Laboratory Focus August/September 2017

Pharmaceutical

Clinical

Chemical

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August/September 2017 Volume 21, Number 3 R&D News.................. 1

How to Measure pH In Protein-Containing Samples Page 9

Benefits of Highly Flexible Biopharma Facilities Page 11

Appointments............. 8 Pharma Notes........... 15 New Products........... 16 App Reviews.............. 18

Transparency, tracking sought in sale of GM salmon in Canada Unlike in several other countries, the Canadian government does not require that GM foods sold in the country to be labelled as such modified salmon without knowing it?

When reports of the presence of GM salmon in Canada surfaced over the August long weekend, several major supermarket chains were quick to say that they were not selling the product. Among those stores were Costco, Loblaws, Metro, Pete’s Fine Foods, and Sobeys.

Unlike in several other countries, the Canadian government does not require that GM foods sold in the country to be labelled as such. MP Pierre Luc Dusseault of the New Democratic Party tabled a bill that would have amended the Food and Drugs Act, however, his private member’s bill calling for the labelling of GM foods was rejected by the House of Commons in May. AquaBounty has labeled its genetically modified salmon, AquAdvantage Salmon.

“No one except AquaBounty knows where the GM salmon are,” said Lucy Sharratt of CBAN. “The company did not disclose where Continued on page 3

Genomics project looks to reduce adverse drug reactions in children A few weeks ago, Canada became the very first place in the world where genetically modified fish was being marketed – and not a lot of Canadians were even aware of it.

And therein lies the problem with the near-stealth way that about five tons of GM Atlantic salmon fillets from the U.S. aqua culture company AquaBounty ended up in still unknown Canadian stores.

“This is the world’s first sale of

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GM fish for human consumption and it has occurred without GM product labelling for Canadian consumers,” according to the Canadian Biotechnology Action Network, a group that monitors issues relating to genetically engineered foods.

The group said information about the sale of GM salmon in Canada was revealed in the company’s quarterly financial report.

Could you have eaten genetically

Pharmacogenomics will be used to predict a patient’s risk of developing an ADR Researchers at the University of British Columbia (UBC) and the BC Children’s Hospital Research Institute have partnered with health and wellness company Dynacare, to find solutions to reduce severe adverse drug reactions (ADR) in children.

This joint project, which received $3 million in funding through Genome Canada’s Genomic Applications Partnership Program (GAPP) and Genome British Columbia, will work toward integrating pediatric pharmacogenomic testing into the Canadian health care system.

Pharmacogenomics – the science of how an individual patient’s genetic makeup impacts his or her response to medication – will be used to predict a patient’s risk of

developing an ADR. Modern medicine has revolutionized healthcare and made a significant impact on patient longevity and quality of life. Unfortunately, many medications can also cause unintended side effects.

“Our overarching goal is to reduce and prevent ADRs – especially in vulnerable patient populations such as children,” said the project’s co-lead, Dr. Bruce Carleton, director of the Pharmaceutical Outcomes Program at BC Children’s Hospital and Professor & Division Head of Translational Therapeutics, Department of Pediatrics, Faculty of Medicine at UBC. Laboratory testing provided by Continued on page 3

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the GM salmon fillets were sold or for what purpose, and we’re shocked to discover that they’ve entered the market at this time.”

Vigilance OGM Quebec, a Montrealbased, not-for-profit GMO monitoring group, tweeted: “4.5 tons of GE salmon on the market without labelling, we are #1 guinea pigs in the world!” and later on Monday added, “Transgenic salmon is now sold in the country, without labelling.”

Media reports said that AquaBounty announced in August that it had sold approximately five tons of Salmon fillets in Canada after I received permission from health authorities.

AquAdvantage salmon are triploid.

It has three sets of chromosomes whereas most animals have two sets.

To create the salmon, a growth hormone regulating gene from a Pacific Chinook salmon, and a promoter from an ocean pout, was added to the Atlantic salmon’s 40,000 genes.

This enables the salmon to grow yearround instead of only during spring and summer.

The ocean pout is an eel-like fish with antifreeze proteins in its blood to help it survive in near-freezing waters in eastern Canada and New England.

The aim of the genetic modification is to increase the speed of growth of the salmon. The AquAdvantage Salmon fish grows to market size in 16 to 18 months rather than three years.

The company went through three years of testing before the Health Ministry and the Canadian Food Inspection Agency ruled in May that AquaBounty’s genetically modified salmon is “as safe and nutritious as conventional salmon.”

The salmon are raised in Panama.

However, AquaBounty said it plans to produce the fish in Prince Edward Island.

The company maintains that its genetically modified salmon are safe, nutritious and produced in a sustainable manner.

According to AquaBounty’s Web site, the company’s low impact fish farming method involves raising AquAdvantage salmon in land-based production systems away from the ocean.

Continued from page 1 Dynacare will inform how to improve the safety and effectiveness of the most commonly-used medications in children: antibiotics, analgesics and mental health medication. The tests are non-invasive and are conducted using saliva.

“Dynacare is proud to be a part of this initiative to make pharmacogenomic testing available to improve patient outcomes,” says project colead, Dr. Yvan Côté, general manager of Dynacare Next. “We want

“This eliminates the risk of escapes that could impact native fish populations and the risk of pollutants or contaminants that could harm marine ecosystems,” the company said.

The AquAdvantage salmon are produced sterile to safeguard the wild fish population.

AquaBounty also claims its salmon grows to market size using 25 per cent less feed that traditional Atlantic salmon in the market.

Agriculture Minister Lawrence MacAulay is holding several public consultations on the issue of GM foods across the country over the next two months.

The meetings will include stakeholders, Indigenous representatives, experts, and key policy makers, Up for discussion will be food affordability, accessibility, safety and conservation.

“Do I agree with GM? We have a regulatory system that’s sciencebased. We promote it worldwide. I promote it worldwide,” said MacAulay in an interview with the CBC. “If the science based regulatory system indicates food is safe for Canadians, I

agree that they’re safe for Canadians.”

However, groups like CBAN and Vigilance OGM are clamouring for transparency, better ways of alerting consumers of GM foods in the market place, and better federal government tracking of GM foods.

“We clearly need mandatory labelling of all GM foods,” said Thibault Rehn of the Quebec network Vigilance OGM. There is no federal government tracking of GM products in the market and members of parliament voted down a private members bill for mandatory GM food labelling in May, according to CBAN. GM salmon is approved for human consumption in the U.S. and Canada, but there is an import ban in the US until labelling guidelines are published, Sharratt pointed out.

“When it comes to GM foods, Canadian consumers are shopping blind,” she said.

to leverage technology in a way that can make medications safer and ultimately improve the delivery of care.”

The partnership also connects physicians and pharmacists across Canada in order to expand access to this innovative technology and ensure pharmacogenomic laboratory results are incorporated into medical decision-making.

“Using pharmacogenomics to reduce the risk of adverse drug reactions and guide treatment decisions in children is an integral part

of delivering precision health care,” said Dr. Catalina Lopez-Correa, chief scientific officer and vice-president, Sectors, at Genome BC. “This work reflects Genome BC’s ambition to translate genomics into everyday clinical applications, in particular at the primary care level, and improve health outcomes for all Canadians.”

To see this story online visit http://laboratoryfocus.ca/transparency-tracking-sought-in-sale-of-gmsalmon-in-canada/

To see this story online visit http://laboratoryfocus.ca/genomics-project-looks-to-reduce-adverse-drug-reactions-in-children/

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Clementia, Zymeworks lead Canadian biotech momentum

Recent mega initial public offerings by two Canadian biotechnology firms are shining the spotlight on the local biotech industry, according to the investment arm of the Business Development Bank of Canada (BDC).

Last week, Clementia Pharmaceuticals, a Montreal-based biopharmaceutical company successfully completed

a US$120M million IPO on NASDAQ. Earlier in June, Vancouver’s Zymeworks Inc. raised $85 million through its own IPO. “If more Canadian companies emulate Zymeworks and Clementia utilizing public markets to raise large rounds to finance growth, we believe that Canada can create strong, innovation based companies with an opportunity to be leaders in the industry, said Jérôme Nycz, executive vice-president, of BDC Capital. “As the most active venture capital investor in the country, we see these two companies as great models of what can be accomplished with visionary entrepreneurs complemented with a strong capital partner.”

Clementia is working on its major candidate product, Palovarotene, a retinoic acid gamma receptor agonist, for the treatment of progressive ossificant fibrodysplasia (POF). POF is s an ultra-rare bone formation disease. It

Anti-cancer vaccine may also tackle bad diet ‘vicious cycle’ It’s something that’s been experienced by almost anyone who has tried to go on diet. The moment you eat something you’re not supposed to, the more you have a craving for it. Researchers at CureLab Oncology Inc. call it’s the “vicious cycle of a bad diet,” and they believe an anti-cancer medication could break it.

A paper produced by the team proposes that a new biological agent developed the CureLab may prevent and alleviate diet-induced disorders. The researchers reported that the company’s Elenagen anti-cancer vaccine is able to reduce chronic inflammation which causes chemical alterations in the brain which triggers a craving for fatty foods. CureLab is a Boston based private biotechnology company developing biological agents against cancer and chronic inflammation.

The findings could have beneficial implications for therapy and treatments for people suffering conditions affected by diet, according Dr. Alexander Shneider, founder of CureLab and the senior author of the paper.

For example, restoring serotonin and MAO levels are mechanisms of action of anti-depressant drugs.

“We hope that in few years we would bring to market a novel agent against type 2 diabetes and metabolic disorders as well as diseases accompanying diabetes and metabolic syndrome such as heart diseases, depression, or psoriasis,” he said. “All of them are

dependent on chronic inflammation.”

The CureLab team of American, Ukrainian, Italian, and Russian scientists hypothesized that, by reducing chronic inflammation, Elenagen would break the vicious cycle reducing the negative effects of excessive diets.

Experimental testing has supported the hypothesis.

The work was performed on rats fed with a normal diet or high fat, high calorie food. Consumption of the unhealthy food resulted in metabolic misbalance, metabolic misbalance induced chronic inflammation, and chronic inflammation led to chemical alterations in the brain. Brain levels of the “satiety sensor”, serotonin, were reduced while the serotonin-degrading enzyme, MAO, was elevated. As a result, animals consuming fatty food had to eat more and their body mass index grew significantly quicker. This, in turn, further exacerbates metabolic dysfunction – a positive feedback loop.

To see this story online visit http://laboratoryfocus.ca/anti-cancer-vaccine-may-also-tackle-baddiet-vicious-cycle/

causes muscle tissue and connective tissue such as tendons and ligaments to ossify. It forms bones outside the skeleton and constrains movement.

Zymeworks is a clinical stage biopharmaceutical company focused on developing multifunctional biotherapeutics such as ZW25. ZW25 is based on the company’s proprietary Azymetric platform for IgG-like novel bispecific antibodies. Zymeworks is developing ZW25 as a best-in-class HER2-targeting antibody intended as a treatment option for patients with any solid tumor that expresses HER2.

The two companies are not the only Canadian biotech businesses raising large amounts of capital. Also in June, Repare Therapeutics, a Montréal developer of precision oncology drugs, raised US$86 million in Series A financing. And that only follows the footsteps of Versant Venture’s recent partnership with Bayer which raised US$225 million for the creation of the cell therapies startup, BlueRock Therapies.

Canadian companies, universities, and research centres have consistently produced groundbreaking innovation backed by strong science.

Renewed investment into the sector

by BDC Capital with its $135M Health-

care Fund announced in 2013 and increased investment from other Canadian biotech focused funds is beginning to “catalyze great companies, strong investment syndicates and increased international capital into the sector,” according to the BDC investment arm.

Another factor attracting capital is the strong investment performance of the underlying companies offering the prospect of appealing investment returns for investors.

“The rapid growth of these two new life sciences companies is in line with our fund strategy of supporting the best performing Canadian companies with the technology and talent to assume leadership at the global level,” said Dion Madsen, senior managing partner of the BDC Capital Healthcare Fund. “Canada has an advantage when it comes to attracting talent in the life sciences industry because of the country’s emerging tech clusters; the groundwork for an outstanding life sciences industry in Canada has been laid and is now coming to fruition.

To see this story online visit https://biotechnologyfocus.ca/ clementia-zymeworks-lead-canadian-biotech-momentum/

Caprion expands portfolio with biomarker for tuberculosis Caprion Biosciences Inc., a Montrealbased contract research organization, said its blood-based protein biomarker findings suggest host protein expression changes can be detected in early stage Mycobacterium tuberculosis (Mtb) infection.

Using ProteoCarta, Caprion’s mass spectrometry (MS) and multiple reactions monitoring (MRM-MS) platform, researchers were able to detect the protein expression even before tuberculin skin testing conversion and development of latent M. tuberculosis infection (LTBI).

“These findings are very significant and could impact the way we approach treatment, providing a solid basis to accelerate the development of predictive testing” said Eustache Paramithiotis, vice-president of discovery at Caprion.

Paramithiosis led the study in collaboration with Dr. Charles Bark, and Dr. W. Henry Boom, from Case Western Reserve University.

The new data, recently published in EbioMedicine, expands and strengthens Caprion’s existing portfolio of biomarkers assays for predicting and monitoring of active TB, supporting clients who are developing TB therapeutics and diagnostics.

LTBI is a state of persistent immune response resulting from Mtb infection but without evidence of clinically active TB.

Current immune-based tests for Mtb infection (LTBI) cannot distinguish recent from remote Mtb infection. Approximately 10 per cent of people with LTBI will develop active TB and are the primary source of TB spreading. Their identification is critical to efforts aimed at controlling TB. In this proteomic study, host proteins expressed differentially between patients uninfected and individuals exposed to M. tuberculosis through contact with family members, which were followed over a period of 12 months.

Caprion’s bioinformatic analysis determined multiple biomarker signatures correlating with subsequent development of an immune response recognizing Mtb. These biomarker signatures may demonstrate individuals recently infected by Mtb at high risk for developing active tuberculosis.

To see this story online visit http://laboratoryfocus.ca/caprionexpands-portfolio-with-biomarkerfor-tuberculosis/

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Laboratory Focus August/September 2017

news Intellipharmaceutics faces lawsuit over Rexista Things appeared to be going great for the Etobicoke, Ont.-based company Intellipharmaceutics International Inc., with its announcement that the U.S. Food and Drug Administration was reviewing its innovative tamper resistant opioid medication Rexista.

Then, things suddenly went the other other way.

Recently, Intellipharmaceutics’ investors had hired a Los Angeles law firm to investigate Intellipharmaceutics and its company’s officers for possible violation of federal security laws.

Intellipharmaceutics announced that it would defend itself a “purported” class action complaint filed in the U.S. District Court of the Southern District of New York.

The complaint, filed by a certain Shawn Shanawaz against Intellipharmaceuticas and two of its executives, alleges that the company and its officers violated Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 and Rule 10b-5 by making alleg-

edly false and misleading statements or failing to disclose certain information regarding Rexista.

The complaint seeks, among other remedies, unspecified damages, attorneys’ fees and other costs, equitable and/or injunctive relief, and such other relief as the court may find just and proper.

Before all this, Intellipharmaceutics said it was meeting with an FDA panel that will examine its new drug, Rexista. Media reports indicated that the share prices of the company spiked after this announcement.

Rexista is being positioned by the company as a tamper resistant tablet.

Among other things, Rexista contains a blue dye which would mark those who tamper with or crush the tablet. It also contains a nasal irritant designed to keep the drug from being easily inhaled with the application of heat or an open flame.

Rexista is intended as an abuse and alcohol-deterrent controlled-release oral formulation of oxycodone hydro-

chloride for the relief of pain, a press release from Intellipharmaceutics said. Rexista is bioequivalent to Purdue Pharma’s OxyContin.

Two days after the meeting with the FDA, the L.A. law firm Glancy Prongay & Murray LLP (GPM) issued a press release saying that it was looking into reports of alleged misconduct by Intellipharmaceutical executives.

The press release indicates that the investigation may have something to do with share prices of Intellipharmaceutical.

According to GPM the FDA committees voted that Rexista “had not demonstrated properties that can be expected to deter abuse” by the intravenous means and that there was not enough data to support the company’s claims of the product’s abilities to deter abuse by this means.

“On this news, the Company’s share price fell $1.13 per share, or 45.3% on July 27, 2017, thereby injuring investors,” GPM said.

The law firm then invited people

who have purchased Intellipharmaceutics or anyone that may have information or questions about the claims to contact GPM. Meanwhile, Intellipharmaceutics said “its management intend to vigorously defend against the allegations set forth in the complaint.”

To see this story online visit https://biotechnologyfocus.ca/ intellipharmaceutics-faces-lawsuitover-rexista/

DelMar prepares for patient enrollment in STAR – 3 GMB trials Vancouver-based biopharma firm DelMar Pharmaceutical reported that it has completed its first site initiation visit for its Phase 3 study of treatment for recurrent glioblastoma (GBM), the most common and aggressive primary brain cancer. Site initiation visits are generally the final step before patient enrollment.

The company’s Phase 3 Study in Temozolomide-Avastin (bevacizumab) Recurrent GBM or STAR -3 GMB, is an adaptive design, randomized, controlled pivotal Phase 3 clinical trial to assess the efficacy and safety of VAL-083 versus salvage therapy in patients with late-stage GMB. The study is aimed at individuals whose disease has progressed following prior treatment with temozolomide and bevacizumab, for whom there is currently no standard-of-care therapy.

GMB is an aggressive brain tumour.

Among the well-known people known to suffer from it is United States Republican Sen. John McCain of Arizona, according to Forbes. It is the same type of cancer which caused the death of Democratic Sen. Ted Kennedy as well as the son of former U.S. VicePresident Joe Biden.

The study is being conducted at the Dent Neurological Institute - the largest private neurology centre in North America seeing more than 250,000 patients annually. Dr. Laszlo Mechtler

will serve as principal investigator for the STAR-3 trial at Dent.

Mechtler is Medical Director of Dent Neurologic Institute as well as the Chief of Neuro-Oncology at Roswell Park Cancer Institute in Buffalo, NY. Current standard of care for GMB includes surgery, radiation and treatment with temozolomide (TMZ), however, “nearly all tumors recur and the prognosis for recurrent GBM is dismal,” according to DelMar. Second-line treatment with antiangiogenic agent bevacizumab has not improved overall survival (OS) and fiveyear survival is less than three per cent.

DelMar anticipates the initiation of additional centres and commencement of treatment under the STAR-3 protocol in the coming weeks.

A total of up to 180 eligible patients will be randomized at approximately 25 centres in the United States to receive either the investigational drug (VAL-083) or “investigator’s choice salvage therapy” in a 2:1 fashion.

Up to 120 eligible patients will be randomized to receive intravenous VAL-083 at 40 mg/m2 on days 1, 2, and 3 of a 21-day treatment cycle, for up to 12 21-day treatment cycles or until they fulfill one of the criteria

for study discontinuation. Up to 60 patients will be randomized to “investigator’s choice” control, limited to temozolomide, lomustine, or carboplatin, until they fulfill one of the criteria for study discontinuation.

The primary endpoint of the trial is overall survival of VAL-083 vs. the control arm. The statistical design between the two arms of the study is 90 per cent power, and is proposed to include an interim analysis at 50 per cent events for futility with O’BrienFleming superiority boundary and nonbinding, gamma (-5) futility boundary.

“The activation of the STAR-3 trial and initiation of recruitment in collaboration with Dr. Mechtler and his team at Dent is a momentous occasion for our company, and for the patients and their families who we hope will benefit from VAL-083,” said Jeffrey Bacha, chief executive officer of DelMar Pharmaceuticals.

“In particular, GBM is a type of cancer that has been devoid of new drug approvals improving overall survival for decades, which is why we believe that VAL-083 represents tremendous value in the oncology treatment market.”

To see this story online visit http://laboratoryfocus.ca/delmarprepares-for-patient-enrollment-instar-3-gmb-trials/

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August/September 2017 Laboratory Focus www.laboratoryfocus.ca

news Scientist discover how cells reverse tissue damage caused by heart attack Scientists from the University Bristol have found out how cells surrounding blood vessels are able to trigger the growth of new blood vessels. The study on the growth of new blood vessels could be critical in the development of a treatment for heart attack patients as well as gaining a better understanding of cancer.

The team led Paolo Madeddu, a professor of experimental cardiovascular medicine from the School of Clinical Sciences at the University of Bristol, found that pericytes stimulate angiogenesis or new blood vessel growth. Angiogenesis is important in the repair of tissues after an injury or a heart attack but it is also essential in the spread of cancer.

The U.K.-funded project studied how pericytes encourage the growth of new blood vessels and the role leptin.

It provides important new information about the mechanisms involved.

Leptin is a hormone that is produced by fat cells. It helps regulate energy balance in the body by inhibiting appetite.

The team’s findings were published

in Scientific Reports of the journal Nature.

“This new discovery doesn’t only have important implications for the treatment of heart attacks, which is when a main coronary artery gets blocked, but also cancer,” said Madeddu, who leads the ho leads the project at the Bristol Heart Institute. “These results reveal a new signalling mechanism that may have a far-reaching and significant impact on cardiovascular regenerative medicine.”

“Increasing leptin in pericytes in a damaged heart might help it to heal faster, whereas blocking the production

of leptin in cancerous pericytes might starve the tumour of nutrients and force it to shrink,” Madeddu added.

A typical treatment for heart attacks is coronary artery bypass surgery. In this procedure, doctors take blood vessels from a patient’s leg or other parts of the body, and use it to bypass the blocked artery in order to improve the flow of blood to the heart muscle.

The surgery is invasive. Patients also undergo a long recovery time.

The findings of the University of Bristol team may be instrumental in the development of an alternate treatment.

Madeddu and fellow researchers

found that pericyte produce 40 times more leptin when they are exposed to low levels of oxygen. The production of leptin continues until oxygen levels return to normal.

Their research also shows that leptin has several important actions which encourages new blood vessel growth in areas deprived of oxygen.

In most heart attack cases, a coronary artery becomes blocked. This cuts down the supply of blood to the heart and leads to heart damage.

By stimulating the growth of new blood vessels, pericytes have the potential to restore blood supply to a damage heart muscle following a heart attack.

“This translational research project is a good example of research that aims to benefit patients as soon as possible,” said Barbara Harpham, chief executive of Heart Research UK, “Understanding more about the processes involved may help pave the way for the development of new treatments for heart attacks which could replace coronary bypass operations.”

To see this story online visit http://laboratoryfocus.ca/studyfinds-how-cells-reverse-tissuedamage-caused-by-heart-attack/

Body’s healing mechanism reduces radiotherapy efficiency: U of A team

David Brindley (centre) led a team of University of Alberta researchers, including Xiaoyun Tang (left) and Guanmin Meng, that discovered the irradiation of breast fat enables cancer cells to survive. (Photo by Melissa Fabrizio)

A team of scientists and researchers from the University of Alberta have found that the body’s normal process of healing itself may enable cancer cells to survive radiotherapy.

Breast cancer patients typically undergo 25 daily doses of radiotherapy after surgical removal of a tumour in order to make sure that all breast cancer cells are killed, according to David Brindley, a professor of biochemistry and U of A and a member

of the Cancer Research Institute of Northern Alberta.

During treatment, he said, the adipose tissue releases autotaxin. Autotaxin is kicks off a wound-healing response.

Unfortunately, “this response ends up protecting the remaining cancer cells, allowing them to survive and avoid destruction,” said Brindley.

The study was published in The FASEB Journal. This researcher

was supported by grants from the Canadian Cancer Society Research Institute and the Canadian Breast Cancer Foundation.

As part of the study, Brindley and his fellow researchers exposed rat and human adipose tissue to radiation doses similar to levels patients would experience during radiation therapy, according to a report by Ross Neitz, of the U of A news team.

The team found that irradiation bumped up autotaxin production as well as a inflammatory woundhealing response.

“Cancer cells adopt a variety of strategies for avoiding the immune response in the body,” Brindley.

“If we can block the autotaxin response, we think the body would then be more able to use its own immune system to attack residual cancer cells and to eliminate them, particularly when they are already damaged.”

The team is now experimenting with an autotaxin inhibitor. Their aim is to counteract the wound-healing process which is impeding radiotherapy’s effects.

By striking at the autotaxin, the team is focusing on a target that is independent of the characteristics and mutations of the tumour, said Brindley. He

said he is hopeful that the treatment they are developing can be used on all kinds of breast cancer.

Brindley added that the strategy can be used to treat other types of cancer such as thyroid cancer and glioblastoma and to improve the efficacy of chemotherapy.

The team believes the same strategy can be used to improve the efficacy of chemotherapy. They hope to soon move their work into rodent animal models to provide further evidence that the approach works.

“The advantage of attacking the autotaxin as a target is that it is independent of the characteristic and mutations in the tumour. We are not targeting the cancer cell itself, but its environment, which should be similar in different tumours. We’re hopeful that our treatment will be applicable to all kinds of breast cancer and not just a particular subtype.”

The team hopes to soon move their work into rodent animal models to provide further evidence that the approach works.

To see this story online visit https://biotechnologyfocus.ca/ bodys-healing-mechanism-reducesradiotherapy-efficiency-u-of-a-team/

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Laboratory Focus August/September 2017

Germany’s IDT Biologika to build vet biologics plant in Canada German pharmaceutical company IDT Biologika is doubling down on it animal health presence in North America with the acquisition of a new facility in Ontario. The company is working with Gallant Custom Laboratories of Cambridge, Ont. to in converting the recently purchased building into a vaccine manufacturing plant.

“If you hadn’t heard of IDT in Canada before, you will now,” said Jackie Gallant, founder, and president of Gallant Custom Laboratories.

“This new facility will be a great boost for Canadian animal health and the local economy,” said Gallant, who oversees animal health R&D and customer relations in Canada. “Additionally, it offers tremendous expansion possibilities in the future to help us continue to meet the demands of a strategically important, growing market in the Americas.”

Gallant, which runs an autogenous veterinary biologics facility in Cambridge, was purchased by IDT in 2015.

The company is now helping IDT in its plans to gain a more solid presence in the North American animal health market. As part of this plan, the expansion of Gallant’s operations in its Cambridge laboratory will begin as early as summer 2018.

IDT also purchased last week, a building in Cambridge from Com Dev. Ltd. The building will be converted into a state-of-the-art vaccine manufacturing facility.

“We intend to raise the bar for manufacturing technology and innovation, capacity, and development of veterinary biologics in Canada,” said Andreas Kastenbauer, managing director of IDT and head of the company’s global Animal Health Division. “As we continue to expand our footprint across the Americas, veterinarians, farmers and government agencies in Canada and in the region are sure to reap important benefits from the breadth and depth of our capabilities that will emanate from this vaccine manufacturing hub in the years to come. “ IDT wants to become the region’s leading autogenous and commercial vaccine manufacturer

Two years ago, the company snapped up Gallant and launched a mission to establish Canada’s only “vaccineonly” animal health company.

Following its Gallant acquisition, IDT purchased Ridgeway Biologicals Ltd, a UK-based supplier of autogenous vaccines for produc-

tion animals and aquaculture.

With that move, IDT formally established its Animal Health Americas business unit.

The nearly 32,000-square foot facility which IDT bought, will support a significant increase in IDT’s production capacity and innovative and efficient processes for the

commercial production of animal health vaccines, including antigen production, blendingfilling-packaging, storage, a clean room lab, offices and meeting areas, and bacterial research that meet highest quality requirements.

Automation, as well as cutting-edge equipment and

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news computing capabilities, are being considered in construction and installation plans.

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Appointments

Vancouver’s Zymeworks Inc. has appointed to its board of directors Dr. Natalie Sacks, a respected clinician, and current chief medical officer of the California-based cancer immunotherapy

Dr. Natalie Sacks

company Aduro. Zymeworks is a clinical-stage biopharmaceutical company focused on development and commercialization of next-generation multi-functional biotherapeutics specifically for the treatment of cancer. With the appointment of Sacks, Noel Hall will be stepping down from Zymeworks’ board of directors. “The addition of Dr. Sacks to our board of directors further strengthens the diverse expertise of our board, especially for the clinical development of our therapeutic programs,” said Dr. Ali Tehrani, Zymeworks’ president, and CEO. “Dr. Sacks brings a breadth of experience in ImmunoOncology and will provide valuable insight to the board and our clinical team. We are very pleased to welcome her to the Zymeworks team.” Tehrani also thanked Hall for his “valuable contributions and commitment to Zymeworks” during his tenure. “I look forward to being part of the Zymeworks family,” said Sacks. “With ZW25 advancing through Phase 1 development, this is an opportune time to join the board of directors and share my expertise with the company.” Sacks has been the CMO of Aduro Biotech since September 2016. Previously, she was vice-president of clinical development at Onyx Pharmaceuticals where she played a key role in the development and approval of Kyprolis, an FDA-approved therapy for the treatment of relapsed or refractory multiple myeloma. Sacks was vice-president of clinical research for Exelixis. She directed the development of a portfolio of small molecules, with responsibilities ranging from IND filings to latestage development, including the late-stage development of Cometriq, an FDA-approved therapy for the

treatment of medullary thyroid cancer. Prior to that, she served as vice-president of clinical development at Cell Genesys, a company focused on the development of cancer vaccines and engineered chimeric antigen receptor (CAR) T cells. Much earlier, she held a variety of research and analytical roles at academic institutions and companies, including Massachusetts General Hospital, Medical College of Pennsylvania, and ICI-Stuart Pharmaceuticals. Sacks received her M.D. from the University of Pennsylvania School Of Medicine, her M.S. in Biostatistics from Harvard University School of Public Health and her B.A. in Mathematics from Bryn Mawr College.

Halifax-based Appili Therapeutics has chosen Sean McBride, a pharma industry veteran who headed GlaxoSmithKline’s commercial and business development department, to lead Appilli’s out-licensing, product in-licensing, and acquisitions push. McBride’s appointment as Appili’s new vicepresident of business development comes at a time when the company is building its pipeline of products aimed at infectious diseases.

“Sean’s experience in international deal-making, along with his expertise in pharmaceutical sales and marketing will be invaluable as we build our balanced-risk pipeline of near-to-revenue opportunities with higher-risk, transformational drugs that can truly change the way we treat infectious disease,” Kevin Sullivan, CEO of Appili Therapeutics, in a statement yesterday. Appili is identifying, acquiring and advancing novel therapeutics for infectious disease. The company has two antiinfective programs, ATI-1501 and ATI-1503, in its pipeline. ATI-1501 is a taste-masked treatment for anaerobic infections that has been granted orphan drug status by the FDA. Appili plans to take ATI-1501 into clinical trials in 2017. Appili’s second product, ATI-1503, is a novel antibiotic with broad potential to treat deadly Gram-negative infections. McBride brings more than two decades of experience within the Canadian pharmaceutical and biotechnology industry. His expertise lies in licensing, purchasing, and divesting assets, in addition to advancing the commercialization of early stage assets and identifying opportunities for growth. Prior to joining Appili, McBride spent 10 years at GlaxoSmithKline Inc. (GSK) serving in many roles of increasing responsibility. Most recently, he

Sean McBride served as head of an entrepreneurial business unit where he negotiated global asset transactions and was responsible for the commercial success of over 40 brand assets. Before joining GSK, McBride served as a director for healthcare agencies conducting commercial and strategic assessments in both Canada and the U.S., and also served as director of marketing with Roche Pharmaceuticals. “This is an exciting time to be joining the Appili team as it seeks to take advantage of the many incentives aimed at fighting antibiotic resistance and grow its pipeline of anti-infectives,” said McBride. “There are many players including government, non-profit, and for-profit organizations with an interest in infectious diseases and I look forward to bringing my experience working with these organizations, and contributing to the company’s future success.”

The BC Bioenergy Network (BCBN) board of directors announced the appointment of Dr. Scott Stanners as executive director. Stanners brings almost a decade of experience with BCBN. Among the positions he held at the organization were: director of research, director of business development, technology, and innovation, and acting executive director.

BCBN is a provincially-funded association supporting the bioenergy sector in British Columbia. “We are pleased to congratulate Scott on his

Dr. Scott Stanners

appointment as executive director,” said Brent Sauder, chair of the board. “His years of experience with BCBN will be incredibly beneficial in defining a new direction for BCBN and advancing the use of bioenergy in BC and beyond.”

Before working at BCBN, Stanners held key advisory positions in the biotechnology sector in Canada and Australia with government, private organizations, and industry associations. He has a B.Sc. from University of Calgary and a Ph.D. and Graduate Certificate in Innovation and Enterprise from The University of Sydney, Australia. Stanners is a board member and director of memberships of the Canada, Australia & New Zealand Business Association and board member and president of the Pacific Energy Innovation Association. Scott has managed the West Coast Bioenergy Guild since 2010. enGene Inc., a biotechnology company focused on the development of a proprietary oral gene therapy platform, today announced the appointment of Steve Gannon as an independent director on its Board of Directors. Gannon will also serve as the chairman of the company’s audit committee. He brings to enGene a wealth of financial and

Steve Gannon operational expertise and close to 30 years of leadership experience in the biopharmaceutical industry. He was chief financial officer, senior vice president of finance and treasurer at Aptalis Pharma Inc. until February 2014, when it was acquired by Forest Laboratories Inc. “Mr. Gannon’s impressive track record in corporate finance, business development and strategic transactions in the healthcare sector, will be extremely valuable to enGene as we embark on our next phase of development in advancing our game-changing Gene Pill platform to clinical testing and expanding its application in new indications,” said Dr. Anthony T. Cheung, president and CEO of enGene.

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Laboratory Focus August/September 2017

Feature B y A n ge l a S t ut z

How to Measure pH In Protein-Containing Samples Summary Measuring pH in protein-containing samples can be challenging as protein can foul both the pH sensing glass and classical ceramic junctions.

In order to obtain accurate pH readings, both of those components must be maintained in optimal condition.

Protein Fouling of Sensing Glass In any aqueous solution, acid is present in the form of hydronium ions.

The sensing membrane in a pH sensor is specially designed to interact with these hydronium ions to generate a voltage potential, which is then converted into a useable pH value. In order for this interaction to happen, the sensing glass of the sensor must be free from contamination, such as protein residues. Any contamination present on the glass will limit the surface area available for interaction with hydronium and slow the reaction of the sensor.

A slow sensor is more than just an inconvenience. The pH meter to which the sensor is connected needs to find a mathematical endpoint

Figure 1

based on the change in millivolt signal per a time unit. Since the change in millivolt signal is derived from the interaction of the hydronium in solution with the sensing glass of the sensor, protein contamination can have an effect on the value, and introduce measurement error. When a sensor is free of protein residue the voltage potential changes very quickly over time as it acclimates to the new hydronium ion concentration. After a few seconds, this change in potential per second decreases, and when it decreases below the “stability criterion” for the meter, the final pH value is captured.

Due to the decreased available surface area of the sensing glass, the initial change in mV potential per unit time is smaller. In the same manner as the clean sensor, the contaminated sensor will also produce smaller changes in millivolt potential with time as the system reaches equilibrium. However, whether the sensor reacts quickly or slowly to a change in solution pH, the pH meter has the same “stability criterion.”

Creation of potential at glass membrane

A clean, residue-free sensor

Protein Blockage of Ceramic Junctions Just as with the sensing glass of the sensor, the junction is susceptible to protein fouling. A classical ceramic junction is a frit located just above the

sensing glass of the sensor. The frit is comprised of small pores, designed to allow liquid electrolyte to flow out of the sensor and into the sample. The flow of electrolyte is critical to obtaining an accurate pH reading – it pro-

Figure 2

Response time of a clean vs. a contaminated sensor. Clean membrane (blue) pH=6.026, Endpoint Time: 84s Contaminated membrane (green) pH=6.022 Endpoint Time: 374s

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August/September 2017 Laboratory Focus www.laboratoryfocus.ca

feature

Figure 3

duces a stable reference potential and closes the circuit of the sensor.

Without steady electrolyte flow into the sample, error in the reading is unavoidable.

Liquid electrolyte is a concentrated salt solution. Often, when protein solutions are exposed to brines, the protein will precipitate to form a solid. When a solution is subjected to pH measurement, a salt gradient is formed, with the highest concentration of salt being located at the pH sensor’s junction. This makes protein precipitation in the sensor’s junction a likely scenario. As proteins precipitate in the small pores of a ceramic junction, electrolyte flow is slowed and eventually halted, introducing error into the pH reading.

How to Remove Protein Contamination Left to right: clean junction (white “dot”) is visible in front of black temperature probe and contaminated junction (black “dot”)

The InLab Max Pro-ISM is similar in design to the InLab Routine Pro-ISM, with the introduction of a fixed sleeve junction instead of a ceramic frit.

Protein contamination can be removed from both the pH sensing glass and the ceramic junction. Sensors contaminated with proteins should be cleaned by immersion in a solution of 5% pepsin and 0.1 mol/L hydrochloric acid for several hours.

The solution can digest the protein deposits and leave both the junction and the sensing glass clean. A proactive approach to sensor maintenance can prevent the buildup of proteins in critical components of a pH sensor.

After measuring concentrated protein solutions, a 15 minute soak in the same pepsin/hydrochloric acid solution will clean the sensing glass and junction. This maintenance routine will contribute to more accurate results throughout the life of the sensor.

Finding the Right Sensor Mettler Toledo offers sensors designed for use in biological applications. Susceptibility of sensors to protein fouling can be significantly reduced with the right combination of sensing glass and junction.

InLab® Routine Pro-ISM InLab Routine Pro-ISM is the standard pH sensor used in many labs and employs a ceramic frit. With the correct cleaning (Pepsin/HCl), this sensor provides very good results in proteinaceous samples.

InLab Max® Pro-ISM The InLab Max Pro-ISM is similar in design to the InLab Routine Pro-ISM, with the introduction of a fixed sleeve junction instead of a ceramic frit. The electrolyte flow is fast, the junction is difficult to block, and the sensor is still very easy to handle.

InLab® Science Pro-ISM The InLab Science Pro-ISM pH sensor uses A41 sensing glass, which is designed to resist protein fouling and is ideal for biological media. The sensor also employs a moveable glass sleeve junction instead of a ceramic fritted junction. The glass sleeve junction can be easily rinsed, and cannot be blocked by precipitated proteins.

Figure 4 Angela Stütz has a degree in biology. She has worked with MettlerToledo for nine years in product management for electrochemical instruments.

(Left to right) InLab Science Pro-ISM (movable glass sleeve), InLab Max Pro-ISM (fixed glass sleeve) and InLab Routine Pro-ISM (ceramic frit)

To see this story online visit http://laboratoryfocus.ca/how-to-measure-ph-in-protein-containing-samples/

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Laboratory Focus August/September 2017

B y J . Tat e G o d f r e y, CEcD , E x e cu t i v e D i r e ct o r, I nd us t ri al As s et Manag ement Co unc i l ( IAMC)

Benefits of Highly Flexible Biopharma Facilities

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nnovation and breakthrough are biopharma watchwords. But for an industry built on a foundation of constant change, there’s a clear disconnect between the mission-critical, continuous drive for something new and the inflexible facilities that house operations. Today’s biopharma facilities are built for today’s use, with little thought about tomorrow.

What’s the typical approach when there’s a process innovation or a new drug coming to market? Start over in a brand-new building, with permanently embedded equipment designed around a specific process.

This approach is expensive and unsustainable. New life sciences production facilities can cost anywhere from $500 million to upwards of $1 billion. They can take years to bring online, given the extensive planning, permitting, construction, and qualifying required. With the rapid pace of discovery, innovation and change in

Feature

the industry, these buildings could be close to obsolescence from the moment the doors open.

However, retooling or reconfiguring this new facility, with its permanent equipment and structural barriers, could be too expensive, too time consuming and too disruptive.

The result? Rather than contributing to company goals, the facility begins life by putting the company at a competitive disadvantage, making it more difficult to respond to competitive pressures, changes in demand, or technological advances that could improve operational efficiency and reduce costs.

White paper proposes alternative approach A new white paper from the Industrial Asset Management Council (IAMC) and the Society of Industrial and Office Realtors (SIOR) proposes a way forward that upends the traditional thinking about designing biophar-

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August/September 2017 Laboratory Focus www.laboratoryfocus.ca

feature Facilities implications include: colocation of central lab, pilot, and production for increased collaboration; smaller footprints; smaller batch processing; agile facilities capable of rapid change-outs, integration of next-generation equipment; and production of multiple products using multiple processes.

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Cloud-based R&D – Early research and discovery experimentation will always require a certain amount of hands on bench work, however, as the research matures, cloud-based experimental platforms allow for high throughput parallel processing across a range of variables such as samples, acidity, and temperature. Cloud technologies enable researchers to run experiments repeatedly with the exact same parameters.

Facilities implications include: Central lab linked to CROs around the world; fewer benches; colocation of central lab with pilot and production for increased collaboration.

Universal manufacturing space with minimal structural barriers

What we used to do in a 600,000 square foot plant we’re now doing in a 200,000 square foot plant

ma facilities around a single product using today’s processes. “Rx for Change: The Flexible Biopharma Facility of the Future” outlines creative and practical suggestions on how to extend the lifecycle of future biopharmaceutical facilities so they can be reconfigured quickly, efficiently, and cost-effectively for rapid scaleup and scale-down, technological change, scientific breakthroughs, and process innovation.

In an informal, anecdotal survey conducted by the DesignFlex2030 design team, biopharma facilities users confirmed what the team had suspected: that the evolution in the biopharma value chain will impact future facilities decisions.

The industry has often responded by building separate, stand-alone facilities with permanently installed equipment to produce a single product. “When demand wanes or the outdated facility has run its course, it is shuttered,” according to author of the white paper, Anne Moline.

“So, companies are left with legacy facilities that they wind up selling for pennies on the dollar.”

Disruptive industry trends Here are some of the top disruptive industry trends and pressures that will affect the future design of life sciences facilities, as identified by facilities users interviewed by DesignFlex2030 team:

1

Process, equipment, and technology innovations – Increased reliance on single use/disposable production, shift to continuous processing, and smaller footprint.

“What we used to do in a 600,000 square foot plant we’re now doing in a 200,000 square foot plant,” says one life sciences company real estate advisor.

Widespread use of 3D/4D printing for identical cell lines will likely replace the need for breeding colonies of live animals for research and for mammalian cell culture manufacturing— thus reducing vivarium space needs. Facilities implications of the innovation trend include: Open and flexible space; portable, easy-to-install, self-contained processing units; flooring that can support heavy loads; plug-and-play utilities connection; decentralized, segregated HVAC and controls for production of multiple products and a variety of processes

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New therapy discoveries, changes in drug development, fasttracked regulatory approvals & personalized medicine – The increasing work in personalized medicine, means a shift from large manufacturing process to small-scale lab processes. Regulatory authorities will have local outlets to fast-track new molecules, meaning a shorter time to market.

Among the many practical suggestions, the paper proposes a facility design that is essentially a shell and a wide open universal manufacturing space inside. By minimizing use of structural columns, open space is maximized for total flexibility. Prefabricated modules, self-supported with their own mechanical capabilities, slide in and slide out. This allows for easy manipulation of the interior to accommodate process changes and technological advances. Individual units can work independently or combined, so internal spaces can be altered with minimal construction disruption.

Stainless steel tanks for upstream and downstream purification are anchored to skids with plug-and-play power amplification units for ease of removal and replacement within modules. Self-contained individual rooftop HVAC units enable better access for control, monitoring, and repair.

Modulization enables co-location benefits Additional modules can house filland-finish units that can be colocation on site or shipped anywhere in the world, depending on market demand — and on changes in incentives and tax regimes. Other on-site modules can house pilot production of new drugs in the clinical trial stage, allowing for cross-team consultation to optimize future production processes. Colocated lab areas — also modulized — are designed for maximum flexibility as well, en-

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Laboratory Focus August/September 2017

feature

WORLD FORUM FOR MEDICINE 13 � 16 NOVEMBER 2017 DÜSSELDORF GERMANY www.medica-tradefair.com

LABMED FORUM

Additional modules can house fill-and-finish units that can be colocation on site or shipped anywhere in the world, depending on market demand — and on changes in incentives and tax regimes. abling shared core instrumentation among other benefits.

The configuration allows for massive ramp up for a single blockbuster drug. It can produce anything from monoclonal anti-bodies to small molecule, oral solid dosing — in massive quantities or on a small scale. Manufacturing of multiple products can take place at the same time, using both continuous and batch production approaches, depending on what works best.

Focus on disposables in upstream and downstream processes The proposed wide-open design approach supports the growing use of disposables in bioprocessing as reactors become able to accommodate larger-scale capacities—by the year 2030, it’s estimated that they could handle up to 5,000 liters of material.

Large plastic bags store and transport buffers and media in an airtight, dust-free process, connected to reactors via large volume plastic tubing that also gets discarded after use.

A “future-proof” facility Overall, this non-traditional plan enables adaptability and adjustment, allowing for new job roles, different kinds of collaboration, innovation, discovery, and advancement — yielding a “future-proof” facility.

www.medica.de/MLF2

The world of laboratory technology and diagnostics at a glance: • all innovations

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• trends in clinical analysis technology • excellent knowledge

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• innovative solutions for your daily practice and more If you want to see it all, know it all and experience it all, come to the largest world forum for medicine in Düsseldorf!

The exhibitors with laboratory technology and diagnostics present themselves at MEDICA 2017 in hall 3 and modern temporary halls 3a and 18.

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IAMC is the leading association of industrial asset management and corporate real estate executives, their suppliers, service providers and economic developers.

SIOR is the leading professional office and industrial real estate association that promotes and funds programs that advance the real estate profession.

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Canadian German Chamber of Industry and Commerce Inc. Your contact: Stefan Egge 480 University Avenue _ Suite 1500 _ Toronto _ Ontario _ M5G 1V2 Tel.: (416) 598-1524 _ Fax: (416) 598-1840 E-mail: messeduesseldorf@germanchamber.ca For Travel Information: LM Travel /Carlson Wagonlit Tel: 1-888-371-6151 _ Fax: 1-866-880-1121 E-mail: ahoule@vovagelm.ca

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Using 3D printing to make lab equipment on the cheap The DIY microscope called FlyPi cost $150 to build and can be used as a medical diagnostic tool and teaching aid

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aboratory equipment typically cost anywhere from the thousands to hundred thousand dollars. However, a neuroscientist and his collaborators have created an imaging and microscope system for fluorescence microscopy and optogenetics which only cost a whopping €100 or about $150.

The DIY lab equipment called “FlyPi” microscope designed by Dr. Tom Baden, a neuroscientist at the U.K.’s University of Sussex, and his colleagues, has been demonstrated to be a useful medical diagnostic tool and teaching aid at a neurogenetics course held in several African universities.

“Taken together, the low cost and modular nature, as well as fully open design of FlyPi, make it a highly versatile tool in a range of applications, including the classroom, diagnostic centres, and research labs,” according to the paper authored by Andre Maia Chagas, Lucia L. Prieto-Godino, Aristides B. Arrenberg, and Baden.

Their work was recently published in the journal PLOS Biology.

The technology is based on a 3Dprinted mainframe, a bare bones microcomputer called the Raspberry Pi which retails for around $48 in Canada, a high-definition camera, and Arduino-based optical and thermal control circuits.

Actually, the FlyPi can be assembled for well under $150 with optional modules for light-emitting diode (LED)-based fluorescence microscopy and optogenetic stimulation as well as a Peltier-based temperature stimulator for thermogenetics.

The complete version with a full complement of modules will set you back approximately $295 or “substantially less if the user is prepared to shop around,” according to the authors. All functions of FlyPi can be controlled through a custom-written graphical user interface.

What would you use it for?

Put together from readily available off-the-shelf mechanical, optical, and electronic components, the FlyPi can be used to conduct a variety of standard laboratory functions from optogenetics, the use of light to control

cells, and studying the behaviour of small animals such as fruit flies and zebrafish larvae.

The inspiration for the FlyPi came to Baden and Chagas when they were working in Tanzania and found it very hard to find suitable laboratory equipment.

The local universities had microscopes but there always seemed to be more users that there were microscopes for them to use.

The duo ended up doing the rounds of cheap electronics stores in search of equipment. They discovered that low-cost LED lights, Web cams and other items could be cobbled together to build an alternative to more expensive lab microscopes.

Through the development of FlyPi, Baden, Chagas, and Godino have also branched out to teaching 3D print-

Image courtesy of Tom Baden ing, programming and lab equipment building in universities in Kenya, Uganda, Ghana, Nigeria, South Africa, Sudan, and Tanzania.

While computer programmers have open-source software and exchange code that is freely available to anyone, the FlyPi team is propagating the practice of “open labware,” according to the CBC News.

“It’s a community driven effort,” said Baden. “We stick it online, people say, ‘you did this badly.’ It makes things faster and better. The more people do it the better designs we get.”

The group admits their creation has some limitations. One obvious limit of FlyPi is spatial resolution. “The system currently resolves individual human red blood cells but narrowly fails to resolve malaria parasites within,” the paper said. “…Similarly, photon catch efficiency of the CCD sensor could be improved by use of an unfiltered (monochrome) chip.”

But the FlyPi is a work in progress.

Its makers expect further development to take place as researchers and educators integrate their own features into the design.

“Clearly, the current FlyPi only scratches the surface of possible applications,” the team said.

To see this story online visit http://laboratory focus.ca/using-3d-printingto-make-lab-equipment-onthe-cheap/ Image courtesy of Tom Baden

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Laboratory Focus August/September 2017

Pharma Notes Shire Pharma Canada ULC, said the company’s Onivyde (irinotecan liposome for injection) has been approved for the treatment of metastatic adenocarcinoma of the pancreas, in combination with 5-fluorouracil (5-FU) and leucovorin (LV), in adult patients who have disease progression following gemcitabine-based therapy. About 60 per cent of pancreatic cancers are detected at a late stage, which significantly contributes to its poor prognosis. It is estimated that 5,500 Canadians will be diagnosed with pancreatic cancer in 2017, but only 50 per cent of those are expected to survive beyond about four months after diagnosis. Onivyde is the first and only approved treatment option for this patient population which has no universally accepted standard of treatment until now. Based on the NAPOLI-1 trial, Onivyde has been shown to extend patients’ overall survival by two additional months.

Onivyde’s active ingredient irinotecan is encapsulated in a longcirculating liposomal form. Through this unique delivery system, Onivyde prolongs drug circulation and may lead to increased accumulation of the drug and its active metabolite (SN-38) in the tumour. Studies have suggested that encapsulation helps to improve delivery of irinotecan to tumors, such as metastatic pancreatic cancer.

ImmunoPrecise Antobodies of Victoria, B.C. announced that it has signed an agreement with U-Protein Express BV, which paves the way for ImmunoPrecies to acquire U-Protein. “Completing the acquisition of U-Protein will be an excellent strategic fit for ImmunoPrecise as it is complementary to our expertise in custom monoclonal antibody production as well as offering an exceptional opportunity to expand our business into the European marketplace,” said Tom D’Ozario, president and CEO. “The combined company will be able to offer an expanded portfolio of services, further diversifying our revenue base and achieve our strategic, long-term business objectives.” Under the terms of the definitive agreement, the ImmunoPrecise acquires all of the issued and outstanding shares of U-Protein for $10,108,400. Approximately $4,047,390 will be paid in cash on closing, approximately $3,030,498 will be satisfied by the issuance of approximately 3,030,498 common shares of the ImmunoPrecise, on closing, and approximately $3,030,498 in deferred payments over a three-year period.

Microbix Biosystems Inc., an innovator of biological products and technologies, announced the execution of an agreement to supply an existing long-term customer with an increasing quantity of Microbix’ viral antigen products over the next five years. Both parties have the option to extend that term. Sales from the agreement are expected to total $25 million, with approximately $10 million being new business.

Microbix infectious disease antigens are incorporated into diagnostic

tests used by laboratories and hospitals around the world. The customer is a major global diagnostics company with growing sales of infectious disease tests that require more antigen supply. The agreement also expedites the conversion to product derived from Microbix’ new bioreactor – replacing its roller-bottle processes. The bioreactor process is expected to provide enhanced manufacturing capacity and immediate economic benefits for both Microbix and its customers.

The companies have also agreed to explore additional opportunities to collaborate. “Our customer is a leading global diagnostics producer and our long-term partnership with them has been rewarding for both companies. We’re delighted to expand this key relationship through this agreement, which also demonstrates the growing demand for Microbix’ products,” said Phil Casselli, senior vice-president of business development at Microbix.

Give kids like Greer every chance to get better.

PUT YOUR MONEY WHERE THE MIRACLES ARE.

GREER 6 YEARS OLD

Greer’s remarkable recovery from a horseback riding accident was helped by community donations. Children’s Miracle Network® dollars provided a private PICU room and also purchased the pediatric CT scanner which analyzed her traumatic brain injury. Showing no fear of the animal that crushed the right side of her face, Greer is happy to be “back in the saddle” and now wears a special helmet for added safety during her weekly riding lessons.

Children’s Miracle Network raises funds and awareness for 170 member hospitals, 14 of which are in Canada. Donations stay local to fund critical treatments and healthcare services, pediatric medical equipment and research. Its various fundraising partners and programs support the nonprofit’s mission to save and improve the lives of as many children as possible. Find out why children’s hospitals need community support, find your member hospital and learn how you can Put Your Money Where the Miracles Are, at childrensmiraclenetwork.ca and facebook.com/CMNHospitals.

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August/September 2017 Laboratory Focus www.laboratoryfocus.ca

New Products Liquid biopsy

Exosome Diagnostics’ MedOncAlyzer 170 is the first liquid biopsy pancancer panel that simultaneously interrogates exosomal RNA (exoRNA) and circulating tumor DNA (ctDNA) in a single assay, according to the liquid biopsy solutions company.

The MedOncAlyzer 170 is a targeted panel for tumor profiling that identifies clinically actionable and functionally important mutations across multiple cancer types starting from a small volume (≥ 0.5ml) of patient blood or plasma.

“The MedOncAlyzer is the only cancer panel on the market that interrogates information on both RNA and DNA, giving it a higher sensitivity compared to ctDNA assays when profiling early stage and late stage cancers in plasma,” said Johan Skog, chief science officer of Exosome Diagnostics. “ctDNA-only solutions are seeing their most accurate measurements in late stage cancers.”

The primary drivers of ctDNA release into the bloodstream are apoptosis and necrosis of tumor cells. However, Skog said existing solutions that rely on ctDNA alone are building a profile of the tumor that is biased towards consequences of cell death.

“Exosomes, in contrast, are actively released by living cells including viable tumor cells,” Skog explained “The MedOncAlyzer, with its unique ability to co-isolate RNA and DNA, is balanced to produce accurate, highly sensitive identification of rare variants through all stages of disease progression and treatment, including RNA variants that cannot be seen on ctDNA.”

Web: www.exosomedx.com

Ellipsometers Horiba Scientific, a maker of has launched Uvisel Plus, a modular ellipsometer which is designed to measure thin film samples faster, and more accurately than previous models. The Uvisel Plus incorporates Horiba’s FastAcq technology.

FastAcq is based on a new electronic data processing and high-speed monochromator which enables it to take sample measurements from 190 to 2100nm to be completed within 3 minutes, at high resolution. The ability to continuously adjust the spectral resolution along the measurement range enables to scan a sample smarter and faster. Uvisel Plus also introduces a new calibration procedure, delivering faster performance and accuracy. The new ellipsometer has no rotating elements and no additional components in the optical path. Designed for enhanced flexibility for thin film measurements, the Uvisel Plus offers microspots for patterned samples down to 50µm, a variable angle from 40 to 90°, an automatic horizontal mapping stage and a variety of accessories, making it scalable to meet all of your application and budget needs.

Web: www.horiba.com/scientific/products/ellipsometers/spectroscopicellipsometers/uvisel/uvisel-plus-640

Sample preparation kits Cole-Parmer,a manufacturer of laboratory equipment, has launched the Arcis Sample Preparation System can extract DNA and RNA extraction. The kit is designed for carrying out downstream processes, such as PCR/qPCR and sequencing, in just three minutes. It is ideal for use with Cole-Parmer’s Delta Seek reagents and Techne or PCRmax PCR and qPCR hardware systems. Existing sample preparation kits currently require laborious washing, heating and centrifugation steps that typically take 40 to 90 minutes to extract DNA or RNA from a sample. The Arcis DNA Prep Kit requires two simple steps that are completed in just three minutes, to provide high quality, PCR-ready templates with no need for additional laboratory equipment such as centrifuges or hot blocks.

Web: www.arcisbio.com/technology

Pipette accessories Picking up the wrong pipette looks like a set-up for a scene in a comedy but could mean real trouble in any lab. Mettler Toledo hopes to solve the wayward pipette problem with a new stand that helps technicians keep track of their pipettes. The Rainin SmartStand, is a highly scalable pipette asset management system that helps labs and lab managers proactively handle compliance and save time on recordkeeping and reporting.

By reading the RFID chip in every Rainin XLS and XLS+ pipette, the SmartStand transforms how labs manage their pipettes. When a pipette is placed in one of SmartStand’s four holders, the color LCD screen instantly displays its current status in a clear visual language: green is “good,” yellow indicates that service is required soon and red signals that the pipette is beyond its service or calibration date. Remove a pipette from the stand and the color screen switches to a more detailed view of its service and asset record. “By leveraging the data that’s already stored on the pipette’s RFID chip, we’ve simplified how lab managers track service data and assure day-to-day compliance,” said Sicco Drion, product manager of SmartStand. “With SmartStand, service data and calibration status are readily apparent every time a user picks up a pipette. In addition to pushing a pipette’s current status right to the benchtop, the included EasyDirect Pipette Asset Management software simplifies and streamlines how labs manage their pipette data. Whether a lab has 50 pipettes or 500 (or more), EasyDirect is a flexible, infinitely scalable Windows-based pipette asset management tool that can connect to multiple SmartStands simultaneously via Bluetooth. Rather than manually updating a spreadsheet or lab information application (LIMS) every time a pipette is serviced or calibrated, users simply place the pipettes on a SmartStand to transfer new service data from their RFID chips into EasyDirect. EasyDirect maintains a profile with 11 customizable fields for each pipette, so lab managers can assign unique information, such as the user and lab, applications and ID/inventory number, to a pipette and record it to its RFID chip. EasyDirect can also help users find pipettes by identifying which SmartStand they’re hanging on.

EasyDirect also simplifies service by keeping track of which pipettes are due and automatically filling out and printing the appropriate forms. It graphically indicates which pipettes are due for service, making them instantly recognizable. By capturing usage data through the SmartStand, EasyDirect helps lab managers reduce asset costs and eliminate pipettes that are no longer in use.

Web: www.mt.com/ca/en/home/products/pipettes/pipette-management/ smartstand-pipette-charger.html

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Laboratory Focus August/September 2017

Stem thermometres Bel-Art SP Scienceware has cut the cord with its latest laboratory thermometers.

The company’s cable-free calibrated electronic verification lollipop stem thermometers were designed to make the task of verifying temperatures much easier.

“These Lollipop Stem Thermometres are compact, all-in-one units with the display attached directly to the probe instead of with a cable commonly used in electronic verification thermometers,” explains Laura Geenen, director of product management for SP Scienceware.

Cabled electronic verification thermometers are useful in ovens and freezers, and other applications that require the temperature to be verified without disrupting the samples’ environment.

However, for applications where the temperature is verified less frequently, the compact, cable-free Lollipop thermometre is the superior choice.

Web: www.belart.com/h-b-frio-temp-calibrated-electronic-verification-lollipopstem-thermometers-for-refrigerators-incubators-and-general-applications.html

HIV test kits People can now test themselves for HIV in the comfort and privacy of their own homes with a new single-use, disposable test kit developed by bioLytical Laboratories. The Richmond, B.C.-based rapid infectious disease test maker has been introducing it INSTI HIV Self-Test in several jurisdiction over the past few months and has recently launched it last week in the Netherlands. The launch in the Netherlands commenced last week with 20 HIV-specialized pharmacies and further penetration throughout the country is expected to all 1,900 pharmacies. Using a single drop of blood, the INSTI HIV Self-Test is more than 99 per cent accurate and provides a result in as little as 15 to 20 minutes. By comparison, it can take several days or weeks to get back test results from a laboratory, the company said. INSTI is an over-the-counter adaptation of the INSTI point-of-care test which has been used by healthcare professionals in Europe for over 10 years. “We saw the need to provide a solution that would empower individuals to take control of their health in a discrete way, and within the comfort of their own home,” said Robert Mackie, bioLytical’s president. “By launching in the Netherlands, we are able to make HIV testing more accessible and to diagnose those unreachable through current programs.” The was launched successively in Belgium, Kenya, and the United Kingdom. It is estimated that one in seven people are not aware that they are infected with HIV. HIV testing is the foundation of the UNAIDS 90-90-90 initiative, which aims that by 2020, 90 per cent of those living with HIV will know their HIV status, 90 per cent of those individuals will be on antiretroviral therapy (ART), and 90 per cent of individuals on ART will be virologically suppressed. Just achieving the first 90 is a major undertaking. As of 2014, of the estimated 2.5 million people in the World Health Organization (WHO) European Region living with HIV, approximately half were not even aware of their status. Amsterdam has made great achievements in the elimination of HIV and is one of the first European cities that have reached the UN targets. In the latest report published by UNAIDS, Amsterdam is 9490-94. With the availability of HIV tests in pharmacies, the Netherlands can strive for 100-100-100.

Web: www.insti-hivselftest.com

New Products Small RNA prep kit Norgen Biotek Corp., a Canadian biotechnology company specializing in tools for nucleic acid and protein purification and stabilization, has launched a new portfolio of product and service solutions for Next Generation Sequencing (NGS) applications.

Leading the list of new releases from the company is its Small RNA Library Prep Kit for Illumina. This kit consists of all the reagents and components required to generate small RNA libraries to be used for next-generation sequencing on an Illumina platform.

This kit has been optimized for low input RNA (0.5-1ng), especially from bodily fluids and liquid biopsy samples such as plasma, serum, blood, cerebral spinal fluid (CSF), urine and exosomes.

The simple and rapid workflow allows for the library to be prepared in less than 5 hours, with no gel purification required for selected types of samples. Norgen has also launched complementary products for Small RNA Library construction including NGS-compatible cel-miR-39 spikein as well as the NGS Library Quantification Kit (for Small RNA-Seq).

In addition, Norgen also offers a wide range of NGS services to the scientific community. These include isolation services, library preparation, sequencing, and bioinformatics. Norgen is working with many clients and has extensive experience working with low concentration clinical samples.

Web: https://norgenbiotek.com/product/small-rna-library-prep-kit-illumina

Lab refrigerators Clinical and laboratory personnel with the need to store vaccines, pharmaceuticals, and other molecular or biological samples safely, have another line cold storage options in the form of a laboratorygrade, under-the-counter refrigerators being offered

by Thermo Scientific. The TSX505 Series is designed to minimize noise and energy consumption.

The company said the series is the only one in its class which uses thermoelectric devices in place of compressor technology. This approach enables variable speed control. The new refrigerators regulate their internal temperatures more effectively to provide ideal storage conditions for the most demanding applications, according to Thermo Scientific.

The Thermo Scientific TSX505 Series uses a compressor-free V-Drive technology which features synchronized temperature management (STeM). Internal conditions are actively monitored and maintained at the desired temperature. This includes constant monitoring of, and adjustments during, door-openings to minimize the negative impact of temperature fluctuations on samples. The V-Drive and STeM provide uninterrupted temperature stability and uniformity throughout the internal chamber. Furthermore, the new TSX505 refrigerators consume up to 37 per cent less energy than other models, translating to an average annual cost reduction of up to 30 per cent. The TSX 505 refrigerators also cut down on the “humming” sound heard by users of other lab-grade refrigerators. Refrigerators in the series operate at a discrete 35 dBA. This means that the unit can be kept in work areas without disturbing personnel, or nearby patients. The new line also uses environmentally-friendly refrigerants in compliance with the U.S. Environmental Protection Agency’s (EPA) Significant New Alternatives Policy (SNAP).

Web: www.thermofisher.com/order/catalog/product/TSX505GA?SID= srch-srp-TSX505GA

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Laboratory Focus August/September 2017 www.laboratoryfocus.ca

U of C Canada Research Chair

pursues novel approach in cancer study When scientists set out to study how cancers function, they typically examine the DNA of the cancer cell. However, one of the University of Calgary’s Canada Research Chairs awardees is taking a unique approach by looking at the DNA’s epigenome instead.

Dr. Marco Gallo, Canada Research Chair (CRC) in brain cancer epigenomics, is concentrated on the study of gene expressions rather than the genes themselves.

He believes that by examining epigenomes – the chemical compounds that can tell the genome what to do – scientists can gain deeper insights into the growth of cancers and how to treat them.

His research focuses on pediatric brain tumours such as medulloblastoma and ependymoma, as well as adult glioblastoma – the most common malignant brain tumour in adults.

Gallo perceives a “paradigm shift” in biology that is pointing researchers “beyond the genome.”

“In essence, what we’ve discovered in our research to date will potentially enable us to perform a new kind of therapy to directly target the epigenome and fix this aberrant DNA architecture,” he said in a recent interview with UToday, the University of Calgary’s online news service, Six Canada Research Chairs were awarded to the University of Calgary in May this year. The Canada Research Chair program is the centerpiece of the government’s national strategy to build up the country’s research and development capabilities.

Apart from Gallo, the other University of Calgary CRC’s are: • Joule Bergerson, who was awarded for her economic and environmental assessments. Her research is guiding energy transitions that will help governments and industry adopt carbon mitigation technologies.

• Nils Daniel Forkert, awarded for applying advances in medical imaging across disciplines. His work is aimed toward more accurate diagnosis and treatment of cerebrovascular and neurological diseases.

• Arthur Kuo, awarded for his ongoing work on extending the understanding of mobility impairments and to develop new rehabilitation technologies.

• Amanda Meli, awarded for her research into the evolutionary adaptations of primates to environmental change.

• Peter Tieleman, awarded for his advanced applications of high performance computing to the understanding of cellular interactions.

Research Chairs in the natural sciences, health sciences, humanities, and social sciences, engage in research that impact our quality of life, and helps the country become competitive in the international arena.

Obtaining CRC status is a tremendous help for Canadian researchers and scientists. “Receiving a CRC is a huge confidence boost for me and the lab,” Gallo said. “We are very grateful for the opportunity to focus our energy and efforts on performing high-level biomolecular research in this great institution.” Gallo’s research is being supported with a Canadian Institute of Health Research Tier 2 CRC fund. That’s in addition to the funding he’s receiving from the Cancer Research Society, Stand Up to Cancer Canada, and the Alberta Children’s Hospital Foundation.

This year, Gallo also became a recipient of the Young Investigator award from the Alliance for Cancer Gene Therapy. The American organization funds innovative gene and cell therapy research.

app review MyCancerGenome

https://www.mycancergenome.org/app/ Track advances in cancer research by with the MyCancerGenome mobile. It’s a free iOS app from MyCancerGenome.org. The application provides information on cancer types, cancer-related genes, and specific cancer-related genetic mutations. In addition, the app provides information on the drug classes, drug targets, and drug names for antineoplastic agents, either FDAapproved or being studied in clinical trials. The neat thing is that it allows you to find groups mutations by cancer type, gene or mutation. You can search groups of drugs by drug class and drug target. Users can save their searches and pages of interest. Information is routinely updated by MyCancerGenome.org

Biotech Jobs

https://play.google.com/store/apps/details?id=com.app_ biotechjobs.layout&hl=en Are you looking to build a career in the biotech field?

Or perhaps you’re already in the industry but are in search of greener pasture? You can learn about the biotech industry, search biotech engineer jobs, biotech sales rep jobs, biotech project manager jobs, biotech marketing manager jobs and more, with the Biotech Jobs App. The Android app developed by AppPasta.com, also allows users to review biotechnology salary information, review the top 100 Biotech employers, watch biotech career videos, and even leave a business card and resume for hiring employers.

BioLegend Flow Cytometry

https://itunes.apple.com/us/app/biolegend-flow-cytometryapplication/id418680717?mt=8 This iOS application provides users with important information about your flow cytometers and fluorochromes. Developed by BioLegends, the app has a spectra analyzer, an antibody usage calculator and timer to help users with their experiments. This free app can be used for flow cytometry, ELISA, immunoprecipitation, Western blotting, immunofluorescence microscopy, immunohistochemistry, and in vitro or in vivo functional assays.

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