Laboratory Focus January 2010

P h ar m ace u tical

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MaRS Innovation and CDRD announce strategic collaboration tion. “By entering into this innovative agreement, we believe the commercial potential of select projects in our pipeline will be enhanced,” he said.

The first joint project arising out of this collaboration involves technology developed by Dr. Paul Fraser (University of Toronto) and Dr. Bruce Verchere (University of British Columbia), who together are investigating amyloid aggregation inhibitors as a novel approach to address the treatment of diabetes.

“As the inventor, I am looking forward to seeing this innovative technology progress even further by combining the extensive medicinal chemistry work of my lab with the diabetes-specific expertise of Dr. Verchere. The support of MI and CDRD will accelerate and augment the development of this program,”

MaRS Innovation (MI) and the Centre for Drug Research and Development (CDRD) have entered into an agreement to collaborate on projects of mutual interest with a goal to advance and commercialize earlystage health-related discoveries.

“We are excited about our partnership with the CDRD as it provides an

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opportunity for the two organizations to augment each other’s strengths, and leverage resources to generate attractive packages for potential partners, thereby supporting both of our organizations’ mandates of commercializing promising academicresearch,” said Dr. Rafi Hofstein, president and CEO of MaRS Innova-

en v iron m ent

R&D News.......................... 1 Pharma Notes..................... 6 Appointments..................... 7 New Products................... 14 Calendar........................... 17 Career Spotlight............... 18

said Dr. Fraser, professor and Diener chair for Neurodegenerative Diseases at the University of Toronto.

“We believe this technology has the potential to be disease modifying and could create a new paradigm for treating Type 2 Diabetes. This partnership allows us to leverage resources and still focus on our core interests and capabilities. Working with MI and CDRD will provide us with project management oversight, funding support, and access to extensive drug development personnel and infrastructure,” said Dr. Verchere, professor and Irving K Barber chair in Diabetes Research at the University of British Columbia. Dr. Verchere is also head of the Diabetes Research Program at the Child & Family Research Institute (CFRI).

The Government of Canada’s Networks of Centres of Excellence program has recognized both MaRS Innovation and CDRD as “Centres of Excellence in Commercialization in Research (CECR)”.

Two highest doses removed from AD251 Phase II trial, lowest dose continues as planned Elan Corporation, plc and Transition Therapeutics, Inc. have notified clinical investigators of modifications to the Phase II study AD201 and open label extension study AD251 for ELND005, a compound being developed for the potential treatment of Alzheimer’s disease.

The AD201 study is evaluating three dose levels of ELND005 compared to placebo in 353 patients.

Patients will be withdrawn immediately from the study in the two higher dose groups (1000mg and 2000mg dosed twice daily).

The study will continue unchanged for patients who are assigned to

the lower dose (250mg dosed twice daily) and placebo groups.

The AD251 study will be modified to dose patients only at 250mg twice daily.

The decision by the companies to take these actions was made in concurrence with the Independent Safety Monitoring Committee (ISMC) following a review of the ongoing ELND005-AD201 study.

Greater rates of serious adverse events, including nine deaths, were observed among patients receiving the two highest doses. A direct relationship between ELND005 and these deaths has not been established.

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January 2010 Laboratory Focus www.bioscienceworld.ca

news New vaccine for Pneumococcal disease receives Health Canada approval Following a Priority Review, Health Canada has approved Prevnar 13 (Pneumococcal 13-valent Conjugate Vaccine LabFocus.fisherbrand.Dec09.pdf (Diphtheria CRM197 Protein))

for children aged six weeks through five years for active immunization against invasive pneumococcal disease, 12/11/09 9:09:53 AM a bacterial infection that can

include meningitis (inflammation of the coverings of the brain and spinal cord), sepsis (bloodstream infection), bacteremic pneumonia, pleural empyema (accumulation of pus in the cavity surrounding

the lungs) and bacteremia (bacteria in the blood).

Prevnar 13 is designed to provide the broadest coverage of any pneumococcal conjugate vaccine. The new Continued on page 3

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January 2010

news

Electric field propels worms to test new drugs A Nobel-winning process for testing new drugs to treat diseases such as Huntington’s, Parkinson’s, and muscular dystrophy is getting an electrical charge.

Researchers at McMaster University have developed a way to propel and direct microscopic-sized worms (C. elegans nematodes) along a narrow channel using a mild electric field. The discovery opens up significant possibilities for developing highthroughput micro-screening devices for drug discovery and other applications.

“This is the first time that worms have been stimulated to move in a micro-channel device in a very precise and directed way,” said Bhagwati Gupta, assistant professor of biology. “It will allow researchers to study in real time how a proposed drug affects neurons and muscles that control motion of a live specimen.”

The research is described in the January 21, 2010 issue of Lab on a Chip, a leading international journal in the field of nanotechnology and bioengineering. The researchers demonstrate movement of the worms forward and in reverse inside a microchannel, guided by the direction of the electric field (electrotaxis).

“The electrotaxis of the worms has the potential to automate what is currently a slow, manual process for drug screening on worms,” said Ravi Selvaganapathy, assistant professor of mechanical engineering. “The system is fairly easy and inexpensive to scale up to conduct rapid screening of tens of thousands of chemicals in worms to identify drug candidates in a cost-effective manner. Such discovery could accelerate clinical trials in people by allowing scientists to focus

only on relevant drugs and would use limited resources more efficiently.”

Currently, researchers observe worms individually under a microscope as they move in a random manner or in a direction forced by pressure. The new development retains a worm’s natural motion and causes no harm to the worm.

A surprising observation was that the response of the worms was dependent on its age and neuronal development. This allows for large numbers of worms to be sorted and handled in an automated manner.

The findings promise to impact other research areas as well. It will allow researchers to study how neurons respond to electricity. It can also be used to fabricate new kinds of devices to handle and manipulate large numbers of worms.

Continued from page 2 vaccine includes the seven strains in Prevnar (4, 6B, 9V, 14, 18C, 19F and 23F) as well as six additional strains (1, 3, 5, 6A, 7F and 19A) responsible for the greatest remaining burden of invasive disease in young children worldwide.

“The approval of Prevnar 13 is a significant step forward in supporting the health of children in Canada,” says Dr. Jim Kellner, head of the Department of Pediatrics for the

University of Calgary and Clinical Department head of Pediatrics for the Calgary Zone of Alberta Health Services. “Prevnar 13 provides coverage of the 13 most prevalent disease causing strains of invasive pneumococcal disease, including serotype 19A, which is increasing in prevalence in Canada and other regions of the world and is often antibiotic resistant.”

In early 2009, Health Canada

granted Priority Review status to Prevnar 13, which is only granted to drug submissions intended for the treatment, prevention or diagnosis of serious, life-threatening or severely debilitating illnesses, conditions where there is no existing drug on the Canadian market with the same profile or where the new product represents a significant improvement over existing products.

Health Canada’s approval of Prevnar 13 was based on a clinical trial program of 13 core Phase III studies involving more than 7,000 children.

Data from Phase III clinical trials support the safety and immunogenicity of Prevnar 13 for the prevention of pneumococcal disease in infants and young children. Data indicated that Prevnar 13 has a safety profile similar to that of Prevnar (7-valent) and can be administered with all routine pediatric vaccines studied.

The recommended immunization schedule for Prevnar 13 in Canada is at ages two, four, six and 12 to 15 months, and the vaccine can be administered at the same time as other regularly administered childhood vaccines.

C. elegans nematodes seen under a microscope.

Photo: McMaster University.

Allon’s davunetide treatment for schizophrenia patients proves promising The results of a Phase IIa clinical trial presented at a major scientific meeting indicate that Allon Therapeutics Inc. lead neuroprotective drug candidate davunetide achieved measurable positive treatment effects in schizophrenia patients with cognitive impairment. Dr. Daniel Javitt, lead study investigator and director of Cognitive Neuroscience and Schizophrenia at the Nathan Kline Institute for Psychiatric Research in Orangeburg, N.Y., said the data supports and augments top-line results released in July, 2009.

“Further evaluation in a large number of patients is necessary and warranted to determine whether davunetide could become the first approved treatment for cognitive impairment associated with schizophrenia,” said Dr. Javitt.

While results and analysis presented indicated the trial did not achieve statistical significance on the primary endpoint, which was the MATRICS (Measurement and Treatment Research to Improve Cognition in Schizophrenia) composite battery of tests, numerical positive treatment effects were seen

in specific tests that measured visual learning and working memory. A change was observed in verbal learning favouring placebo.

As such, the trial achieved a statistically significant positive treatment effect on a secondary endpoint, which was the UCSD (University of California at San Diego) Performance-based Skills Assessment (UPSA) test.

The UPSA scale assesses the functional capacity of skills for daily living and has been recognized by drug regulators as an appropriate co-primary endpoint in patients suffering from schizophrenia-related cognitive impairment.

Trial data also showed that davunetide was safe and well tolerated by patients with adverse events typical of this patient population. The most commonly reported adverse events were headache, restlessness and sedation.

The trial was managed by TURNS (Treatment Units for Research on Neurocognition and Schizophrenia), with substantial financial support from the National Institute of Mental Health (NIMH), part of the U.S. National Institutes of Health.

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January 2010 Laboratory Focus www.bioscienceworld.ca

NEwS An ineXPensive “diPsTick” TesT for PesTicides in foods

Scientists at McMaster University are reporting the development of a fast, inexpensive “dipstick” test to identify small amounts of pesticides that may exist in foods and beverages.

John Brennan and colleagues note in the new study that conventional tests for detecting pesticides tend to use expensive and complex equipment and in some cases can take several hours to produce results. Their paper-strip test is more practical than conventional pesticide tests, producing results in minutes rather than hours by means of an easy-to-read colour-change.

They cite a growing need for cheaper, more convenient and more eco-friendly tests for pesticides, particularly in the food industry.

The scientists describe the development of a new paperbased test strip that changes

colour shades depending on the amount of pesticide present.

In laboratory studies using food and beverage samples intentionally contaminated with common pesticides, the test strips accurately identified minute amounts of pesticides. The test strips, which produced results in less than five minutes, could be particularly useful in developing countries or remote areas that may lack access to expensive testing equipment.

The study was published in ACS’ Analytical Chemistry, a semi-monthly journal. The article entitled: “Reagentless Bidirectional Lateral Flow Bioactive Paper Sensors for Detection of Pesticides in Beverage and Food Samples”, can be downloaded at http:// pubs.acs.org/stoken/presspac/presspac/full/10.1021/ ac901714h?cookieSet=1

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perifosine (KRX-0401), for the treatment of relapsed/refractory multiple myeloma.

Keryx Biopharmaceuticals, Inc. is Æterna Zentaris’ partner and licensee for perifosine in the United States, Canada and Mexico. Perifosine is also out-licensed to Handok in South Korea while Æterna Zentaris retains rights for the rest of the world.

The Fast Track program of the FDA is designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs.

Fast Track designated drugs ordinarily qualify for priority review, thereby expediting the FDA review process.

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eloma to be conducted by our partner Keryx, which we hope will establish perifosine as a novel treatment of this serious condition”, stated Juergen Engel, Ph.D., president and CEO at Æterna Zentaris. “We further believe that this North American clinical development program will also be very useful to support the development and registration of perifosine for the benefit of patients in the rest of the world.”

A Phase 3 trial investigating perifosine in combination with bortezomib (VELCADE®) and dexamethasone for the treatment of patients with relapsed/ refractory multiple myeloma is expected to commence by year-end under a Special Protocol Assessment (SPA) with the FDA. In addition, in September, perifosine had received Orphan-Drug designation in the United States for the treatment of multiple myeloma.

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Laboratory Focus January 2010

news YM Biosciences and NRC-BRI produce new breast cancer drug candidates

Medicago reports positive Phase I results for its avian flu pandemic vaccine nized subjects developed an immune response against the H5N1 virus after the second immunization. A four-fold increase in HI titers from baseline in 58 per cent of subjects was observed in the 20 mcg group. HI titers greater than 1:40 were developed in 50 per cent of the subjects in the 20 mcg group. The H5N1 vaccine also induced the production of antibodies cross-reacting with two other strains of H5N1 Avian Influenza suggesting Medicago’s vaccine potential for cross-protection.

Full results of this trial will be submitted for publication in a scientific journal and will be available in the coming months. Based on these results, Medicago will proceed with a Phase II clinical trial, expected to commence during the first half of 2010.

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Medicago Inc. reports positive interim results from a Phase I human clinical trial with its H5N1 Avian Influenza vaccine candidate. The vaccine was found to be safe, well tolerated and also induced a solid immune response.

“We are very pleased with the results from this study.

This trial was the first ever clinical evaluation of a plantbased Influenza VLP vaccine and shows that Medicago’s vaccine is safe in humans,” said Andy Sheldon, president and CEO of Medicago.

The Phase I study was designed to investigate the safety of the company’s H5N1 alumadjuvanted pandemic vaccine candidate and to provide an initial indication of the immune response. A total of 48 healthy volunteers between the ages 18 to 60 received two doses of either Medicago’s vaccine at doses of 5, 10 or 20 micrograms or a placebo. No serious adverse events were reported during the trial and the vaccine was found to be well tolerated at all three dose levels. Local site reactions were mild and the incidence of systemic side effects was comparable between the H5N1 vaccine groups and the placebo. As planned in the initial design, adverse event monitoring will continue for six months after administration of the second vaccine dose. The trial was conducted at the Vaccine Evaluation Center of McGill University in Montréal, QC, under the supervision of Dr. Brian Ward.

Preliminary results showed that 81 per cent of immu-

YM BioSciences Inc. announced the first results of a collaborative program between YM and the National Research Council of Canada’s Biotechnology Research Institute (NRC-BRI).

Utilizing YM’s IntelliMab™ technology, the program is designed to generate novel antibodies that target cell surface receptors associated with cancer, uniquely optimized to produce efficacy with reduced toxicities. The first successfully designed and delivered products from the collaboration are a number of antibodies that bind to HER2/neu-over-expressing breast cancer cells while minimally binding to HER2 on normal cardiac cells. The lead candidate antibody for conjugation is in the final stages of selection from that number.

“This is a new generation of rationally designed antibodies that bind to HER2/ neu on cancer cells to an extent similar to that seen with trastuzumab (Herceptin®, Genentech/Roche) but are distinguished from trastuzumab by their minimal targeting of HER2 on cardiac cells, which is expected to result in reduced collateral cardiac toxicity,” said David Allan, chairman and CEO of YM BioSciences. “The improved specificity of these anti-HER2 antibodies makes them amenable to conju-

gation with highly potent toxins which would permit the selected IntelliMab anti-HER2/neu conjugate antibody to be an important competitor to TrastuzumabDM1 (Genentech/Immunogen).”

HER2 (also known as ErbB-2, ERBB2), is associated with more aggressive breast cancers. Unwanted targeting of HER2 on cardiac myocytes (heart tissue) has been associated with damage to the heart in up to 28% of patients currently treated with trastuzumab when combined with certain chemotherapies.

Dr. Gregory P. Adams, co-Leader, molecular medicine program, department of medical oncology, Fox Chase Cancer Center commented, “Antibodies with better selectivity for tumor tissue over normal tissues are an important goal for improved cancer therapy.

They may offer improved efficacy over less selective antibodies on their own and their major advantage should lie in the precise delivery of toxic payloads to tumor cells, sparing toxicity to normal tissues.”

The collaborative program is a multi-target, parallel-discovery research project funded by YM and NRC-BRI to develop YM’s IntelliMab™ technology, a proprietary platform for

generating new therapeutic antibodies that are designed to be as effective as, but safer than the current generation of antibodies. Collateral toxicity is an important challenge for numerous antibodies that indiscriminately target receptor in normal tissues as well as in the intended cancer cells. Furthermore, these antibodies are expected to be ideal candidates for delivering potent toxins to cancer cells. Depending on the cancer target selected, IntelliMab™ antibodies will be developed as naked antibodies and/or antibody conjugates. The YM team is led by Mr. Sean Thompson, vice president of Strategic Projects and Corporate Development, who is collaborating with Dr. Maureen O’Connor, Leader of the NRC Genomics and Health Initiative Cancer Program.

The IntelliMab™ platform provides YM with an opportunity for an expanded and valuable intellectual property position in the lucrative monoclonal antibody market. All intellectual property resulting from this collaboration will be owned jointly and commercial rights for drug candidates will be retained by YM. The costs associated with the drug discovery collaboration with NRC-BRI are not anticipated to be material to YM.

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January 2010 Laboratory Focus www.bioscienceworld.ca

Appointments

LAB Research Inc. (LRI) announces the nomination of Mr. Yvan Landry as a new member of its board of directors

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and the resignation of Mr. Richard Lacombe who is stepping down to focus on other professional obligations. As part of the conditions of a Standby Purchase agreement signed at the time of a September 2009 Rights Offering, LRI granted Solidarity Fund QFL the right to nominate two individuals on LRI’s board of directors, including one who may be an employee of the FSTQ. Mr. Landry is a certified management accountant who has spent most of his 25-year career with Solidarity Fund QFL, including the last five years as part of the Fund’s Health Care Group.

Jeff O’Hagan has been named chief executive officer of Sunnybrook Foundation, effective April 1, 2010. O’Hagan is currently the Foundation’s senior vice president of development. In addition to managing all operations, O’Hagan will lead the Foundation to achieve the goals of the $470-million Campaign for Sunnybrook, publicly launched in November. Before joining Sunnybrook in 2007, O’Hagan held senior fundraising roles at University of Western Ontario and St. Mary’s General Hospital Foundation in Waterloo. Prior to his entrée into the fundraising sector, O’Hagan enjoyed a successful career in wealth management and estate services at RBC. Canadian oncology CRO Scimega Research has appointed Dr. Luc Daigneault to the position of director Scientific Affairs. Dr. Daigneault completed his PhD in Molecular Biology at the Cancer Institute of Montreal, Notre-Dame Hospital, in 1991. Over the course of his career, Dr. Daigneault has held several strategic positions of increasing responsibility within the biopharmaceutical industry and was involved in the clinical development of several products in oncology and other indications such as HIV and neuropathic pain.

Baljit S. Chadha has joined the board of directors of Warnex. Baljit Singh Chadha, PC, has significant expertise in international trade, marketing and strategic planning.

He is president of Balcorp Limited, an international trade and marketing firm, which he founded in 1976 and built into a successful company with about $100 million in sales and offices in Montreal, New Delhi and Mumbai. Balcorp has diversified interests in agri-food products, forestry products, minerals and services. He is also a well known

philanthropist and a leader of the Indian community in Canada. He has been a key player in a number of international trade missions and treaty development processes. He also sits on the Board of Governors of Concordia University, has advised the Office of the Mayor of Montreal on Indo-Canadian affairs and has served on the advisory board of the Indo-Canada Chamber of Commerce. In 2003, he was appointed by Prime Minister Jean Chretien to the Security Intelligence Review Committee as well as the Queen’s Privy Council for Canada.

B. Mario Pinto, one of Canada’s leading chemical biologists, has joined Sirona Biochem Corp. scientific advisory board. Professor Pinto is a pioneer in the field of chemical biology having developed novel NMR/molecular modeling protocols for protein structure determination and the study of ligand topographies essential for drug and vaccine design. His work also involves the synthesis of antiviral and antibacterial drugs, bacterial vaccines, and new methods of viral control. He has authored 168 scientific papers, 147 other publications which include books and technical reports, and has numerous memberships and awards, including the 1992 Horace S. Isbell Award from the Carbohydrate Division of the American Chemical Society of which he is a member, the 1993 Merck Frosst Award of the Canadian Society for Chemistry (CSC), the 2002 Bernard Belleau Award of the CSC, and the 2005 British Columbia Innovation Council Frontiers in Research Award. He is also a member of the Royal Society of Canada and is Chair of its Selection Committee for the Rutherford Memorial in Chemistry Medal. He has served as the president of the International Carbohydrate Organization, and serves as the vice-president of the Canadian Society for Chemistry.

PharmaNet Development Group, Inc. announces that Stephen Kasay has joined the company as chief information officer.

In his role, Kasay will have global responsibility for the company’s corporate information technology function including strategy development and execution and optimization of the company’s technology infrastructure, software and data assets. Mr. Kasay has over twenty years of experience providing direction to information technology (IT) departments in global pharmaceutical companies and clinical research

organizations. His accomplishments include the strategic assessment and consolidation of data, the successful implementation of software and infrastructure assets to enhance productivity, the establishment of global IT governance processes, and the development of relationships and communication practices with business partners to continually improve efficiencies and client service.

Afexa Life Sciences Inc. announces the appointment of Jack Moffatt as chairman and chief executive officer of the company, effective immediately. In mid-2007, Mr. Moffatt became an advisor to management and the board of directors of the company. In September 2008 he was appointed to the Board and became its executive chair. The following month he assumed oversight responsibility for the company’s day-to-day operations. With an extensive background in packaged-goods retailing and manufacturing in Canada and the US, Mr. Moffatt has held senior management positions in several industries. He is a former chairman and chief executive officer of The Great Atlantic and Pacific Tea Company, and a past president, Control Brands Division, The Cott Corporation. He also served as president of First National Supermarkets, Ltd. Mr. Moffatt holds an MBA degree from the University of Toronto.

Sirius Genomics, a developer of pharmacogenomic diagnostics, announces that Chris Wagner has been appointed president and chief executive officer, replacing Dr. Brad Popovich. Dr. Popovich will continue as member of Sirius Genomics board and will continue to assist Mr. Wagner and the company with the provision of strategic advice and support.

Mr. Wagner has over 17 years of experience in marketing, sales and business development. Since 2007, Mr. Wagner was vice president of Business Development at Sirius Genomics. Previously, he was with Aspreva Pharmaceuticals as the vice president of Marketing and vice president of Business Development. Prior to Aspreva, Mr. Wagner was with Eli Lilly as an international service employee working in Europe, North America and Asia with positions based in Toronto, Indianapolis and Boston.

Mr. Wagner holds a BSc in Organic Chemistry from the University of British Columbia.

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Laboratory Focus January 2010

Pharma Notes Bioniche Life Sciences Inc. (Belleville, ON) announces the issuance of a number of patents in Japan for its proprietary Mycobacterial Cell Wall-DNA Complex (MCC) composition. These patents have claims related to broad MCC compositions, pharmaceutical compositions and medicament compositions. Japanese patent No. 04335435 entitled, “Composition and Method for Regulating Cell Proliferation and Cell Death”, was issued on July 3, 2009. Japanese patent No. 4215429 entitled, “Hyaluronic Acid in the Treatment of Cancer”, was issued on November 14, 2008 and covers composition claims related to combinations of hyaluronic acid and Mycobacterium phlei DNA (M-DNA), MCC or specified oligonucleotides. Japanese patent No. 4380922 entitled, “Chemotherapeutic Composition and Method”, was issued on October 2, 2009. This patent’s claims relate to medicament compositions of MCC or M-DNA and a chemotherapeutic agent for inhibiting the growth of animal or human cancer cells, including leukemia, lymphoma and melanoma.

Teva Pharmaceutical Industries Ltd. and OncoGenex Pharmaceuticals, Inc. (Vancouver, BC) have entered into a global license and collaboration agreement to develop and commercialize OGX-011, as well as an agreement to purchase shares in OncoGenex. OGX-011 is a cancer therapy designed to inhibit cancer treatment resistance. OGX-011 is ex-

pected to be used as adjunct therapy to enhance the effectiveness of chemotherapy and has shown promising results when added to currently available chemotherapies in several tumor types addressing a significant unmet medical need. Teva and OncoGenex will collaborate on a global Phase III clinical program, with two Phase III clinical trials expected to be initiated

Afexa Life Sciences Inc. (Edmonton, AB) announces the launch of a pilot clinical trial of a new formulation, LIP-01 that has shown promise in reducing blood lipids including cholesterol. The trial is designed to identify the optimum dosing levels for LIP-01.

Dr. Richard Lewanczuk, professor, Endocrinology and Metabolism, University of Alberta is heading the clinical trial research team.

Thirty-nine healthy adults with elevated cholesterol levels will be recruited for the trial, which has been approved by Health Canada and the University of Alberta health research ethics board.

Microbix Biosystems Inc. (Mississauga, ON) announces a marketing and supply agreement with Riso Pharma (Toronto, ON) that guarantees purchases of not less than 50,000 KINLYTIC vials over the next three years. KINLYTIC (Urokinase) is Microbix’ thrombolytic agent for treating pulmonary embolism. Under the terms of the agreement, Microbix will grant Riso exclusive rights to market KINLYTIC throughout the Middle East. Microbix will share in the revenues from KINLYTIC sales in all countries covered by the agreement and Riso will be responsible for all commercialization activities. Microbix expects KINLYTIC sales to commence around mid-year 2010.

in 2010: a Phase III Study for Secondline Chemotherapy in Men with Metastatic Castrate Resistant Prostate Cancer (CRPC) and a Phase III Study in First-Line Chemotherapy for Metastatic CRPC. An additional Phase III Study in First-Line Treatment of Advanced, Unresectable Non-Small Cell Lung Cancer (NSCLC) is intended to be initiated by early 2011.

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January 2010 Laboratory Focus www.bioscienceworld.ca

fEATuRE

sTerisonic™ gxP cell culTure co2 incuBATor TechnicAl rePorT

bY DEEPAK mISTRY, hIROKI buSuJImA AND mAT T SIEbERT1

New Co2 incubator with built-in H2o2 sterilization system integrates UV light, copper-enriched stainless steel construction and unique cabinet design to permit frequent sterilization.

Abstract The value of the laboratory cell culture incubator used in highly regulated research and clinical protocols is directly related to the proportion of incubator uptime vs. downtime in applications where frequent interior chamber sterilization is required or desired. The need for interior sterilization before initiating new applications for in vitro fertilization, stem cell research and regenerative tissue culture is more frequent than longer-term cell culture work. The return on investment favours short labour saving sterilization cycles with validation of the sterilization process for GMP applications.

The use of a hydrogen peroxide vapour (H2O2) atomizer in situ to decontaminate the cell culture CO2 incubator without the use of heat sterilization offers significant advantages in routine clinical and highly regulated research laboratories where costly downtime must be avoided. The combination of a seven-minute H2O2 vapour fog in the chamber, circulated by the incubator airflow blower, followed by exposure to narrow-bandwidth ultraviolet light establishes a thorough antimicrobial impact on all incubator walls, shelves, reservoirs, air plenums, sensors and other interior components without the time and expense of high heat cycles, leaving only small amounts of sterile water droplets as a residual. Because all interior components are designed to remain in the chamber for sterilization during the process, use of a separate autoclave is avoided and the incubator can be returned to service

in less than three hours.

In 2009, SANYO Electric Biomedical Co. Ltd. introduced the Sterisonic™ GxP MCO-19AIC(UVH) cell culture CO2 incubator with H2O2 vapour sterilization. The Sterisonic™ GxP complements the company’s proactive in situ contamination control systems first marketed in 2001. In a layered and orchestrated approach to cell culture incubation predicated on good laboratory technique, the addition of H2O2 vapour to an extensive arsenal of existing contamination control techniques, both passive and active, confronts a wide range of laboratory conditions and culture applications.

The SANYO cell culture solution is based on a series of mutually dependent concentric systems working together to offer the safest, most productive in vitro cell culture environment possible. In addition to H2O2 sterilization, SANYO applies the combination of structural and materials engineering, new infrared sensor technology, self compensating narrow bandwidth ultraviolet light, multi-purpose airflow, intelligent microprocessor control and graphical monitoring into a cell culture system designed to reward good laboratory technique for the most critical and highly regulated applications.

Evolution of H2O2 sterilization

The emergence of H2O2 vapour as a practical sterilization method has been well documented by numerous private and public agencies, and is receiving more attention at the bench

level due, in part, to safety and efficacy when compared to ethylene oxide (EtO)2, 3. In a review of commonly accepted sterilization techniques at the USP Annual Scientific Meeting, 20084 [presentation on Sterilization and Sterility Assurance], H2O2 vapour was categorically added to conventional methods such as chemical, dry heat, filtration, radiation and steam sterilization for consideration in selecting the best technique for the desired application.

As a condensing vapour H2O2 is present in multiple phases simultaneously, requiring validation protocols to be constructed within context of a liquid and gas hybrid. While the efficacy of H2O2 vapour assures sterilization, the wide variation in sterilization process parameters among different products and applications requires that validation protocols associated with the cell culture incubator be ascertained from product-specific research in context with known outcomes in vastly different sterilization procedures.

Because a consensus standard for H2O2 remains to be established, the concepts for general sterilizing agents outlined in ANSI/AAMI/ISO 14937 can be adopted as an appropriate validation strategy, along with other EtO standards that may apply.

Additionally, several companies have obtained 510(k) clearance for the use of H2O2 vapour as a terminal sterilization technique for medical devices.

Therefore, current practices suggest that validation for H2O2 vapour sterilization can be compared to EtO.

Advantages in GMP and GLP Applications Systems and design of the Sterisonic™ GxP incubator support both clinical and non-clinical applications, starting with research and leading into development, manufacturing and quality control. As laboratories work to maintain contemporary tools and technologies in advance of new demands for both commercial and clinical success, selection of the laboratory incubator must include consideration for scalability and compliance. When retrofitting or building a new laboratory, lab planners must anticipate reporting and data logging performance of laboratory incubators heretofore classified as commodity equipment, but now recognized a critical link in the chain of custody for quality management and validation5.

The Sterisonic™ GxP incubator offers significant advantages in complying with GMP and GLP criteria imposed by outside and internal regulatory agencies or process manuals.

• With respect to GMP, the incubator includes relational operating systems and safeguards designed to protect the cell culture or cell expressed product, particularly when associated with direct human application such as IVF, stem cells, regenerative tissue processes

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Laboratory Focus January 2010

Feature to intense scrutiny or regulation.

Removing an incubator from service is a costly distraction that requires significant downtime for the decontamination process, prep before and after, and additional time for the chamber to reach a measured equilibrium suitable for cell culture.

While H2O2 is effective for a complete sterilization required separating protocols, the need for a continued protection during the cell culture process is acute. Following years of research and testing, the SANYO Electric Co., Ltd. introduced the SafeCell™ UV sterilization system. The system is a unique sterilization technology described as Active Background Contamination Control™. This process arrests and destroys contaminants within the incubator chamber, and also compares favorably to high heat sterilization offered by leading industry competitors at 90°C and 140°C.

or autologous cell culture6.

• GLP criteria promoting continuity in technique and preserving the acquisition and integrity of performance data associated with the typical incubator performance as well as the sterilization cycle is accommodated through the integral control and monitoring system, complete with data point logging and archiving, and optional communications for remote or offsite monitoring.

In developing the Sterisonic™ contamination control model, SANYO engineers based their H2O2 design on well-documented efficacy7 of the increasingly popular hydrogen peroxide vapour sterilization technique often used in decontamination of biological safety cabinets, environmental chambers and other enclosures. When H2O2 vapour is deployed in association with the narrow bandwidth ultraviolet light decontamination system already designed into the SANYO incubator, the complete sterilization process is safe, effective and significantly faster than conventional high-heat decontamination solutions.

The Sterisonic™ GxP contamination control system The H2O2 incubator sterilization system in vitro is an extension of the SANYO Active Background Contamination Control™ technique introduced by SANYO Electric Biomedical Co., Ltd. in 2001. Now part of the new MCO-19AIC(UVH) incubator series, the new cell culture CO2 incubator employs an isolated narrowbandwidth ultraviolet (UV) light8 to destroy airborne contaminants in the incubator chamber, as well as waterborne organisms in the humidity water reservoir. Integrated with cop-

per-enriched interior surfaces and components which inhibit the growth of organisms without surface discoloration, the SANYO incubator offers an optimum cell culture environment which protects cultures in vitro, and minimizes frequent chamber cleaning and downtime.

In 2006, comparative testing commissioned by SANYO and performed by a certified independent testing laboratory9 confirmed that the SANYO UV light sterilization process is as effective against bacteria, yeasts and molds as high heat sterilization at sustained temperatures ranging from 90°C to 140°C offered in competitive products. Additionally, the SANYO incubator isolates the UV emission from cell cultures during normal operation to permit sterilization of the internal atmosphere following routine door openings without damaging cell cultures, a process which a heat sterilization technique cannot replicate.

Automatically coordinated processes within the Sterisonic™ GxP cell culture incubator work together to maintain optimum in vitro conditions of temperature, humidity and CO2 control while arresting contamination. When complete sterilization is required, the Sterisonic™ H2O2 sequence offers an important uptime advantage over using high heat or conventional decontamination. The three-hour in situ sterilization sequence returns the Sterisonic™ GxP incubator to service more quickly and with greater efficiency than models using high heat or other decontamination protocols.

In applications that require frequent sterilization between processes, the Sterisonic™ GxP yields a significant advantage in productivity.

Independent test results document the efficacy of H2O2 technique

H2O2 and Ultraviolet Light: The Fastest Combination The H2O2 sterilization process permits quick turn-around of the cell culture incubator from process to process where a complete sterilization is required. Applications include in vitro fertilization, tissue regeneration and other highly specific protocols subject

X

Independent testing commissioned

by SANYO supports the efficacy of the concentric contamination control technique based on H2O2 vapour followed by ultraviolet light exposure to render the H2O2 to trace amounts of sterile water and oxygen. The decontamination of the inner chamber of the incubator

Continuing Education for Chemical Professionals

LABORATORY SAFETY COURSE

2010 6FKHGXOH May 31 June 1, 2010 Toronto, ON

October 4–5, 2010 Calgary, AB

Registration fees

$550 CIC members $750 non-members

$150 students members For more information about the course and locations, and to access the registration form, visit:

www.cheminst.ca/ profdev

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T

he Chemical Institute of Canada and the Canadian Society for Chemical Technology are presenting a two-day course designed to enhance the knowledge and working experience of chemical technologists and chemists. All course participants receive the CIC’s Laboratory Health and Safety Guidelines, 4th edition.

This course is intended for those whose responsibilities include improving the operational safety of chemical laboratories, managing laboratories, chemical plants or research facilities, conducting safety audits of laboratories and chemical plants. During the course, participants are provided with an integrated overview of current best practices in laboratory safety.

Canadian Society for Chemical Technology

10

January 2010 Laboratory Focus www.bioscienceworld.ca

fEATuRE

Passive contamination control benefits Test results comparing InCu SaFe™ copper-enriched stainless steel with conventional copper construction illustrate the passive resistance of InCu SaFe™ interior surfaces against common Mycoplasma contamination.

Conclusion

by hydrogen peroxide gas was verified with no BI (biological indicator) growing as observed in every BI collected from all setting locations inside the chamber. While a proposed ISO standard 11138-610 is under consideration by the association for the Advancement of Medical Instrumentation, standards for the use of EtO have been suggested for H2O2 protocols.

UV sterilization efficacy The SANYO UV system is based upon an isolated, narrow bandwidth (253.7nm) ozone-free ultraviolet lamp interlocked with the incubator door.

The interior is comprised of copperenriched stainless steel with copper-enriched stainless steel shelves, brackets and plenum components. A directional airflow and containment plenum surrounds the UV exposed humidity reservoir in a removable, stainless steel pan. The multi-faceted approach to contamination control is designed to destroy airborne particulates introduced during door openings, as well as contaminants that grow in the water reservoir. With active and passive systems working together in the SANYO performance model, contaminants that inevitably enter the chamber through routine door openings or other means are intercepted and destroyed while cell culture continues uninterrupted.

SafeCell™ UV tests on humidity pan water demonstrate how periodic exposure to narrow bandwidth ultraviolet light destroys bacterial and fungal contaminants, including thermophilic organisms, which migrate to the humidity pan water during routine door openings.

Organisms were suspended into humidity pan water at cabinet base, then exposed to SafeCell™ UV emission for determined period. Sample water solutions of 0.2ml were plated on nutrient agar plates and cultured prior to observation of colonies.

Together with the passive resis-

tance of copper-enriched stainless steel, the active effort to destroy airborne contaminants in-vitro forms an effective Active Background Contamination Control™ unique to the SANYO incubator with UV sterilization function. As the cell culture process proceeds in the incubator chamber, the work of germicidal protection from airborne organisms continues unabated without costly downtime. This protection extends to thermophilic organisms as well.

InCuSaFe™ construction for germicidal protection The exclusive use of InCu SaFe™ copper-enriched stainless steel alloy interior surfaces within a technical design created to eliminate contamination sources and to mitigate the effect of airborne contaminates introduced through normal use.

• Selected to provide natural germicidal protection without rust or corrosion, InCu SaFe™ expresses a natural germicidal attribute to inhibit the growth of molds, fungi, mycoplasma and bacteria when exposed to humidity and CO2.

• All interior components, including the air management plenum, shelf supports, humidity pan and blower wheel assembly are easily removable without tools if required.

• During the H2O2 sterilization cycle interior components can be repositioned within the chamber for in situ sterilization.

• All interior surfaces are exposed for conventional wipe down.

• Large curve corners and electropolished surfaces are easy to clean.

• Pass-thru ports accommodate probes or instrumentation leads as required for specialized cell culture protocols. Each chamber includes a port positioned in the rear wall, upper left, with dual silicone stoppers inside and outside the cabinet for added protection.

The Sterisonic™ GxP Model MCO-19AIC(UVH) incorporates a series of internal systems, processes and design factors that work together to maintain a multi-layered defense against contamination in the in vitro environment. Integration of a safe and effective two-hour sterilization process, the fastest in the industry, using an H2O2 vapour atomizer offers total sterilization of all interior surfaces and return to service more quickly than conventional incubators that use high heat sterilization. As a result, the SANYO incubator can be used for a broader range of cell culture applications, including the industry’s most highly regulated protocols.

References 1. Deepak Mistry is Strategic Development and Marketing Manager, Environmental Division Leader, SANYO North America Corporation, Biomedical, Environmental, HVAC and Food Divisions, 1300 Michael Drive, Suite A, Wood Dale, IL 60191. Hiroki Busujima is Chief Researcher for SANYO Electric Company, Ltd., 1-1-1 Sakata Oizumi-Machi, Ora-Gun, Gunma 370-0596, Japan. Matt Sibert is Sterisonic™ GxP Product Manager. Correspondence should be directed to Mr. Mistry.

2. DeSorbo, Mark A.; March 3, 2009, Contamination Control for the Life Sciences; Vaporized Hydrogen Peroxide, “… a neverending quest for sterility, safety and quality assurance.”

3. Caputo, Ph.D.,Ross A.; Robert Reich, Jim Fisher, Robert E. Byrnes, Ph.D.; March 3, 2009; Contamination Control for the Life Sciences; VHP: The Sterilant of Choice, Characterization, Properties and Biological Effects of Vapor Phase Hydrogen Peroxide.

4. Agalloco, James, 2008; Member, USP Microbiology and Sterility Assurance Expert Committee: Quality of Manufactured Medicines, General Session II, Wednesday, September 24, 2008; Performance Testing, Microbiology Topics - A Look to the Future: USP Activities Impacting Sterilization & Sterility Assurance [71, Sterility Testing; 1211, Sterilization/Sterility Assurance; 1229 Sterilization Methods].

5. Aldridge, Ph.D., Susan; February 15, 2007; Genetic Engineering News; Techniques for Cell Culture Improvement.

6. Typical applications such as in

vitro fertilization, stem cell culture, regenerative tissue culture, autologous cell culture or proprietary pharmaceutical processes require the CO2 incubator to be vacated, completely sterilized and validated at the conclusion of one process or batch and preceding the next. The speed and efficacy of the SANYO H2O2 system permits frequent sterilization with validation under these mandates with the benefit of short lead time, minimal preparation, quick cycle and resolve and fast return to service, usually within three hours.

7. Validating Report of Decontamination Effect on Incubator by Hydrogen Peroxide Gas (Abstract) Tested Product SANYO CO2 incubator, MCO-19AICUVH with H2O2 decontamination kit, MCO-HL and H2O2 generator, MCO-HP Test Result: With no BI (Biomedical Indicator) growing was observed in every BI collected from all setting locations inside chamber, the decontamination of the inner chamber of the incubator by hydrogen peroxide gas was verified. Residual H2O2 gas level in the inner chamber after the decontamination process / UV decomposition process was below 0.1ppm which is the lower detection limit. Abstract of Test Report : No. 20-0289 issued on 5th November 2008 KITASATO Research Center of Environmental Sciences 1-15-1 Kitasato Sagamihara city Kanagawa, Japan.

8. Marketed as SafeCell UV, US Patent 6,255,103.

9. Where indicated, independent testing funded by SANYO Commercial Solutions and performed

by Celsis Analytical Services, 6200 S. Lindbergh Blvd., St. Louis, MO, 63123 USA, Celsis is an FDA registered cGMP analytical services laboratory and functions under current Good Manufacturing Practices (cGMP) and applicable Good Laboratory Practices (GLP). Celsis has been successfully audited by regulatory agencies (FDA, EPA, DEA). www.celsis. com/lab. Detailed test results are available from SANYO, toll-free (800) 858-8442.

10. Association for the Advancement of Medical Instrumentation, Working Group, ISO/DIS 14161, Sterilization of Healthcare Products, Biological Indicators, Guidance for the Selection, Use and Interpretation of Results; December 3, 2007.

Resolution to develop a new

Learn more about Cell Culture on our Lab Products Web Portal at www. bioscienceworld.ca

)T ALL ADDS UP IN THE END Call Wyvern and save 30% or more on cartridges for your lab water system. % Proven, quality replacement cartridges for most makes of lab water systems % Free technical support and seminars % 20 Years Water Purification Experience % Guaranteed quality and satisfaction For more information about Wyvern’s water purification products, or to place an order, call or fax ---, visit .. or email sales@wyvernsci.com

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January 2010 Laboratory Focus www.bioscienceworld.ca

Feature

By J oel P el , S w eta R ajan , A u stin S o and A ndre Mar z iali

Efficient Genomic

DNA Extraction from Low Target Concentration E. coli Cultures using SCODA DNA Extraction Technology

Introduction Extraction of nucleic acids is straightforward using common kits in instances where there is ample nucleic acid mass in the sample, and the starting concentration of molecules is sufficient. Increasingly, methods in life science research, clinical research, and forensics are being driven toward smaller amounts of starting materials, or more dilute samples, requiring sample preparation methods to be more efficient at extracting nucleic acids that are dilute or in low abundance. SCODA technology has been tested with highly contaminated and dilute samples1, and is a promising candidate for new sample preparation challenges. In this brief, we present a comparison of SCODA versus common extraction methods in purification of small volumes of E. coli cultures, as an example of SCODA’s performance with limited sample material.

Materials and Methods

Bacterial lysate preparation E. coli cultures were prepared by growing the cultures in Luria-Bertani (LB) broth for 16 hours at 37 °C with a constant agitation of 225 rpm. Typical OD600 values after growth were between 2.5 and 3. Aliquots of 0.4mL of the growth were diluted 1000-fold (to generate the equivalent of 0.4 μL of culture) and transferred to 1.5 mL microcentrifuge tubes and pelleted for 5 minutes at 5,000 x g, after which the supernatant was carefully removed. The pellet was then resuspended in 0.1 mL of 1x BLB buffer (50 mM Tris•HCl, 50 mM Na2EDTA, 0.5% SDS, pH = 7.5). 1 μL each of RNase A (4 mg/ml in dH2O), lysozyme (50 mg/ ml in dH2O) and Proteinase K (20 mg/ml in dH2O) was also added to each tube, and the whole solution was incubated in a dry bath for 20 minutes at 37 °C. After incubation, the DNA was solubilized and sheared by passing the sample through a 21 gauge syringe ten times. The needle was then rinsed with 0.05x TBE (4.5mM Tris-Borate, 0.1mM EDTA), with the rinsate being added to the lysate sample to a volume of 1 mL.

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Laboratory Focus January 2010

fEATuRE DNA Purification and Extraction After lysis, DNA purification and extraction was performed using the SCODA 1.4 Development System (Boreal Genomics). A standard 4 mm thick, 1 per cent agarose gel with central extraction well was cast in the system, with 0.25x TBE buffer in the gel, extraction well, and buffer reservoirs. The system was set for 1 mL input volume, and the lysate was loaded into the sample chamber. DNA was injected from the sample into the system at 90 V for 30 minutes, after which the sample chamber was cleared and replaced with running buffer. A simultaneous concentration and contaminant wash step was then applied for 1 hour, with 50 V/cm nominal SCODA fields, and a rotational period of 4 seconds. A 5 V washing bias was applied towards the sample chamber to remove contaminants.

After the wash step, a final concentration step was applied for 2 hours, with 50 V/cm nominal SCODA fields, and a rotational period of 4 seconds.

Purified DNA was then removed in 50 μL of buffer from the central extraction well.

As a benchmark, equal volumes of lysate were also purified using a solid phase extraction method, the QIAGEN Genomic-tip 20/G Kit (Part No. 10223) as per manufacturers instructions, as well as a standard Phenol/Chloroform extraction (Sambrook and Russell, Molecular Cloning, 3rd Ed. CSHL Press).

48.5 kb range (Figure 1).

DNA Yield and Contaminant Rejection DNA yield for each method is summarized in Figure 2. In these experiments, performed in duplicate, the SCODA method recovered 50-fold more DNA than the next best method, Phenol/Chloroform extraction, and nearly 300-fold more DNA than the QIAGEN method. Dilutions of the recovered DNA samples in PCR indicate there was no inhibition in amplification for any of the three methods (data not shown), thus indicating high purity of the recovered DNA for all methods.

The higher recovery of the SCODA method may be attributed to the fact that SCODA extraction and purification relies on the physical properties of the DNA molecules, as opposed to binding interactions with a solid matrix, or precipitation. As a result, the low surface area-to-volume ratio of the SCODA system reduces loss of molecules to irreversible binding and dead volume. In addition, precipitation, which works poorly in low molecule concentrations, is not required for SCODA. These results highlight SCODA’s strengths in recovering small amounts of DNA from contaminated samples, also demonstrated in1.

figure 1

PfGE Analysis of Recovered DNA from Phenol/ Chloroform, QIAGEN and SCODA methods.

Conclusion

DNA Analysis The recovered DNA from each method was assayed for length, total DNA yield, and purity. Length was determined by loading a portion of an undiluted 0.4 mL culture aliquot processed with each method (so that DNA was in high enough concentration to visualize) with a standard marker on a pulsed field gel electrophoresis (PFGE) system, run with a 1per cent agarose gel in 0.5 x TBE, with 6 V/cm fields at a fixed temperature of 14 °C for 10 hours. Switch times were ramped between 1 and 12 seconds. After electrophoresis, the gel was stained with SYBR Green I. Total DNA yield was determined using quantitative real-time PCR analysis and a reference curve of E. coli genomic DNA standard (10 ng – 0.1 pg). Purity was assayed by comparing PCR amplification points and inhibition over a dilution series of the DNA samples.

A new method for the recovery of small amounts of genomic DNA has been developed, using SCODA DNA purification technology. From 0.4 μL equivalent of overnight E. coli culture, the SCODA method delivered over 50-fold more DNA than a manual Phenol/Chloroform extraction and nearly 300-fold more than the QIAGEN Genomic-tip 20/G Kit. In addition, the SCODA method extracted genomic fragments up to around 194 kb in length, which is comparable to the QIAGEN kit, but is over 100 kb greater in length than a Phenol/Chloroform extraction. All three methods produced DNA that was amplifiable in PCR. Overall, the SCODA method performed as well as or better than each of the comparative methods in length recovery, purity and total yield.

While these extractions are from an abundant source (culture media), the results are indicative of the strength of the SCODA technology in recovering DNA from dilute or low abundance samples.

Results and Discussion

References:

Fragment Length PFGE analysis of the purified DNA indicates that the SCODA and QIAGEN methods both produced DNA where the majority of fragments were between 23 kb and 194 kb in length, while the Phenol/Chloroform method produced fragments around the 23-

1. Pel J, Broemeling D, Mai L, Poon HL, Tropini G, Warren RL, Holt RA, and Marziali A “Non-linear Electrophoretic Response Yields a Unique Parameter for Separation of Biomolecules” PNAS, 2009 September 1; 106(35): 1479614801.

QIAgEN and SCoDA methods show recovery 194 kb down to below 23 kb, while Phenol/Chloroform ranges between 23 and 48.5 kb.

figure 2

DNA Yield from Phenol/Chloroform, QIAGEN and SCODA methods.

Qualitative Real-time PCR analysis of extracted DNA yields shows an average of 2.92 ng of DNA recovered using the SCoDA method, 0.06 ng using the Phenol/Chloroform method, and 0.01 ng using the QIAgEN method. Each experiment was performed in duplicate.

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New Products Pump Watson-Marlow Pumps Group launches its 520Di dispensing pump for accurate metering, dosing and transferring of sensitive fluids in sanitary environments. Ideal for filtration, fermentation and dispensing applications, the 520Di accepts eight different tubing materials and sizes up to 9.6mm for flow rates ranging from 4 microlitres/min up to 3.5 litres/ min and pressures up to 100 psi. The 520Di combines the rugged ability to perform in process applications with dispensing and dosing programming to handle the most delicate laboratory environments and the accuracy demanded in filling lines in Biotech and Pharmaceutical production. The 520Di is also suited for benchtop media or reagent preparation in laboratory suites; filling or inoculating bottles, vials, petri dishes and media bags. Up to 50 individual dispensing programs, including all dose parameters and calibration, can be stored in the memory with full, 8-character file names. Equipped with a brushless DC motor, it has a speed range of 3500:1 and over a million to 1 flow range, offering total flexibility of speed control combined with precision and repeatability for the most demanding dispensing applications. A number of different pump heads can be fitted to suit the user’s needs. Combining extraordinary levels of functionality with an on-screen menu, the 520Di features an easy-to-use tactile membrane keypad and an alphanumeric display in English, German, French, Spanish and Italian.

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Software Eppendorf announces the latest version of its PC software for controlling the epMotion automated pipetting system. EpBlue ID™ incorporates a new barcode management functionality to provide secure sample tracking. Operating and programming is easy and fast – even complex methods can be generated in minutes with intuitive menus and a tab-based structure that guides the user through the software functions. An unprecedented ease of use is capable through pipetting pattern recognition, a pre-defined labware database, and built-in and organized liquid classes.

This latest version of the epMotion operating system is specifically for users working in regulated areas where sample safety and the requirement to track and document each individual specimen are of paramount importance.

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Software The new Thermo Scientific BindIt 3.1 software has been developed for use with all Thermo Scientific KingFisher magnetic particle processor instruments. The software enables users to create new purification protocols or modify existing ones. Providing the highest possible throughput, the software also enables the KingFisher® Flex to interface with liquid handling and plate stacking instruments as well as robotics. With ready-made and validated purification protocols available, BindIt 3.1 software lets users choose the best method for a sample process. Once created, custom protocols can be stored in a PC database and transferred to the KingFisher instrument memory for stand-alone operation or run directly from the PC. All steps in the process have modifiable, defined parameters, and users can generate a status report to maintain quality control. This can include data on the run log, plate layout and step parameters.

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January 2010 Laboratory Focus www.bioscienceworld.ca

Power detector Gigahertz-Optik introduces the ISD-1.6-Si-1 and ISD-1.6-SiFC-1 radiant power detector featuring a compact 16mm diameter integrating sphere for beam emitter type light sources like laser diode dyes and optical fibers. The small footprint 43.5 x 25 x 17.5mm size detector primary function is to fit inside existing equipment and tight enclosed spaces to measure beam power through its 3mm measurement port. The silicon photodiode detector offers a wide spectral range from 400 to 1100nm and a typical absolute sensitivity of 200 µA/W at 630nm (500 mW max power). The detector head is traceably calibrated and certified to international standards. The ISD-1.6-Si-FC-1 model includes a FC connector to allow connection of a spectrometer in case spectral data is required. The FC connector is mounted opposite the measurement port to collect the maximum amount of light signal for high resolution spectrometers with limited sensitivity. A near-infrared version with an InGaAs photodiode to cover the 800nm to 1700nm spectral range is also available.

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Pipetting instrument The LCP technique for crystallizing membrane proteins can be difficult and time-consuming to set up by hand as it utilizes highly viscous lipid mesophases to reconstitute proteins. TTP LabTech has overcome these problems with mosquito LCP, a dedicated pipetting instrument for automated LCP screening set-up. This new product boasts the full functionality of the renowned mosquito product, whilst incorporating technical innovations specific for LCP techniques. Developed in collaboration with senior researchers from the MRC, UK; this instrument facilitates the automation and increased throughput of lipidic cubic phase (LCP) crystallization set-ups. Using a positive displacement syringe with automated tip positioning, mosquito LCP provides accurate and repeatable dispensing of the LCP drops. The precise positioning of the LCP material also facilitates automated imaging of membrane protein crystals in a range of high density plate types. For the precipitant additions step, this not only guarantees zero cross-contamination, but negates the need for time-consuming tip washing. Subsequently, high throughput rates of more than eight 96- well plates per hour are easily achieved and evaporation of the dispensed LCP is minimized.

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Turbopumps Featuring a rotor design, HiPace Turbopumps provide reduced run-up time, higher gas throughput and exceptional compression for light gases. The compact HiPace, is offered in a variety of drive versions, including Profibus and DeviceNet, has integrated drive electronics, which reduces bulky and costly cabling. Innovative materials have doubled drive service life, while a proven Pfeiffer Vacuum bearing design ensures reliability, even in harsh applications. Available in pumping speeds from 10 to 700 l/s, HiPace can be installed in any orientation.

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New Products

Spectrometer The i-LABR hand-held analyzing spectrometer from MicrOptix Technologies has broad applicability for field research, laboratory, and process applications. The i-LAB features software that allows users to create customized spectral measurements and analysis routines for use in the i-LAB.The current i-LAB model measures the Visible light range (400700 nm). Several measurement methods for Quality Assurance/Control are included with the i-LAB. The i-LAB features several sample adaptor options for use with a variety of liquids as well as a surface reader adaptor for conducting solid surface reflectance measurements.

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Insertion Probe variant Stratophase, a specialist in real-time chemical and biochemical measurement and detection, has collaborated with the Centre for Process Innovation (CPI) to develop an Insertion Probe variant of its unique SpectroSens system. Enabling real-time monitoring of the bioproduction fermentation process, the multi-output SpectroSens Insertion Probes track compositional changes and monitor temperature in the liquid. Multiple discrete readings can be taken simultaneously at numerous locations, providing more reliable measurements and a reduced chance of false positives. As a result, the entire fermentation process can be precisely monitored to ensure excellent reproducibility and clear determination of the desired end-point.

The SpectroSens system sensors can be placed throughout the production process and networked via the control and analysis unit. Using only light at the point of measurement, the sensors are intrinsically safe and spark-free, removing any chances of ignition. The new Insertion Probe fits standard ports for dissolved oxygen (DO) and pH probes, enabling ultra-high resolution, optical microchip technology to be applied to existing benchtop and large-scale bioreactor equipment. Other applications of the new SpectroSens Insertion Probe include biofuel production and sustainable polymer development.

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Cell culture bioreactor New Brunswick Scientifics’ new 5 and 14 litre CelliGen™ BLU benchtop cell culture bioreactor offers all the benefits of single-use technology with the trusted performance and true scalability of a stirred-tank design. A compact control station includes options for 4-gas mixing and multiple thermal mass flow controllers for producing high cell densities in research or GMP production. The singleuse vessel eliminates autoclaving and cleaning, provides rapid turnaround between runs and reduces risk of contamination.

Its integrated control station enables advanced gas management and process control while its unique pH and DO technology makes probe insertion totally noninvasive, eliminating contamination risk and making probe autoclaving unnecessary.

Reply Card #4309

Calcium Assay Kit Calcium flux assays are preferred methods in drug discovery for screening G protein coupled receptors (GPCR). The Screen Quest™ Calcium Assay Kit from amsbio provides a homogeneous fluorescence-based assay for detecting the intracellular calcium mobilization. Cells expressing a GPCR of interest that signals through calcium are pre-loaded with a fluorogenic cell-permeable calcium indicator which can cross cell membrane. Once inside the cell, the lipophilic blocking groups are cleaved by non-specific cell esterase, resulting in a negatively charged fluorescein dye that stays inside cells and its fluorescence is greatly enhanced upon binding to calcium. When cells stimulated with screening compounds, the receptor signals release of intracellular calcium, which greatly increase the fluorescence of the calcium indicator. The kit also provides an optimized assay method for monitoring G-protein-coupled receptors (GPCRs) and calcium channels. The assay can be performed in a convenient 96-well or 384-well microplate format and easily adapted to automation.

Reply Card #4310

Power Supply Extech Instruments, a supplier of handheld test and measurement equipment, announces the new 382275 600 Watt switching mode DC bench power supply (120V).

The new power supply is an easy-to-configure, highly stable, lab grade DC power supply with maximum output power of 600W. It offers two degrees of control over both current and voltage outputs; coarse and fine. Output is adjustable from 0 to 30V DC and 0 to 20A with (0.1V/A resolution). Dual green LED displays offer easy-to-read, high contrast readouts of voltage and current values. The Extech 382275 offers four operating modes: normal mode, with values controlled by front-panel knobs; preset mode, which offers three popular voltage presets at 20A: 5.0V, 13.8V, and 25V; set mode, with three user-customizable presets; and remote control mode, where the user can remotely adjust output power on/off, voltage and current. Other features include automatic constant current and voltage, high RFI immunity, excellent EMI, a thermostat-controlled variable speed fan, as well as over-voltage, over-temperature, and short circuit protection. The 382275 offers a compact, low profile design and small footprint (7.9 x 3.5 x 8.5 in., 200 x 90 x 215 mm; 5.7 lbs, 2.6 kg) without compromising output noise and transient response factors.

Reply Card #4311

Automated cell counter Millipore Corporation introduces its Scepter™ handheld, automated cell counter. Scepter miniaturizes coulter cell counting technology found in much larger instruments into a portable device the size of an automated pipette. The instrument contains sophisticated electronics for cell sensing, signal processing, and data storage. A graphical display reports the cell count and average cell volume within 20 seconds of inserting the tip into a cell culture sample. In addition to showing cell counts and average cell volume, the instrument also displays a histogram of cell distribution by volume or diameter. The histogram can be used to provide an instant snap shot of the health of the culture.

Results can be stored on the instrument or downloaded to a computer.

Reply Card #4312

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Janaury 2010 Laboratory Focus www.bioscienceworld.ca

New Products Vacuum gauge BrandTech Scientific introduces a new vacuum gauge from VACUUBRAND®. The DCP3000 + VSP3000 uses the Pirani principle of thermal conductivity to measure in the fine vacuum range. It incorporates a new patent-pending VSP3000 transducer that is substantially more chemically resistant and mechanically robust than earlier designs, making it an excellent choice for both chemistry labs and process applications. The dis-

play module DCP3000 has the ability to connect up to three additional VSP3000 transducers. Automatic configuration of the display unit to gauge heads and solenoid valves is via VACUUBRAND’s VACUU•BUS plug-and-play system. Up to four additional VSK3000 capacitive gauge heads for the rough vacuum range can also be connected, for a total of up to eight transducers. A solenoid vent valve can be added to vent the application. The displayed pressure

can be measured in your choice of units—Torr, millibar or hectoPascal.

Digital and analog displays provide both precise readings and trend indication. A “turn-and-push” jogwheel interface allows for easy navigation of menus. The set includes 100-230VAC / 50-60Hz universal power supply with US, CEE, UK, CH and AUS plugs.

Purchase through preferred laboratory supply dealers.

Reply Card #4313

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AEterna Zentaris...............................4.........................

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BrandTech Scientific..........................16................4313 Caledon Laboratory Chemicals.........5.................4296 Cedarlane........................................4.................4295 Chemical Institute of Canada....................................... and the Canadian Society ........................................... for Chemical Technology..................9.................4299 Centre for Drug Research............................................. and Development...............................1.........................

Elan Corporation................................1.........................

Eppendorf........................................14................4302 Extech Instruments..........................15................4311 Fisher Scientific...............................2.................4294 Genome BC.......................................4.........................

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MicrOptix Technologies.....................15................4307 Millipore Corporation..................15, 20...4312, 4315 National Research Council.............................................

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Thermo Fisher Scientific....................14................4303 Transition Therapeutics Inc.................1.........................

TTP LabTech.....................................14................4305 Warnex Pharmaceuticals....................6.........................

Watson-Marlow...............................14................4301 Wyvern Scientific Inc......................11................4300 YM BioSciences Inc............................5.........................

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January 2010 Laboratory Focus

One small step, one giant leap for better

science policy in Canada

B

orn out of a growing perception that Canadian science policy needs to be shaped by an ongoing critical discussion, the first National Canadian Science Policy Conference held in Toronto, October 28-30, brought together notable names in industry, government and academia to discuss Canada’s science policy shortcomings.

Approximately 60 speakers addressed more than 400 delegates on a variety of topics related to science policy. Conference chair, Dr. Mehrdad Hariri, was overwhelmed by the higher than expected turnout.

“We had great feedback on the number and quality of the speakers and that the content was well timed. There was lots of networking going on, with all sides getting to hear from one another,” said Hariri.

Of note was Preston Manning’s keynote address on the second day of the three-day event. His presentation titled: Overcoming the challenges to better science policy in Canada, brought up many key points as to why science in Canada is lagging, including why it has so little influence in Ottawa. One key fact Manning offered up was that of the some 400 MPs and senators in Canada, he could count at most eight who had a solid science background of any kind. For this reason the two sides (government and academia) don’t see eye to eye.

“There is disconnect between actual scientists and the people who control and distribute the funding,” he explained. As such he felt that more effort was needed to bridge this communication gap between scientists and politicians.

While much of Manning’s presentation was served to champion the scientific community, Manning did not deny that a more conscious commitment was needed to support R&D in the private sector also.

Other notable speakers included Ontario Minister of Research and Innovation John Milloy and Junior Minister for Science Gary Goodyear.

Attendees were also given the chance to convey their thoughts through conference evaluation forms. Already, more than 60 evaluation forms have been filled out and analyzed. Dr Hariri expects this number will continue to grow.

Conference-goers also made extensive use of the interactive message board found on the event’s website. The interactive tool was used to analyze the presentations, as well as generate debate on a diverse range of topics.

Overall, it seemed that conference organizers did their homework by putting together a stellar program. There was also a sense of real promise and that progress was being made.

One of the other aims of the conference was the creation of a “science policy network.”

The consensus opinion was that this effort was a good start. In fact, there is hope that the discussion about science policy started in Toronto will progress, to lay a foundation for such a network, and as a very real possibility that the first steps have been taken to establish a Canadian “Virtual Institute” for science policy research. Both developments would go a long way to alleviating the frustration of the research community in getting their voices heard. Canada has much to gain if such an idea is realized.

OLD

CAREER SPOTLIGhT Compiled by BioTalent Canada Position: Chief Scientific Officer Name: Denis Kay Company: Neurodyn Inc. Salary Range: $80,000 to $100,000 per year

What I do:

I’m the coordinating point for research & development and communication with our partners. I’m a jack-of-all-trades: I’m trained as a research scientist, but I’m also doing some business development.

A fair bit of my time is spent in administration, and the day-to-day running of the business. Most of my time is spent in data analysis, which is the main focus of the company at this point: to make sure our intellectual-property portfolio is strengthened through research and development. Travel is part of my job to a limited extent; it’s typically to go to trade shows and company meetings. The vast majority of my time is spent in the lab. I work in a new research institute. It’s one of five life science institutes across Canada that the National Research Council of Canada operates, and it is a partnership facility housing six company incubator facilities for biotechnology companies. It’s a dynamic mix of corporate, academic, and government-research types – a very fertile environment.

What education and skills do candidates need for this position?

There are a number of paths to working in this position. Lack of career experience is not a barrier to enter into the biotechnology field. For more senior positions, however, experience is obviously an asset. My experience probably made it easier to jump in with some momentum behind me. I spent 20 years working in academic science after my Ph.D., and the type of science in which I was engaged prepared me very well to move into the position I’m in now – a confluence of career timing and the type of science I’d done in the 20 years preceding. In terms of skills, you have to have an absolute passion and zeal for discovering new things. You have to have a real sense of optimism despite things that go awry – they certainly will. That persistent effort will eventually pay off.

What are the best parts of your job?

The best thing about the job is that it’s science. Even though the finances of an emerging biotechnology company are not unlimited, it’s a far richer environment in which to do the science than a pure academic environment. The ability to move more quickly toward an end point is probably the most exciting part of what I’m doing.

The work we do at Neurodyn is of potentially great benefit. We are trying to find some early markers for the neurodegenerative disease process. If we’re successful, then there will be real benefits in terms of improved diagnosis and treatment of neurodegenerative disease derived from the work.

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Reply card #4315

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