015.ca

APRIL 2016

19

JUNE 2016

April 17-20

June 6-9

World Congress on Industrial Biotechnology Venue: San Diego, CA Web: www.bio.org/events/ conferences/world-congressindustrial-biotechnology

2016 BIO International Convention Venue: San Francisco, CA Web: www.convention.bio.org/2016

DECEMBER 2015 December 8 LSO Annual Policy Forum Venue: Toronto, ON Tel: (416) 426-7293 fax: (416) 426-7280 e-mail: admin@lifesciencesontario.ca Web: www.lifesciencesontario.ca/ events/eventsCalendar/ FallSymposium2015.php

JANUARY 2016 January 11-14 J.P Morgan Healthcare Conference + Biotech Showcase 2016 Venue: San Francisco, CA Web: www.jpmorgan.com

January 23-27

FEBRUARY 2016 February 8-9 Bio CEO & Investor Conference New York, NY Web: www.bio.org/events/ conferences/bio-ceo-investorconference

February 24 LSO Annual Awards Gala Venue: Toronto, ON Tel: (416) 426-7293 fax: (416) 426-7280 e-mail: admin@ lifesciencesontario.ca Web: www.lifesciencesontario. ca/events/eventsCalendar/LSOGala2016.php

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Children’s MiraCle network funds

who rely on the support of Children’s MiraCle network

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What is Children’s Miracle Network?

Children’s Miracle Network® raises funds for 170 children’s hospitals in North America, 14 of which are in Canada. These hospitals, in turn, use the money where it’s needed the most.

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MARCH 2016 March 6-11 PITTCON 2016 Venue: Atlanta, GA Tel: (412) 825-3220 Fax: (412) 825-3224 email: info@pittcon.org

Learn more at: ChildrensMiracleNetwork.ca

96 Well? Done!

Eppendorf epMotion® 96—fast and precise 96-channel microplate processing The new Eppendorf epMotion 96 is a semi-automated electronic pipette for high precision pipetting in 96- and 384-well plates. Without changes to the system, a large volume range of 0.5 to 300 µL can be used. Its intuitive handling makes it a great tool for anyone in the lab.

> 0.5 to 300 µL with one system > Auto-detect function for tip size > Intuitive and industry proven software concept and convenient touch screen > Intelligent, preset applications: aspiration, dilution, multi dispense, pipette and mix

www.eppendorf.com/automation • 800-263-8715 031.A1.0131.B © 2015 Eppendorf AG.