Laboratory Focus November/December 2018

Pharmaceutical

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Clinical

Chemical

w w w. l a b o r a t o r y f o c u s . c a

Five data management challenges in genomics research labs Page 8

food

environment

November/December 2018 Volume 22, Number 4

Electrostatic Powder Coating for Pharmaceutical Applications Page 12

R&D News.................. 1 Appointments............. 6 New Products........... 16 App Reviews.............. 19

IMV triples its space to expand business and operations

Councillor Sam Austin, Minister Randy Delorey, MP Darren Fisher, IMV Chairman Andrew Sheldon, IMV CEO Frederic Ors, IMV CMO Gabriela Rosu, and IMV CFO Pierre Labbé participated in today’s grand opening event for IMV’s new facilities in Dartmouth. (Photo Credit: IMV) IMV Inc., a clinical stage immunooncology corporation, celebrates the grand opening of its new facilities in Dartmouth, Nova Scotia.

Frederic Ors, IMV’s Chief Executive Officer, and Andrew Sheldon, IMV’s Chairman of the Board, opened the event with remarks about the company’s milestones and successes. Other speakers included federal MP Darren Fisher, the Honourable Randy Delorey, Minister of Health and Wellness, and Dartmouth Centre Councillor Sam Austin. Emilie Chiasson, the Atlantic Regional Director of Ovar-

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ian Cancer Canada, served as the event’s Master of Ceremonies.

“The opening of our new facility marks another successful stage of growth for IMV, which will enable us to accelerate and expand on our ambitious research and clinical development programs,” says Frederic Ors. “We are focused on attracting and retaining the best employees for a clear purpose: to develop breakthrough immunotherapies for individuals living with serious medical conditions such as ovarian and lymphoma cancers. We look forward to continuing our growth

with the strong support of the local community in Nova Scotia.”

The company moved from its offices and laboratories located in the Innovacorp Enterprise Centre on Summer Street, Halifax, to the Bluefrog Business Campus in Dartmouth to accommodate the growing business. The new space features upgraded facilities and equipment as well as increased laboratory size and capacity. IMV

has now nearly tripled its space to allow for expanding business and operations in the coming years.

“IMV is providing high-quality jobs for our region’s educated workforce, helping to attract and retain talent. It is also drawing international attention to the work that is being done within the life sciences community in Nova Scotia,” says Darren Fisher, Member of Parliament for Dartmouth-Cole Harbour, on behalf of the Honourable Navdeep Bains, Minister of Innovation, Science and Economic Development and Minister responsible for Atlantic Canada Opportunities Agency (ACOA).

“This kind of recognition, combined with business successes such as becoming a publicly traded company on the TSX and Nasdaq, has helped to bring significant investment to the area. This is why the Government of Canada, through the ACOA, has been a proud supporter since the get-go, assisting with funding for research and development, patent protection, and bringing the company’s product candidates to market.”

To see this story online visit https://laboratoryfocus.ca/ imv-triples-its-space-to-expandbusiness-and-operations/

WCHRI receives $5-M to further children’s health program Thanks to a $5-million investment, the Distinguished Researchers child health research program will run at the Women and Children’s Health Research Institute (WCHRI) in Edmonton, Alberta.

The principle of the program will be that through research, the funding will address difficulties facing

children and youth as they work through health challenges.

The primary funder was the Stollery Children’s Hospital Foundation, with support from the University of Alberta and Alberta Health Services’ Stollery Children’s Hospital.

“The Distinguished Researchers Continued on page 3

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November/December 2018

news PUBLISHER/EDITOR-IN-CHIEF Terri Pavelic Writer Michelle Currie CONTRIBUTING WRITERS Nidia Lauzon Pierre Chaurand Derek Wilson Cristina Lento Jerry Fireman GRAPHIC DESIGNER Elena Pankova CONTROLLER John R. Jones MARKETING MANAGER Melisa Sukhdeo CIRCULATION DIRECTOR David Blondeau circulation@promotivemedia.ca Tel: 905-841-7389 OFFICE: 226 Edward St. Unit 1 Aurora, ON L4G 3S8 Phone: 905-727-3875 Fax: 905-727-4428 E-mail: laboratory_focus@ promotivemedia.ca SUBSCRIPTION INQUIRIES mary@promotivemedia.ca Fax: 905-727-4428 Laboratory Focus is published 4 times per year by Promotive Communications Inc. Legal Depository: National Library of Canada ISSN 40052410 Subscription rate in Canada $35/year; USA $60/year; other countries $100/year.

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WCHRI receives $5-M Continued from page 1 program is about inspiring people to see what’s possible,” says Mike House, president and CEO of the Stollery Children’s Hospital Foundation. “We’re really lucky to have in Edmonton some of the best researchers for pediatric care anywhere, and this team is elevating that care right in our own backyard and across the globe.

What excites us is the knowledge that we can transform children’s health together.”

Andrew Mackie, an associate professor of pediatric cardiology at the University of Alberta, a cardiologist at the Stollery Children’s Hospital and a member of the Women and Children’s Health Research Institute (WCHRI) was named as one of the seven distinguished researchers to pursue initiatives and improve pediatric health in Alberta and around the world.

With the new funding, he aims to find solutions that help more young people and to expand the reach of his work to include children with developmental delays, Indigenous and immigrant youth, and adolescents with multiple chronic conditions.

The seven scientists, who have been named distinguished researchers within the Stollery Science Lab, will also act as ambassadors of children’s health

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The 2018 Stollery Science Lab Distinguished Researchers are:

• Todd Alexanderis working to better understand and develop personalized drug therapies for children with rare kidney diseases.

• Lisa Hartling and Shannon Scott are building decision-making tools that equip families with enough infor-

mation to make the best decisions possible for their children and their families.

• Michael Hawkesis developing solar-powered oxygen delivery systems to improve outcomes for childhood infections around the world — especially in high-burden, low-income settings like Africa.

• Andrew Mackieis helping kids with complex needs transition to adult care — improving patient safety, survival and outcomes.

• Kate Storeyis leading a peer-led mentorship program that will empower Indigenous teens and improve their health and wellness.

• Lonnie Zwaigenbaumis developing early intervention strategies to screen infants for autism. This will lead to targeted therapies for children who have autism.

To see this story online visit https://laboratoryfocus.ca/wchrireceives-5-m-to-further-a-childrens-health-program/

The NRC donates over $190,000 to Microbiome Insights for development of a new platform

All opinions expressed herein are those of the contributors and do not necessarily reflect the views of the publisher or any person or organization associated with the magazine.

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research in the community.

“It’s an exciting day when you get to launch a new program that supports researchers taking that next big step in children’s health research,” says Sandra Davidge, executive director of WCHRI. “This is all thanks to the generous donors to the Stollery Children’s Hospital Foundation, who understand the importance of research and its ongoing impact on children’s health in Alberta and across the globe.”

Through research, this funding will help address complications that face children and youth as they work through their health challenges in a unique environment.

The National Research Council of Canada donates $190,249 to Microbiome Insights from the Industrial Research Assistance Program (NRC IRAP) to help support the development of a new personal health platform for microbiome testing.

Co-founded by Drs. Brett Finlay and Bill Mohn at the University of British Columbia in 2015, Microbiome Insights is a rapidly budding company and a global leader in microbiome testing and bioinformatic analysis.

The advisory services and financial

assistance from the Government of Canada, through the NRC IRAP, will help the company expand in a new direction—continuing to develop tools for use in clinical settings as new data emerge on the gut microbiome and health.

“We’re leveraging our expertise in microbiome testing to develop a suite of tools for monitoring chronic disease in clinical practice,” says Microbiome Insights CEO Malcolm Kendall. “From the practitioner interface to the educational components of the test, our team is taking a fresh approach that is going to change the game for microbiome testing.”

The company’s primary goal for their personal health platform is to help address the challenges both healthcare practitioners and individuals face in the management of chronic disease. Microbiome monitoring in those with chronic disease may provide a means for assessing response to therapies or to various lifestyle

changes¬—particularly when integrated with robust research findings and ongoing data collection.

The company’s new testing platform will be aimed at health practitioners helping individuals who live with inflammatory bowel disease. The efforts are led by Nataša Jovic, MBA, who brings to the company twenty years of experience in therapeutic and diagnostic commercialization and is one of the selected executives recently announced to be in the inaugural cohort of CDRD Academy’s Executive Institute. Microbiome Insights is currently exploring opportunities to commercialize its platform of microbiome tests for healthcare practitioners through research collaborations and distribution or joint commercialization efforts.

To see this story online visit https://laboratoryfocus.ca/the-nrcdonates-over-190000-to-microbiome-insights-for-development-of-anew-platform/

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November/December 2018 Laboratory Focus www.laboratoryfocus.ca

news

The Good Food Institute launches global $3-M competitive research grant program The Good Food Institute launches a $3-million competitive research grant program to encourage universities and others to pursue plant-based and clean meat research. This money will be awarded to projects led by scientists from around the world and from any sector to advance knowledge within the fields of plant-based and clean meat.

Plant-based and clean meat has become quite the attraction in Silicon Valley, enticing investments from the biggest names in tech and venture capital, from Bill Gates and Sergey Brin to DFJ, Kleiner Perkins, and Google Ventures.

Even global meat giants Tyson, Cargill, and Maple Leaf have backed plantbased and clean meat startups.

Despite its potential to revolutionize

the food system and allow researchers to solve some of the world’s biggest problems – from climate change to antibiotic resistance – the Good Food Institute (GFI) estimates that less than 0.3 percent of the world’s universities are currently engaged in plant-based meat (PBM) or clean meat (CM) research.

To jump-start this research, the Good Food Institute (GFI) has identified the universities with the greatest potential to advance the important fields of plant-based and clean meat.

These 24 global universities have been identified for their relevant technical expertise, research capabilities, and private-sector partnerships. They are (in alphabetical order):

“While most of these schools are not yet working in these fields, their potential to become leaders in plant-based and clean meat research is impressive,” notes GFI Scientific Foundations liaison Dr. Erin Rees Clayton. “We would be thrilled to work with them to realize their potential to do cutting-edge science that will ultimately improve global health, food security, and environmental stewardship.”

There have already been examples of universities having a major impact in the space. USDA-funded research at the University of Missouri was key for the plant-based meat company Beyond Meat. Dr. Mark Post’s research at Maastricht University led to the first

Top 12 Global Universities for PBM

Top 12 Global Universities for CM

Cornell University (US)

Harvard University (US)

McGill University (Canada)

KU Leuven (Belgium)

Peking University (China)

Kyoto University (Japan)

Pennsylvania State University (US)

Lund University (Sweden)

Technical University of Munich (Germany)

National University of Singapore (Singapore)

Texas A&M (US)

Purdue University (US)

University of California, Davis (US)

Seoul National University (South Korea)

University of Minnesota (US)

Technion Israel Institute of Technology (Israel)

University of Nebraska-Lincoln (US)

University of Illinois at Urbana-Champaign (US)

University of Queensland (Australia)

University of Leeds (UK)

University of Tokyo (Japan)

University of Melbourne (Australia)

Wageningen University & Research (Netherlands)

University of Wisconsin-Madison (US)

NSERC awards Plantform and Guelph scientist with Engage Grant

The Natural Sciences and Engineering Research Council of Canada (NSERC) grants PlantForm Corporation and a University of Guelph scientist a $25,000 Engage Grant.

The funding will advance research

by Dr. Lewis Lukens who is focused

on understanding and limiting defense mechanisms in host plants with the goal of increasing the yield of target proteins produced in PlantForm’s vivoXPRESS manufacturing process.

The high-yield, low-cost vivoXPRESS system uses tobacco plants infiltrated

with Agrobacterium to express target proteins for development of biologic medicines and vaccines to treat cancer, inflammatory diseases and other life-threatening or debilitating conditions. Although the process uses nonvirulent strains, infiltration with Agrobacterium triggers defense responses in the plants that can limit the yield of the desired proteins.

The $25,000 Engage Grant will support research aimed at providing a comprehensive analysis of small RNA molecules (sRNA) generated in response to Agrobacterium infiltration and how they impact protein expression.

“Small RNAs (sRNAs) are known to play a role in plant defense and gene silencing,” says Lukens, an associate professor in Guelph’s Department of Plant Agriculture and a leading expert in bioinformatics and quantitative genetics. “The goal of this research is to identify and quantify sRNAs generated in response to Agrobacterium infiltration and transient transgene expres-

clean meat burger in 2013, followed by the formation of the clean meat company Mosa Meats.

“There are so many interesting scientific questions to answer,” says Dr. David Welch, GFI’s director of Science and Technology. “What are the best cell types and cell culture methods for clean meat production? Which crops produce the best plant-based meats and are best suited for growth in each region of the world? It’s a curious mind’s dream.”

Uma Valeti, MD, co-founder of clean meat company Memphis Meats, made the move from medicine to meat to maximize his impact. “If I continued as a cardiologist, I might save maybe a few thousand lives over the next thirty years. But if I am successful in helping to change the way meat is made, I could positively impact billions of human lives and trillions of animal lives.”

To see this story online visit https://laboratoryfocus.ca/the-goodfood-institute-launches-global-3-mcompetitive-research-grant-program/

sion, and to investigate if production of specific sRNA correlate with transgene expression and protein production.”

The project will help PlantForm continue to advance and improve the vivoXPRESS platform. On a commercial scale, a 10 per cent increase in the production of therapeutic proteins can result in millions of dollars in additional cost savings or revenue for the company.

“We’re very pleased to be working with Dr. Lukens and his team to develop methods to suppress transgene silencing and increase yields of recombinant proteins,” says Dr. Don Stewart, PlantForm’s president and CEO. “This project will generate novel insights into the role of sRNA in protein expression and further advance PlantForm’s strategy to make life-saving medications available at much lower cost.”

To see this story online visit https://laboratoryfocus.ca/nsercawards-plantform-and-guelphscientist-with-engage-grant/

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November/December 2018

Beleave and Kannavis to open 10 growing facilities in British Columbia Beleave Inc. partners with Kannavis Biotech Corp. to invest, build and operate 867,000 square feet of indoor growing space in British Columbia in preparation for the anticipated demand for cannabis with legalization in Canada just around the corner.

The joint project will include a total of ten indoor growing facilities, approximately 87,000 square feet each, divided between two regions; one in Chilliwack, and nine in Abbotsford.

Once construction is complete, both companies will share the operational and day-to-day expenses, with Kan-

navis assuming sole responsibility for the initial capital expenditures required to build the facilities.

Phase one of the development will begin with the construction of two facilities, one in each city, and is already underway. Both facilities are expected to be completed in mid-2019, with an annual projected capacity of 13,500 kg of dry flower each. The remaining eight facilities, planned for phase two of the development, are expected to commence construction in late 2019 bringing the total annual capacity of the Abbotsford site to 121,500 kg.

Thermo Fisher Scientific intends to open multiple Global Customer Solution Centers Thermo Fisher Scientific Inc., announces its intent to open multiple Global Customer Solution Centers.

The new Global Customer Solution Centers will focus on meeting and exceeding the demands of scientists in food, beverage, pharmaceutical and biotech laboratories by developing critical workflows and integrated solutions that help advance chromatography and mass spectrometry worldwide.

With the scientific community determined to overcome key hurdles such as global food security and the need to develop novel therapeutics faster, each Customer Solution Center will serve as an exclusive hub for scientists, customers and regulatory bodies to collaborate with Thermo Fisher subject matter experts. By bringing together leading minds and instrumentation, the network of sites will focus on training, support and the development of next-generation workflows and integrated solutions designed to increase productivity, ease-of-use and return on investment for customers.

“The announcement of the Global Customer Solution Centers demonstrates our commitment to helping scientists push research and technology to the next level,” says Jakob Gudbrand, president, chromatography and mass spectrometry, Thermo Fisher Scientific. “Our network of sites will create hubs around the globe for scientists, collaborating organizations and regulatory bodies to work together and develop workflows that will make the world healthier, cleaner and safer.”

“Our research team is confronted with real-life problems within the

biopharmaceutical industry every day,” says Christian Huber, professor and head of the Christian Doppler Laboratory for Innovative Tools for Biosimilar Characterization at the University of Salzburg, Austria. “The analytical tools we develop have significant potential of eventually being implemented in routine analytical workflows for quality control.

Our cooperation with the new Thermo Fisher Bio/Pharma Customer Solution Centers offers the possibility of employing the latest workflows for molecular characterization based on cutting-edge high-performance liquid chromatography and mass spectrometry.”

The inaugural phase of this new global strategic initiative will be marked by multiple Customer Solution Center openings in locations across the world. Each site will: • Drive toward quality by design (QbD) across the pharmaceutical markets to help increase product quality and yield, to develop more efficient and lean manufacturing processes which is anticipated

to ultimately preserve patient/ consumer safety so customers will have access to solutions to overcome unique and emerging analytical challenges.

• Collaborate with food regulators and standards agencies, utilizing the latest technology to develop methods to help ensure the global food supply is safer and healthier for human consumption.

• Embrace the opportunity to collaborate with customers and organizations in the development of next-generation workflow solutions in chromatography and mass spectrometry.

• Provide complete workflows to enable scientists to reach new levels of productivity.

To see this story online visit https://laboratoryfocus.ca/thermo-fisher-scientific-intends-toopen-multiple-global-customersolution-centers/

news

The new facilities feature an indoor system capable of precisely controlling the internal environment and growing conditions. This allows Beleave to maintain its industry-leading high-yields of 475 grams per square foot annually while keeping overhead costs low.

“Our British Columbia project will give Beleave the indoor capacity in the province to supply our established distribution channels, and enhance our ability to meet the need for high quality and diverse strains across Canada and international markets,” says Andrew Wnek, Beleave CEO. “B.C. has a rich reputation with respect to cannabis agriculture, and we’re excited to be growing in a province with such a strong tradition.

I want to thank our hard-working staff and partners for all their efforts to make this project a success.”

Beleave continues to operate its facility in Hamilton that houses highefficiency extraction, R&D, product development and cultivation of cannabis and cannabis derived products. The facility’s 80,000 square foot expansion will proceed as planned once final permits are granted. In the meantime, the site continues to be the hub of operations for extraction, packaging, and distribution.

“We have taken strategic steps to ensure that reliable, high-quality product is readily available for sale this October across all of our growing distribution channels,” says Bojan Krasic, Beleave CFO. “As we await permitting to finalize the expansion of the Hamilton facility, we will continue to produce product out of that property to support early sales efforts. Earlier this month we announced the acquisition of additional land and greenhouse space in London, Ontario which will bring yields in early 2019. With today’s announcement, we are adding hundreds of thousands of square feet of superior indoor grow space to our portfolio of properties. This strengthens our overall stance when measured against our larger peers.”

To see this story online visit https://laboratoryfocus.ca/beleaveand-kannavis-to-open-10-growingfacilities-in-british-columbia/

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November/December 2018 Laboratory Focus www.laboratoryfocus.ca

Appointments

The Alberta Medical Association (AMA) installs its new president for 2018-19 during its Annual General Meeting and Representa-

Dr. Alison M. Clarke tive Forum at the Hyatt Regency in Calgary. The AMA president serves a one-year term, in addition to one year each as president-elect and immediate past president. Dr. Alison M. Clarke will officially assume the role of AMA president at the end of the Representative Forum meeting. Dr. Clarke is a family physician with over 20 years of practice providing care to patients and their families in the rural community of Strathmore, Alberta. She is an admitting physician for acute and long-term care for Strathmore District Health Services and has been involved with primary care networks since the PCN concept was first established and participated in the original planning and implementation in the Strathmore medical community. She has been the medical director of the Calgary Rural PCN since 2014.

During the Annual General Meeting, current AMA President Dr. Neil Cooper will reflect on some of the highlights of his year as president and comment on the events and issues that have defined his term. Dr. Cooper will also officially welcome to Alberta the Canadian Medical Association’s 151st president, Dr. Gigi Osler. Dr. Osler became CMA president in August at the CMA’s

Dr. Gigi Osler

Annual General Meeting, held this year in Winnipeg. Dr. Osler is head of the Section of OtolaryngologyHead and Neck Surgery at St. Boniface Hospital and is an assistant professor with the Department of Otolaryngology-Head and Neck Surgery at the University of Manitoba. When working at St. Boniface Hospital, she is actively involved in the teaching of medical students and residents. As a dedicated advocate for global surgery and the promotion of safe, accessible surgical care, she volunteers annually on surgical missions to low and lower-middle income countries.

She was a member of Canadian Helping Kids in Vietnam’s medical mission to Long Xuyen, Vietnam, in 2011. For the last several years Dr. Osler has been volunteering in Mbarara, Uganda. Working with members of the Canadian Society of Otolaryngology-Head and Neck Surgery, the group collaborates with Mbarara University of Science and Technology to improve the quality of local health care through education, training and mentorship to surgeons, residents and medical students. A passionate advocate for physician health, Dr. Osler serves as chair of the Physician Health and Wellness Committee for Doctors Manitoba. The committee oversees the Physician and Family Support Program and creates events to promote physician wellness. In 2017, she received their Health or Safety Promotion Award in recognition of her efforts to develop and implement programs to support the health and well-being of doctors.

North York General Hospital (NYGH) appoints Dr. Joshua Tepper to the position of president and CEO. There was an extensive national search process that led to the appointment of Dr. Tepper. The NYGH sought an accomplished leader who is passionate about building on NYGH’s record of success as a high performance organization, and who will nurture their vibrant and distinctive culture.

Dr. Tepper is a family physician and is currently the president and chief executive officer of Health Quality Ontario (HQO), which works in partnership with Ontario’s health care system to support a better experience of care, better outcomes for Ontarians and better value for money. Dr. Tepper will officially begin his new role at North York General on November 5th. Prior to

‘We have a tremendous culture and a commitment to our patients and our community, all of which I hold as deeply important. It is a tremendous privilege for me to join the leadership team.”

Dr. Joshua Tepper

HQO, Dr. Tepper was the inaugural vice president of education at Sunnybrook Health Sciences Centre. As vice president, he was responsible for Sunnybrook’s educational strategy and programming for learners, physicians and staff, patients and their families and the community.

Before Sunnybrook, Dr. Tepper was Assistant Deputy Minister (ADM) in the Health Human Resources Strategy Division of the Ministry of Health and Long-Term Care. As the ADM, he led the Health Force Ontario health human resources strategy to ensure that Ontarians have access to the right number and mix of qualified health care providers.

Additionally, Dr. Tepper has been active on a national scale as the senior medical officer for Health Canada, an adjunct scientist at the Institute for Clinical Evaluative Sciences (ICES), and a research consultant for the Canadian Institute for Health Information (CIHI). He has received several provincial and national awards for his leadership in these positions. Dr. Tepper continually remains in active practice serving marginalized populations and taking on clinical leadership roles. He served as the medical director for the Inner City Health Associates and president of the Inner City Family Health Team. He completed Medical School at McMaster University and his residency in Family Medicine at the University of Toronto. Dr. Tepper holds a degree in Public Policy from Duke University, a Masters of Public Health from Harvard, and an executive Master’s of Business Administration from the Richard Ivey School of Business.

“North York General is a remarkable organization that I have been honoured to work with over many years in different roles, including as a physician,” says Dr. Tepper.

Vasomune Therapeutics, a leading biotechnology company developing therapeutics targeting vascular dysfunction and inflammation, announces that Douglas A. Hamilton has been appointed president and chief executive officer of the company. Mr. Hamilton will also be appointed to Vasomune’s Board of Directors. Most recently Mr. Hamilton served as president and CEO of MetaStat Inc., a precision medicine company discovering and developing novel anti-metastatic drugs for the treatment of patients with aggressive cancer. Prior to MetaStat, Mr. Hamilton served as partner at New Biology Ventures since 2007 and CFO of SEA Medical Systems from 2012 to 2014. Mr. Hamilton served as CFO and COO for Javelin Pharmaceuticals from 1999 to 2006 which was purchased by Hospira.

Douglas A. Hamilton He led the company through the development and commercialization of its first product and transition from a start-up to a publicly traded company. Prior to Javelin, Mr. Hamilton served as CFO and Director, Business Development at PolaRx Biopharmaceuticals. Mr. Hamilton has held various roles at Pfizer, Amgen, Pharmacia Biotech (now GE Healthcare Life Sciences) and Connaught Laboratories (now Sanofi-Pasteur). Mr. Hamilton earned his honors Bachelor of Science degree from Department of Medical Genetics at the University of Toronto and his MBA from Ivey Business School at Western University. Mr. Hamilton will succeed Parimal Nathwani, who will remain on the Board of Directors.

www.laboratoryfocus.ca

Laboratory Focus November/December 2018

Appointments

Ipsen Biopharmaceuticals Canada Inc., appoints Ed Dybka as general manager. Mr. Dybka will oversee Ipsen Biopharmaceuticals Canada’s operations across all therapeutic areas and report directly to Richard Paulson, CEO, Ipsen North America. Mr. Dybka will also be a member of the Ipsen North America Leadership Team. Mr. Dybka brings to Ipsen a wealth of experience and over 30 years in the pharmaceutical industry within the Canadian market.

Most recently, he led the development of an early stage biotech company as a joint venture between Mars Innovation and The Center for Drug Research and Development. “We are delighted to welcome Ed to Ipsen Canada as we establish new milestones on our path to maintaining strong growth and further expanding our relationships with researchers and organizations across the Canadian healthcare ecosystem,” notes Richard Paulson, CEO, Ipsen North America. “Ed brings a wealth of leadership expertise, a track record of fostering innovation, and an in-depth understanding of our industry garnered from his extensive work within the Canadian pharmaceutical market. He is a valuable addition to the Ipsen Canada team.” Prior to his work with Mars Innovation, Mr. Dybka was President and CEO of AstraZeneca Canada Inc., and formerly led the Canadian establishment of Almirall, a start-up biopharmaceutical company focused on the treatment of respiratory diseases. Mr. Dybka also held a number of executive roles at GlaxoSmithKline Canada including Vice President of Marketing, Sales and Public Affairs & Reimbursement. Earlier in his career at GlaxoSmithKline he held progressively more senior roles in sales and marketing. Mr. Dybka is currently vice-chair of the board of Life Sciences Ontario and a director on the board of Clinical Trials Ontario. He is vice-chair of

the Health & Biosciences Economic Strategy Table for the Federal Ministry of Health and Ministry of Innovation, Science and Eco-

nomic Development, which recently published a set of foundational recommendations for the advancement of the Health & Biosciences sector in Canada. Mr. Dybka

succeeds Paul Reider, who leaves Ipsen Canada to pursue other opportunities after three years with the organization, most recently as the General Manager for

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Ipsen Canada, where he led the organization through a number of Health Canada approvals bringing new innovation to patients with difficult-to-treat diseases.

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November/December 2018 Laboratory Focus www.laboratoryfocus.ca

feature

B y Ba ss am Hem dan

Five data management challenges

in genomics research labs

Back in 2010 the then-CEO of Google, Eric Schmidt, was quoted as saying

Moving the data

that every two days we create as much information as we did from the dawn of civilization up until 2003, which he figured was approximately five exabytes of data.

To put that into perspective, one exabyte (EB) of data is equivalent to one million

The first challenge customers experience is moving the genomics data. Not only is the size of the datasets an issue, so too is moving data from different storage layers by manual scripts — which often involves a team of IT administrators. First, the data needs to be moved out of the genomics sequencer into a high performance computing setup. From there, it needs to go into production storage and later into secondary storage for longer-term retention. Creating the manual scripts required to move the data from one stage to the next is time-consuming and expensive.

However, if this process were automated, the lab could not only save time but also reduce the number of employees it takes to do the job from a team to one IT admin. Automating the process also improves the accuracy of the data and avoids drop downs of manual scripts, which are less reliable because human error is inevitable. While there are no specific percentages of how much time is saved with automation versus manu-

terabytes (TB).

Take that and compare it to how much data a genomics research lab creates. For example, a small- to mid-sized research lab would have between three and five DNA sequencers — an instrument that converts a physical DNA sample into data. Each sequencer would generate 500-600 TB of data per year, which is equivalent to 0.0005-0.0006 EB or 0.0015 or 0.0018 EB for three sequencers and up to 0.0025 or 0.0030 EB for five sequencers. Worldwide there are now more than 2,000 next-generation sequencers and that number will continue to increase.

Because of the volume of data involved, many of the challenges surrounding genomics and data management derive from the technologies needed to store and analyze the raw

sequencing data. On top of that, the availability of deep and large genomic datasets raises concerns over who has access to what data, data security, as well as subject/patient privacy. These challenges can be broken down into five key areas that need to be addressed in order for the field to continue its rapid advances in medical and scientific research.

The following challenges are based on speaking to real-life customers where use-verification models were applied to mirror the data management process a genomics research lab would typically adopt. All of the customers identified these challenges and said a solution to automate the process would help in terms of time and cost savings.

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feature

al scripts due to the fact that each lab is different and the amount of data they handle varies, it is a very high percentage and the benefits far exceed moving the data manually.

Automation can be achieved with software that offers storage lifecycle management, making it easy to move the data in and out of secondary storage for when it might be needed in production to analyze or search the data, for example.

Understanding the data Once the data is where it needs to be, the second challenge is indexing the data in a repository so that it can be searched and analyzed. This process also requires manual scripts and can be improved with automation. Storage lifecycle management software offers indexing capabilities to make the data searchable in a virtual repository, which means that the lab doesn’t have to invest the time and money associated with moving it from a physical location. Instead, a virtual repository can be created and connected to indexing and reporting structures as well as analytics Application Programming Interfaces.

Sharing and securing the data The next two challenges are particularly important given the sensitivity and private nature of the data. How the data is shared and with whom it’s shared, without losing any of the data or failing to meet compliance regulations, is a significant challenge. An endpoint and edge solution can be added to allow data sharing with very high security and data protection levels, along with auditing/reporting to let the IT administrators know what they’re sharing, who they’re sharing it with and what levels of access each person has to that data.

As explained above, the virtual data repository can be connected to reporting structures, which gives IT administrators policy driven information about who has access to what data and what types of levels of access they have. This adds a high level of security and protection around the data if it can’t be backed up for some reason. Because of the extremely large size of the dataset, protecting that data without automation involves a significant investment in time, money and resources. However, by automating this process and linking it to the lab’s policies, data security can be streamlined, saving time and resources while preventing the data from getting into the wrong hands.

The first challenge customers experience is moving the genomics data. Not only is the size of the datasets an issue, so too is moving data from different storage layers by manual scripts — which often involves a team of IT administrators.

Pipelining the data The final challenge is data pipelining, in which the data is run through different levels of analysis from step to step. As outlined above, the first step is moving from the genomics sequencer to the high performance compute environment and then onto the production and secondary layers of storage, depending on what the lab is doing with the data at that particular point in time. With the data processed, the lab can get real-time notifications when certain steps in the pipeline process have been performed on that data. Once level one (as outlined in the first challenge) is complete, then the IT admin knows it’s time to proceed to the next step.

With one data management platform rolled out across the lab, IT administrators and researchers can address all the data management challenges. Depending what they already have in place, they can take all of the solution, including hardware and software, or parts of it as they need. Overall, the platform saves them time managing, developing and administering manual scripts. On top of that, they gain an added protection layer that will save them money on traditional backup.

The latter benefit is particularly pertinent for these labs as often these types of research institutions fully depend on public and private research funding and budgets, so they are looking to achieve their goals from a business and scientific standpoint with the least amount of cost.

The time saved also helps contribute to the bottom line as labs that have automated these processes for data can be more productive because they can depend on one admin looking after the entire process from a single screen.

Where is the PACS for genomics?

While these challenges can be addressed by a data management platform, there is still no equivalent for the genomics world like the picture archiving and communication system (PACS) system for the imaging world. Data management does bring

some sanity to the madness of the enormous genomics research datasets and the complexity that comes with them. Beyond these challenges, however, there’s still the question of cloud computing and what role it has to play in genomics research.

To date, most of the data in genomics research has been stored on premise due to the size and sensitivity of the data. But that doesn’t rule out the cloud completely. One of the main challenges is the size of the data sets — because you’re dealing with hundreds of terabytes or Petabytes of data, there’s an inherent bandwidth issue with upload and download times when it comes to moving data in and out of the cloud.

This is also quite a complex and costly exercise compared to moving data around on-premise. On top of that, storage isn’t cheap.

However, if storage consumption can be brought under control by a data management platform, then the workloads can be automated and managed from a single dashboard.

This makes it easier to move the data into production when needed for analysis and then back into secondary storage when it isn’t needed. In turn, this helps to optimize cost performance.

When it comes to sharing the data with other labs, one of the biggest challenges aside from those already mentioned is that unlike imaging data, which is used for diagnostic purposes, genomics data is used for research and varies from one institution to another. The process under which the data is collected, stored and analyzed is also more ad hoc compared to a unified system like a PACS in the imaging world. One of the key reasons for this is the genetic sequencers are siloed. Until this changes, there will always be components of the data gathering, management, storage and analysis that require an outside platform to connect them. The way in which the data can be interpreted also varies greatly compared with imaging data.

Genomics data can be used in a multitude of ways by different research institutes and organizations, meaning that a one-size-fits-all platform

won’t work in all cases and it needs to be configured on a case-by-case basis.

The future of genomics Although automation is tackling many of these challenges head on, there’s still a long way to go before genomics research labs can really reap the rewards that data management platforms promise. Many vendors are still looking at how they can take data management out to the market and apply it in a real world scenario.

The study of genomics in Canada is growing and this country is one of the leaders in the field. All of the main universities in Canada have research labs that are involved with genomics research. Canada is also recognized worldwide for Genome Canada, a not-for-profit organization funded by the Government of Canada and working to harness the power of genomics for the benefit of Canadians, including the fields of health, agriculture, forestry, fisheries and aquaculture, the environment, energy and mining.

As technology improves, so does our ability to gain better insights from the study of genomics and enhance the lives of people across Canada and around the world. But it’s important to remember that genomics data is only as strong as our capacity to manage it. Labs must find solutions that solve the five data management challenges in order to keep up with the rapid advances researchers are making in genomic science.

Bassam Hemdan is Vice President, Canada for Commvault, a global leader in backup, recovery, and data management across any hybrid environment

To see this story online visit https:// laboratoryfocus.ca/ five-data-managementchallenges-in-genomicresearch-labs/

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B y S t e v e n Ly nu m

How to Evaluate Your Next Ultra-Low Temperature Freezer Purchase: Caveat Emptor

The development of ultra-low temperature freezers spans decades of progress in component design, electronic supervision and cabinet construction.

F

rom refrigerants and compressors to controllers, cabinet insulation and data logging, manufacturers have established a myriad of internal operating metrics shaped to position their ultra-low temperature freezers as the best on the market.

In recent years, however, the industry-wide creation of ENERGY STAR® criteria for universal assessment of freezer performance has begun to bring credible, third-party insight into a reality that was previously left to manufacturers alone.

Today, facility and biorepository managers, along with end users, are

becoming more knowledgeable about key performance factors that ultimately define the suitability of an ultra-low temperature freezer for their application. As a result, the demand for independent testing and comparative evaluation of leading ultra-low temperature freezers on the market has grown, while purchasers have broadened their view of freezer specifications to evaluate the concept of performance at a higher level. This embraces three primary deliverables essential to stored product safety: reliability, recovery and energy efficiency. The first of these is reliability.

Reliability Because an ultra-low temperature freezer is acquired to safeguard years or even decades of clinical research at temperature setpoints of -80°C, or -70°C, failure is never an option. The value of frozen contents is difficult or even impossible to determine. Specimens are often irreplaceable. Therefore, uptime is the most important function of an ultra-low temperature freezer. It is also the single most challenging attribute that leads to uncertainty and impact on reproducibility in scientific research.

This chronic uncertainty weighs on the entire industry. The global repository of generations of research depends on the performance of a cold storage product group that, if not properly engineered, places inordinate stress on the machines as well as the people who place their life’s work inside.

In the life science market, there is no central agency to corroborate manufacturers’ claims of reliability, uptime and other performance attributes critical to safe storage of biological materials. Purchasers must depend on the integrity and social responsibil-

ity of the manufacturer, truthfulness of published specifications, referrals from colleagues and testing performed by their own institutions or by independent agencies.

Consultation with facility maintenance personnel responsible for outof-warranty service, or those who are factory trained and authorized to perform in-warranty service, can be highly credible sources of information.

Independent service repair companies with reputable service technicians are unlikely to recommend poor performing freezers in order to earn money fixing them; the stakes are too high. Whether in-house or independent companies, these insights can offer valuable context in advance of a purchase decision.

Recovery The exponential worldwide growth in the volume of stored frozen biologicals has brought forth a demand for better energy management. New cooling systems have established impressive statistics for reducing power requirements. These include cascade platforms with variable speed compressors as well as alternative

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engines. All must maintain ultra-low temperatures for indefinite storage while restoring setpoint temperature quickly and efficiently following door openings. Unfortunately, the need to reduce energy consumption has pushed some systems to the edges of prudent performance.

Temperature recovery requires a combination of system anticipation and rapid platform response within the parameters of a safe mechanical performance envelope. Thus, the freezer must be designed for the worst-case reality of daily operation where room temperatures can be high, line voltages may fluctuate due to aggregate power demands leading to brown-out conditions, and access to stored product may be more frequent than normal. The accumulation of frost on door gaskets and dust on condenser coils is another reality that engineers must confront.

While recovery and uniformity are related, recovery speed, which is a prime indicator of reserve refrigeration capacity and high ambient temperature tolerance, remains at the forefront of performance attributes.

Interior temperature recovery and uniformity are essential to the relationship between storage location and the viability of stored product over the long term.

A thorough evaluation of ultra-low temperature freezer purchase alternatives demands an understanding of recovery rates, measuring criteria such as ambient temperature at time of test, control probe location, duration of outer and inner door openings, and freezer load. Manufacturers who publish best-case recovery rates measured under ideal conditions may not account for actual use scenarios in their literature.

Independent documentation of recovery performance should be a prerequisite when comparing competitive freezers, and an essential consideration when purchasing any ultra-low temperature freezer whether for replacement or new laboratory design.

Energy Efficiency Development of more energy efficient ultra-low temperature freezers has continued to reveal significant improvements in the interplay between electronic sensors embedded within the cooling circuit, firmware with algorithms programmed to anticipate cooling demand, and cooling engines or compressors designed to remove heat from the cabinet to the outside environment. As a result, the power consumption gap between leading ultra-low temperature freezers from various manufacturers has narrowed.

Today, purchasers must emphasize reliability over initial acquisition cost.

An energy-efficient freezer that cannot respond to high ambient temperatures or cannot recover quickly following door openings neglects a key requirement for stable, long-term storage at ultra-low temperatures.

Purchasers must demand temperature recovery and uniformity more than insignificantly different energy costs.

And purchasers must demand a rebalanced performance equation where reliability, recovery and operating costs are properly apportioned to protect a priceless inventory.

An energy-efficient freezer that cannot respond to high ambient temperatures or cannot recover quickly following door openings neglects a key requirement for stable, long-term storage at ultra-low temperatures.

The industry-wide adoption of ENERGY STAR criteria for measuring and documenting power consumption has offered a new set of standards by which freezers can be evaluated. Energy consumption alone, however, should not be a primary performance attribute if achieved at the expense of recovery and uniformity.

As energy efficiencies continue to equalize, customers should expect energy savings over the life of the freezer that supersede the cost of operating installed freezers running on older conventional platforms. Most importantly, investments in energy efficient freezers should be made only within the context of why freezers are required in the first place: reliable, uni-

form and responsive ultra-low temperature storage of critical research.

Toward this end, purchasers should demand comparative data generated through independent evaluation of all products under consideration.

Through this effort, test conditions and criteria should remain constant across the board so that strengths and shortcomings can emerge in support of a purchase decision.

Laboratory compared three leading upright ultra-low temperature freezers under controlled conditions.

Summary

Steven Lynum is President, PHC Corporation of North America, formerly known as Panasonic Healthcare Corporation of North America, a subsidiary of PHC Holdings Corporation, Tokyo, Japan, which is a global healthcare company involved in the three core businesses of Medical Devices, Healthcare IT and Life Sciences.

While manufacturers’ specifications typically offer features and benefits, dimensions, site preparation and voltage requirements, the operation of an ultra-low temperature freezer in situ is best evaluated by a systematic review of third-party or internally commissioned testing independent from manufacturers’ claims.

An example of an internally commissioned comparison of ultra-low temperature freezers was presented at the International Society for Biological and Environmental Repositories (ISBER) 2018 Annual Meeting, Dallas, TX, “Comparison of Energy Efficient -80°C Freezers for Biorepository Storage.” Here, the Mayo Clinic Biorepository Program Biospecimens Accessioning and Processing (BAP) Core

This report is available from The Mayo Clinic or at https://www. morressier.com/article/5ada8 a0ed462b8029238e4de?utm_ source=laboratory-focus&utm_ medium=editorial&utm_ campaign=ult-freezers.

To see this story online visit https: //biotechnologyfocus.ca/howto-evaluate-your-next-ultralow-temperature-freezerpurchase/

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B y Herm an C. L am , P h.D

Electrostatic Powder Coating

for Pharmaceutical Applications

P

harmaceutical solid dosages such as tablets, capsules and pellets are often coated with a thin layer coating material for many purposes. Esthetically, the coating improves the appearance, market image and brand recognition of the products. The coatings also serve many practical functions such as ease of packaging, ease of swallowing and improved physical and chemical stability of the products.

Applying functional coatings on solid dosage forms is an important and versatile tool to modify the drug release profiles. There are many pharmaceutical products in the market with functional coatings for taste masking, odor masking, enteric release and extended release applications.

Pharmaceutical coating technologies have evolved over the years from sugar coating to solvent coating to more environmentally friendly aqueous coating. These coating processes are liquid based processes. For solvent coating, the polymeric coating materials are dissolved in the organic solvent for spraying onto the substrate. Polymeric materials are either suspended or dissolved in water for aqueous coating. Due to strict environmental regulations, aqueous coating has quickly replaced solvent coating for a majority of liquid coating processes except for some controlled released applications such as osmotic delivery and pellet formulations which still require solvent coating processes.

The major limitations associated with liquid coating processes are: • Microbial contamination in aqueous coating processes • Aqueous coating is not suitable for moisture sensitive drugs • Potential moisture related product stability issues of the finished products

• Expensive air handling systems are required to remove water vapor and solvents • Strict solvent emission regulations limiting the use of solvent coating processes

Electrostatic Powder Coating for Solid Pharmaceutical Dosage Forms Solvent free and water free powder coatings are desirable alternatives to overcome the short comings of liquid based coating. A patented electrostatic powder coating technology for pharmaceuticals was invented

by Professor Jesse Zhu at Western University after over two decades of research in powder coating.1-6 The technology utilizes pharmaceutically acceptable materials and a combination of electrostatic force, thermal energy, hydrodynamic force from the powder spray and mechanical energy from the rotation of a coating pan to coat pharmaceutical substrate directly with dry powder. The electrostatic powder coating technology has overcome the major technical challenges facing pharmaceutical powder coating to make the coating process amendable for commercial use. The challenges include powder flow, reduction of glass transition temperature of the polymer used and powder adhesion to the substrate and curing to form a uniform coat.

The electrostatic powder coating process is shown schematically in Figure 1. The substrate is loaded into a pan coater and pre-heated to approximately 60°C. A suitable plasticizer is sprayed onto the substrate to lower the glass-transition temperature of coating polymer to soften it and facilitate powder adhesion on the substrate. Ultrafine powder is sprayed onto the substrate using an

electrostatic spray gun. The coating pan is grounded to create a potential difference leading to electrostatic attraction between the substrate and the charged powder. The coated substrate cures at a temperature slightly above the glass-transition temperature of the polymeric coating material to form a uniform film coat.

Many commercially available pharmaceutical coating materials from major coating materials suppliers such as Evonik, Colorcon, Dow Chemical and Kodak for controlled release applications have been successfully applied on tablets, HPMC capsules and pellets using the electrostatic powder coating technology.

Immediate release coating materials include Eudragit® EPO (taste masking), as well as Opadry® II and Opadry® AMB (moisture barrier). Enter-

Figure 1

ic release coating materials include Eudragit® L100 and Acryl-EZE® MP. Extended release coating materials include Eudragit® RL100 and Eudragit®RS100, ETHOCEL™ and Cellulose Acetate from Kodak (Omotic delivery devices). Other coating materials to target drug release at the lower GI track can also be used in the electrostatic powder coating.

A comparison of powder coating and liquid coating for pharmaceutical applications is shown in Table 1.

Key advantages of powder coating are listed below.

1. Avoid moisture related problems 2. Energy efficient and environmentally friendly 3. No need for expensive exhaust equipment and air handling system to remove water vapor or solvent. The equipment and facility

Electrostatic Powder Coating Process

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Feature Table 1 Comparison between Powder Coating and Liquid Coating Key Comparators

Powder Coating Aqueous Coating Solvent Coating

1Operating costs Low Low High Facility costs Low

Medium High

Environmental impacts Low Low High Functional release coatings Immediate/extended Immediate/extended Immediate/extended

Examples of Powder Coating for Controlled Release Applications

Coating thickness homogeneity Good/Better Good Good Ease of use Easy Easy

Complicated

Water sensitive drugs

Compatible

Compatible

Non-Compatible

Processing time Short Short Long Pellets coating Pan coater Fluid bed coater Fluid bed coater Risk of microbial contamination Low High Low

Table 2 Coating uniformity based on amount of titanium and Magnesium ions detected using Laser Induced Breakdown Spectroscopy (LIBS) Lot # Ibuprofen tablets Titanium Signal Intensity Inter-site RSD (%) Intra-site RSD (%) 1 Powder coated (Eudragit EPO)

30

3.6

14

2 Powder coated (Acryl-EZE MP)

241

2.7

20

3 Powder coated (Eudragit L100-55)

26

6.2

18

2074

14

13

4

Marketed ibuprofen product

costs are significantly reduced.

4. Opens up new possibility of using powder coating to the development of controlled release formulations that traditionally requires solvent coating.

Figure 2

Quality The use of ultrafine powder in electrostatic powder coating enables the formation of smooth coatings comparable or smoother than liquid coating processes. The amount of coating ma-

Dissolution Profile of Powder Coated Aspirin Tablets and Capsules

profen product. The Relative Standard Derivation (RSD) of the measured intensity at various locations and depths were compared. The results are shown in Table 2. The intertablet variation of the powder coated tablets is better than the commercial product. The intra-site variation of the powder coated tablets is comparable with the commercial product.

terial deposited on the substrate; and hence, the thickness of the coating, can be controlled by the electrical voltage setting of the powder spray gun. The electrostatic repulsion of the charged powder particles promotes even distribution of the powder on the surface to form a uniform smooth coating.

The coating uniformity of powder coated tablets with different coating polymers has been studied using Laser Induced Breakdown Spectroscopy LIBS. The coating materials usually contain titanium dioxide and sometime magnesium stearate. Upon vaporization by a laser, the titanium and magnesium form excited ions which emit photons. The emission intensity is related to the amount of titanium and magnesium in the coating.

By measuring the variability of the ion intensity from different locations or depths of the tablets, the variation of the coating thickness and uniformity can be assessed.

Three ibuprofen tablet batches were coated with three different types of functional coating polymer for taste masking, enteric release and extended release.4 The LIBS data of the three powder coated batches were compared to a marketed ibu-

Example 1: Powder coating for enteric formulations Enteric coating is insoluble in low pH and allows coated tablets and capsules to pass through the stomach without releasing the drug. The coating helps to protect the acid labile drugs from hydrolysis by the stomach acid and prevent stomach irritation caused by drugs such as Aspirin. Aspirin tablets and HPMC capsules containing Aspirin (81 mg and 325 mg strengths) have been successfully coated with Eudragit® L100 - 55. The dissolution profiles of the enteric coated Aspirin tablets and capsules and the commercial Bayer Aspirin Tablets are shown in Figure 2. The powder coated tablets and capsules meets the USP dissolution requirement of less than 10% release during the acid stage testing.

Example 2: Powder coating for small pellets Small pellets pass through the GI track at a steady pace which is very desirable for controlled release applications. Also, multiple coating layers for different functions can be applied on the pellets successively (Figure 3a). Piroxicam pellets with a particle size of 0.9–1.18 mm have been successfully coated in a pan coater with Eudragit® L100 – 55, Eudragit® EPO and Eudragit® RS/RL for enteric release, taste masking and extended release applications respectively.

The dissolution profiles of the pellets with the three different polymers are shown in Figure 3b. It is worth noting that coating of small pellets usually requires the use of a fluid bed coater to suspend the pellets in mid air to prevent pellet cohesion.

Example 3: Powder Coating for Osmotic Drug Delivery Systems Osmotic Drug Delivery Systems are the only true zero order release delivery system and the drug release is independent of food intake. Cellulose acetate has been successfully applied by powder coating onto an osmotic tablet core containing salbutamol to form a semi-permeable coat for osmotic delivery applications. The resulting osmotic delivery system and the dissolution profiles are shown in Figure 4. It is noteworthy that solvent coating is typically

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feature Figure 3 3a

lets with Eudragit (R) RS/RL using a novel electrostatic dry powder coating process, Int. J. Pharmaceut. 399 (2010) 37–43.

4. J. Zhu, M.X. Qiao, Y.L. Ma, K. Chow, A method for electrostatically powder coating tablets, Tablets and Capsules, 2010 5. M.X. Qiao, L.Q. Zhang, Y.L. Ma, J. Zhu, W. Xiao, A novel electrostatic dry coating process for enteric coating of tablets with Eudragit (R) L100-55, Eur. J. Pharm. Biopharm. 83 (2013) 293–300.

6. Y. L. Yang, Y.L. Ma, J. Zhu, Applying a novel electrostatic dry powder coating technology to pellets, Eur. J. Pharm. Biopharm. 97 (2015) 118–124.

3b

Figures: 3a: Multiple Coating Layers for Pellets 3b: Dissolution Profiles of Powder Coated Piroxicam Pellets with Eudragit® L100 – 55, Eudragit® EPO and Eudragit® RS/RL

Figure 4

Powder Coated Osmotic Delivery System and Dissolution Profiles required for coating osmotic polymers such as cellulose acetate.

Summary Electrostatic dry powder coating is a promising technology to replace liquid coating for many pharmaceutical applications.

References: 1. J. Zhu, Y. Luo, Y. Ma, H. Zhang, Direct Coating Solid Dosage Forms using Powdered Materials, US Patent 8161904 B2, 2007.

2. M.X. Qiao, L.Q. Zhang, Y.L. Ma, J. Zhu, K. Chow, A novel electro-

static dry powder coating process for pharmaceutical dosage forms: immediate release coatings for tablets, Eur. J. Pharm. Biopharm.

76 (2010) 304–310.

3. M.X. Qiao, Y.F. Luo, L.Q. Zhang, Y.L. Ma, T.S. Stephenson, J. Zhu, Sustained release coating of tab-

Herman Lam was a Principal Investigator at GlaxoSmithKline Canada. Currently, he is the CEO of Powder Pharma Coating Inc. Dr Herman Lam received his B.Sc. from the University of Toronto and his Ph.D. in chemistry from York University in Toronto. He was a Principal Investigator at GlaxoSmithKline Canada responsible for the implementation of new analytical technologies and laboratory automation. Currently, he is the CEO of Powder Pharma Coating Inc. Dr Lam also serves as the President of the Calibration & Validation Group (CVG), a government registered non-profit professional organization in Canada with focus on the GMP, calibration and validation in pharmaceutical industry.

He was appointed Honorary Assistant Professor in the Department of Chemistry at the University of Hong Kong from February 2012 to 2015. He is an Adjunct Associate Professor at the School of Pharmacy of the Chinese University of Hong Kong.

To see this story and all the figures online visit https:// laboratoryfocus.ca/electrostatic-powder--coating-forpharmaceutical-applications/

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B y R e n é P. Z ah e di a nd C hri s t o p h H . B o r c he rs

Proteogenomics as an approach to improve cancer treatment

I

n recent years, precision medicine has opened new avenues for the targeted treatment of cancer (or other diseases), using the best available therapy. Upon identification of somatic genetic alterations (point mutations, deletions, amplifications, etc.), specific drugs can be selected that allow the targeted treatment of a tumour.1 Genomics-based precision medicine has been successfully applied to heal cancer patients by ensuring that each patient receives the optimal treatment, but response rates are still often unexpectedly low. For some cancers, up to 50 % of patients may not respond to the predicted targeted drug treatment.2 A variety of reasons contribute to these modest success rates. One reason is that the genome defines only the potential template of an organism (its genotype) and is rather static, while biological processes are highly dynamic.

This dynamic is controlled not only by those biomolecules that are encoded in the genome (i.e., proteins), but also by metabolites and lipids.

The proteome is defined as the complement of all proteins expressed by an organism, tissue or cell at a given time point and condition. Its composition depends not only upon which genes are active (i.e. protein translation), but also protein degradation and post-translational modifications that alter the structure of the protein and therefore its function and activity. Thus, the proteome of an organism reflects of the actual state of the organism (its phenotype) more accurately than does the genome, and the proteome depends on a multitude of factors: environment, diet, age, gender physical activity, health status, medication, etc.

To understand the causes as well as the consequences of disease on a molecular level, it is essential to understand which genes are actually

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feature agglomerate of multiple cell types (cancerous and healthy), not every predicted mutation is actually present or relevant.

• How many copies of each protein are really present in the tumour?

Depending on the protein, the copy number can vary from a few to a several million molecules per cell and copy number is often changed in tumours compared to healthy cells or tissues. Such changes can indicate increased or reduced activity of central pathways, and these changes are not readily predictable from the genome.

• Are protein activities or signalling pathways altered? Dysregulated signalling (protein phosphorylation) is one of the main causes of cancer, and many drugs target tyrosine kinases.5 Protein phosphorylation levels and alterations, however, cannot be predicted from the genome.

Genomics-based precision medicine has been successfully applied to heal cancer patients by ensuring that each patient receives the optimal treatment, but response rates are still often unexpectedly low. For some cancers, up to 50 % of patients may not respond to the predicted targeted drug treatment.2 being actively translated into proteins, which are the real drivers of biology.

Indeed, genomics will fail to distinguish the tadpole from the frog.

Although these two are very distinct stages (phenotypes) in the life cycle of the very same organism, they share an identical genome but can be clearly differentiated by their proteomes. In a similar way, in many cases, the molecular basis of an individual cancer cannot be completely understood by using only genomic approaches. Therefore, the combination of genomic data with quantitative proteomic data on both

protein expression and post-translational protein modifications – a novel approach termed proteogenomics3 – is now thought to be a very promising approach for improving precision medicine so that it better predicts individualized treatment for cancer patients. This unique combination will enable researchers and clinicians to address several fundamental questions: • Which genes and mutations are actually active and are being translated into proteins in a tumour? Although a tumour cell contains more than 10,000 different proteins4 and tumours are an

Proteogenomic analysis of tumour biopsies holds the unique potential to allow researchers and clinicians to fully understand the molecular basis of an individual tumour by combining precise information on its genotype and its phenotype. Ideally, this will allow clinicians to select the best available treatment strategy, or to develop new treatments that not only effectively kill all of the cancer cells, but also prevent relapse.

At the Segal Cancer Proteomics Centre, we have already begun to translate our proteogenomics strategy into the clinic. We have extensively analyzed colorectal cancer tumour specimens using state-of-the-art proteomics technologies based on nano-LC-MS/MS using a non-targeted “shotgun” approach which provides an unbiased identification and quantification of proteins. This has enabled the high confidence identification of more than 8,000 proteins from individual tumours. Aligning this data with the corresponding genomic data from the same tumour samples (the genotype), has allowed us to clearly verify the presence of predicted mutations within the tumour on the protein level (the phenotype). Using this approach, we have been able to verify the presence of known driver mutations, such as KRAS G12V, in the tumour samples.

After the specific mutation has been verified, we were then able to develop very sensitive targeted mass spectrometry assays which allow us to determine the actual level of that mutation in individual tumours using absolute quantification methods with high sensitivity and precision. Our goal is to provide unique

molecular signatures for individual tumours. This will allow us to better define why specific patients do not respond to treatments predicted based on their genomic profiles, and thus improve the selection of appropriate treatment strategies.

References 1. Letai A. Functional precision cancer medicine-moving beyond pure genomics. Nat Med. 2017;23(9):1028-35.

2. Heist RS, Christiani D. EGFRtargeted therapies in lung cancer: predictors of response and toxicity. Pharmacogenomics.

2009;10(1):59-68.

3. Boja ES, Rodriguez H. Proteogenomic convergence for understanding cancer pathways and networks. Clin Prot.

2014;11(1):22.

4. Bekker-Jensen DB, Kelstrup CD, Batth TS, Larsen SC, Haldrup C, Bramsen JB, et al. An Optimized Shotgun Strategy for the Rapid Generation of Comprehensive Human Proteomes. Cell Systems. 2017;4(6):587-99.e4.

5. Cohen P. Protein kinases--the major drug targets of the twenty-first century? Nature Reviews Drug Discovery. 2002;1(4):30915.

Dr. Christoph H. Borchers is a professor at both the University of Victoria and McGill University, and director of the proteomics centres at both universities. Dr. Borchers’ expertise includes the improvement, development, and application of proteomics and metabolomics technologies, with a major focus on techniques for quantitative proteomics and metabolomics for clinical diagnostics.

Dr. René P. Zahedi is the Associate Director of the Segal Cancer Proteomics Center at McGill University. His research has focused on the mass spectrometrybased detection and quantitation of post-translationally modified proteins, with an emphasis on cancer-related signalling pathways and diagnostics.

To see this story online visit https://laboratory focus.ca/proteogenomics-asan-approach-to-improvecancer-treatment/

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November/December 2018 Laboratory Focus www.laboratoryfocus.ca

New Products Vacuum ovens

The BEING line of Vacuum Ovens offers a variety of sizes to fit the unique needs of the users. Due to design, the BEING vacuum oven offers more usable space than similarly sized ovens. A large viewing window allows the user to quickly view their samples from a distance. The BEING controller offers superior temperature control and safety features.

Features Include: • Easy to read color LCD display.

• Real-time display of measured vacuum helps the user to monitor the progress of the drying sample • Inert Gas Inlet • Interior Chamber made from 304 stainless steel with a mirror polished finish making for easy cleaning • Adjustable shelves for added flexibility to accommodate various size containers • Exhaust valve switching and pump switch comes with an electromagnetic valve controller which is safe and reliable.

• User-friendly and reliable operation while at the same time conserving vacuum pump power • The BEING Controller provides programmability for 7 periods and 9 steps for each period making for a total of 63 programmable steps The BOV series consists of three models. The chamber sizes are 0.9 cu ft, 1.8 cu ft, and 3.2 cu ft. The temperature range is from 10° C above ambient to 200° C.

www.beinglab-usa.com/vacuum-oven-200/.

Liquid Biopsy Test Roche announces the global availability of FoundationOne Liquid, a liquid biopsy test. Many cancer patients have an insufficient or inadequate tissue for genomic testing and may therefore benefit from FoundationOne Liquid. This new test joins FoundationOne CDx to deliver a complementary portfolio which provides insights to personalise a patient’s treatment plan. FoundationOne Liquid can identify circulating tumour DNA in the blood of people living with cancer and can identify 70 of the most commonly mutated genes in solid tumours, including microsatellite instability, a genomic signature which may help inform cancer immunotherapy-based treatment decisions. From a single blood sample, the liquid biopsy offers a quick and convenient option for some patients with solid tumours. FoundationOne Liquid meets a need for comprehensive genomic profiling for people who have an insufficient or inadequate tissue, including those with advanced non-small cell lung cancer, where an estimated 15 per cent of patients are not eligible for tissue biopsy and approximately 10 per cent have a biopsy size that is insufficient to evaluate. FoundationOne Liquid works well with FoundationOne CDx, a tissue-based genomic profiling test launched in the US earlier this year, to deliver a portfolio of comprehensive genomic profiling services for healthcare professionals.

www.roche.com/products/product-details.htm?productId=9f2fe5f0baf4-434f-9bca-1e03c8c2b6e1

Mobile real-time PCR System Ubiquitome Limited launches the Liberty16 at the American Society of Human Genetics conference, the latest product in its range of mobile real-time PCR systems. Designed to give users access to mobile, cutting-edge DNA testing, the Liberty16 offers DNA quantitation capability whenever and wherever it’s needed.

The Liberty16 starts at $1,500, and Ubiquitome is taking pre-orders from researchers on a “first-come first-served” basis for the device at http://www.ubiquitomebio.com/Liberty16preorder.

The Liberty16 comes with built-in lithium-ion batteries for two to three hours of mobile running time, as well as Bluetooth paired with an iPhone app that means you can run your samples anywhere. The device is sized to fit with whatever space a researcher must work with and is easily transported from site to site. It acts as a personal qPCR device that: • Offers great quality and value • Fits easily into your workspace • Comes with a sliding lid so samples are easy to load • s light, compact and easy to move around • Is designed for individual use, meaning you can test samples without waiting An open platform, the Liberty16 is compatible with industry standard consumables and chemistries such as Taqman®and SYBR® and comes in a sleek, robust, easy-to-clean package.

http://www.ubiquitomebio.com/

DNA Sequencing kit The QuantideX NGS DNA Hotspot 21 Kit is an in vitro diagnostic, nextgeneration sequencing (NGS) panel for the detection of clinically relevant variants across a multitude of tumour types, including non-small cell lung cancer, colorectal cancer, and melanoma. The kit screens for over 1,500 known genomic variants, including single nucleotide variants (SNVs), insertions/deletions (indels), and structural rearrangements, many of which are treatable with novel therapies, inform on patient management, or are the subject of further clinical evaluation. The panel provides a robust and reliable NGS solution for the identification of clinically relevant targets. The QuantideX NGS DNA Hotspot 21 Kit combines Asuragen’s unique NGS-in-a-Box solution with a streamlined testing workflow to enable unprecedented NGS workflow efficiency and high sensitivity at low input amounts from precious FFPE samples.

Reduced Complexity Assay incorporates sample-to-data solutions in a unique NGS-in-a-Box™ configuration • Detects >1,500 variants from commonly mutated genomic regions across multiple tumour types • End-to-end kitted solution • Fully integrated data analysis pipeline Optimized Workflow Provides operational efficiencies to reduce testing costs, hands-on and total turnaround time • Reduced labour required for library preparation • Improved turnaround time enables higher throughput • Common workflow across portfolio streamlines training & implementation Quality Performance Highly sensitive assay with integrated, Sample-Aware bioinformatics software and built-in quality checks to minimize erroneous results and sample failures • Highly sensitive detection of DNA-based variants • Low input (~20ng) of DNA from FFPE • Sample-Aware bioinformatics analysis and sample quality control

https://asuragen.com/portfolio/oncology/quantidex-ngs-dna-hs21/

www.laboratoryfocus.ca

19

Laboratory Focus November/December 2018

app review DNAApp: DNA sequence analyzer

https://play.google.com/store/apps/details?id=bii. seqdatreader&hl=en This is the first android app that allows for the opening and analysis of DNA sequencing files - ab1. It includes handy tools such as “Reverse Complement”, “Jump to”, fast and end scrolling, “Chromatogram adjustments”, amino acid translations, “export to fasta”, and “searching for segment” function. This app works with cloud storage access like Dropbox to your sequencing files.

A society in transition The cannabis industry has exploded this past year in prep for the now national legalization of marijuana. This has caused an influx of companies – producers and affiliated parties – to seek the smoky trail that will bring them to the forefront of the cannabis market.

According to the Canadian Marijuana Index, the value of cannabis stocks has risen nearly tenfold over the past two years. As well as that, there have been multiple mergers and acquisitions as companies fight for the top spot that keep investors eyes firmly set on the Canadian market.

With expectations of the cannabis market to grow larger than the hard liquor market, it should come as no surprise that there are many companies jumping on the bandwagon to plant their seed in an advantageous spot. There are now some two dozen publicly-traded marijuana companies with an estimated combined market value of $23-billion. With this only expected to rise, it will be interesting to see what happens in this lucrative market.

Canadian consumers expect high-quality product, and depending on the province, will be offered online or in government-run stores. Undoubtedly the demand will change depending on location and product offered.

This ground-breaking transition is complex, and every detail needs to be intricately balanced. Public safety and privacy is paramount. However, this opens many doors for entrepreneurs and fosters innovation that can be a positive contributor to the national economy as Canada takes a leadership role in making Canada the first G7 country to legalize recreational cannabis nationally.

artis

https://play.google.com/store/apps/details?id=com.thermofisher.mobile.android.artis&hl=en The artis mobile app brings together a powerful set of leading-edge scientific content—including how-to videos, on-demand webinars, application notes and white papers—all in one convenient, mobile friendly location. Find content by application area such as molecular biology and dive deeper into sub-areas such as nucleic acid quantitation. Receive the latest content without ever having to update—new content is uploaded periodically and automatically adds to your app.

Instrument Connect

https://play.google.com/store/apps/details?id=com.thermofisher.icma_android&hl=en Instrument Connect remotely monitors instruments in real-time. Stay connected to cloud-enabled instruments and benchtop devices anytime, anywhere, using the Instrument Connect mobile app. With the Instrument Connect remote monitoring app powered

by Thermo Fisher Cloud, you can stay connected to any Thermo Fisher Cloud-enabled instruments, including the Applied Biosystems QuantStudio 3 and 5 realtime PCR instruments, and the ProFlex and SimpliAmp end-point PCR devices.

New accessory: Eppendorf ThermoTop®

Multiple Talents Eppendorf ThermoMixer® and Eppendorf ThermoStat™ The new generation of Eppendorf Temperature Control and Mixing Instruments offer you more than what meets the eye.

Not only do they provide versatility and accurate temperature control, they now also offer you superior mixing performance, outstanding ergonomic operation and a unique ThermoTop.

> 2DMix-Control: perfect mixing results in all vessel formats > Eppendorf QuickRelease: ergonomic block exchange in just 2 seconds > Intuitive operation: pre-optimized program and temperature keys > Eppendorf ThermoTop prevents condensate formation for more accurate results

www.eppendorf.com/thermomixer-c • 800-263-8715 007.A1.0105.A Eppendorf®, the Eppendorf Brand Design, Eppendorf ThermoMixer®, and Eppendorf ThermoTop® are registered trademarks of Eppendorf AG, Germany. ThermoStat™ is a trademark of Eppendorf AG, Germany.

All rights reserved including graphics and images. Copyright © 2018 by Eppendorf AG.

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