Lab Business January/February 2017

One-Stop Repairs

David Suzuki Learning from nature

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The Definitive Source For Lab Products, News And Developments

www.labbusinessmag.com

January/February 2017

Medical device manufacturers save time and money

17

Mastering

Mentorship Sanofi Biogenius Canada finalist gains research experience at a Toronto lab while her mentors gain much more

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CONTENTS 10

A Passion for Stem Cell Research

We Can Learn so Much from Nature

By David suzuki

Biomimicry can inspire technologies based on nature’s ability to solve problems and exploit opportunities.

One-Stop Repairs

By Dick Puhl

Medical device manufacturers can speed repairs and reduce costs by working with a single source for machine repairs.

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By Hermione Wilson

With some great mentorship, Sanofi Biogenius finalist Miranda Li has turned a passion for biotechnology into a possible career.

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standards

Do the flip!

Learn how wage subsidies and an underutilized talent pool can drive innovation in bio.

guest editorial 5

regional profile

Exploring BC’s $14B life sciences sector 13

Canadian news 6

Learning from nature

9

ManagMent

Running online customer advisory boards 17

feature

New developments in suicide gene therapy 21

jaNuaRy/fEBRuaRy 2017

One-StOp RepaiRS

DaviD Suzuki The DefiniTive Source for Lab ProDucTS, newS anD DeveLoPmenTS

www.labbusinessmag.com

January/February 2017

Medical device manufacturers save time and money

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Championing the Business of Biotechnology in Canada

Mastering

Mentorship

Lab ware 20 moments in time 23

on twitter at @biolabmag

Sanofi Biogenius Canada finalist gains research experience at a Toronto lab while her mentors gain much more

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suzuki matters

January/February 2017

Hiring Fair Only 7% of Canadian biotechs employ persons with disabilities

On the Web at www.labbusinessmag.com

@

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Gain A Foothold In The Food And Beverage Industry For more than 30 years Bio & LAB Business has engaged the Canadian science community, put forth award-winning editorial, connected advertisers and developed an extensive network of partnerships and media sponsorships.

Canadian Food Business is now building on the strengths of the Bio & LAB Business sister publication, ensuring our magazine is in the right hands.

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Here Comes the Wrecking Crew by

serving canadian laboratories and lab suppliers since 1985

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Robert Price

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oo bad for Betsy DeVos. If only she had done her homework, she might not have made such a fool of herself.

DeVos, as most people know by now, is Donald Trump’s nominee for Secretary of Education. DeVos has no experience as an educator and little direct contact with public education. Neither she, nor her children, attended public school.

But she is a billionaire. And she has donated hundreds of millions of dollars to the Republican Party. For America’s pyrite president, that’s enough to qualify her to formulate education policy for the nation. At the Senate confirmation hearing, DeVos revealed how remarkably unfit, uninformed, and unprepared she is for the job of top educator. Senators learned DeVos is unaware of rules related to education funding, uneducated on major pedagogical debates of the day, and “confused” about laws protecting disabled students.

Teachers should be able to bring guns to school, she told senators. In case of bear attacks.

Trump has made a calculated choice in choosing DeVos to run America’s schools. She has zero experience and little knowledge of public education. That’s the point. In DeVos, as with his many other cabinet picks, Trump is appointing a wolf as shepherdess.

This is the logic of the mutinous right. Historian and writer Thomas Frank calls these people “the Wrecking Crew.” They gain public office to dismantle public office. They break government programs so they can “fix” them.

Stephen Harper acted in a similar way. Faced with a budget surplus in his first term, Harper made cutting the HST one of his first acts as prime minister. This cut drove government into deficit, allowing Harper to announce he needed to cut programming to balance the books.

Expect Trump to employ this familiar tactic—although he will, as is his style, take everything too far. He’ll urinate on the bed, say it’s wet, throw it from the penthouse balcony, and purchase a new one—gold plated—from Trump Inc. The goal is undoing what has been done. Reports float in the media that Trump will eliminate the National Endowment for the Arts, defund the National Endowment for the Humanities, and make America’s national parks open to resource extraction. Goodbye public broadcasting. Adios climate change research. From all Trump has said, this does not sound entirely like fake news. It’s what the wrecking crew does.

At the time of this writing, scientists are still waiting to learn how Trump will treat statefunded scientific research. The early word is not good. Congressman Mick Mulvaney, who will write Trump’s budget, mused on Facebook about government-funded research. Why fund research into Zika virus? Who needs environmental research? Why bother?

If that didn’t give empiricists a sense of what’s to come, Trump borrowed a dirty maneuver from Harper’s approach to government: muzzling scientists. He moved quicker than Harper did, forbidding staff at the Environmental Protection Agency from speaking to the media on his third day as president.

While Trump may take a technocratic approach to government—funding only research that’s good for business—he has surrounded himself with evangelicals, climate deniers, creationists and buccaneering businesspeople. Not good for science.

And if Trump tears up NAFTA, Canadian businesses will suffer, since 75 per cent of Canadian exports head south.

The wrecking crew. The right makes the same claims about the left. To conservatives, Obama’s progressive politics have resulted in, as Trump said at his inauguration, “American Carnage.”

Carnage? Another dishonest Trumpian exaggeration. Regardless, the left is out of power, at least in America, where so much business and scientific momentum originates.

We gape at the U.S. because the unregulated right, the wrecking crew, is now fully empowered to refashion America.

What begins with appointing unqualified billionaires to key public offices leads to cuts, then bleeding, then hurt. Not just for Americans. For everybody.

Robert Price is the former Managing Editor of this publication. Follow him @pricerobertg. www.labbusinessmag.com

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Canadian NEWS Supporting Innovation

Innovation 150 Ramps Up

The new $20-million Colleges Applied Research and Development Fund (CARDF) announced by Ontario Premier Kathleen Wynne will promote new economic growth, the Ontario Centres of Excellence and Colleges Ontario says. The fund was officially launched late January at Conestoga College. It is part of the Ontario government’s Business Growth Initiative and will be coordinated through a partnership between the Ontario Centres of Excellence (OCE), Colleges Ontario and the Ministry of Research, Innovation and Science (MRIS). The fund will encourage public-private partnership between colleges and Ontario businesses that will drive innovation, research and development.

It will also provide unique experiential learning opportunities for college students.

HIV Therapies Could be Contributing to Syphilis Outbreak

I

n 2017, Canada celebrates its 150th anniversary of Confederation.

Innovation150 was selected by the Department of Canadian Heritage as one of several Canada 150 Signature Initiatives, highimpact national projects that build a sense of pride and attachment to Canada.

Innovation150 is a nationwide program from five leading science organizations that celebrates Canada’s innovative past and Innovation150 is a nationwide sparks the ideas and ingenuity program from five leading that will propel our future. science organizations that The interactive, year-long celebrates Canada’s program offers awe-inspiring experiences in science, techinnovative past and sparks the nology, and innovation across ideas and ingenuity that will the country for Canada’s 150th propel our future. anniversary. Innovation150 engages Canadian youth, families, and communities across the country through travelling science exhibitions, a mobile makerspace, innovation festivals, a digital storybook, and more.

There are more than 100 events, 60 communities to tour, 35,000 km to travel, six festivals, and 400 stories of innovation.

Partner organizations include the Perimeter Institute, Actua, Institute for Quantum Computing, Canadian Association of Science Centres, and Canada Science and Technology Museums Corporation.

Find out more at https://innovation150.ca/about.

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January/February 2017 Lab Business

Drugs used to treat HIV could affect how the body responds to syphilis, inadvertently contributing to a current outbreak, a new UBC study suggests.

Syphilis cases in several countries have risen sharply in recent years, primarily affecting men who have sex with men. In this study, researchers investigating the outbreak hypothesize that medications used in highly active antiretroviral therapy (HAART), the gold standard for treating HIV infection, could reduce the body’s immune responses to particular diseases, including syphilis.

As a next step, researchers will need to look more closely at the relationship between HAART and infectious and non-infectious diseases and whether there are specific drugs in the HAART medication cocktail that impair immunity.

ACOA Renews Springboard Funding

Springboard Atlantic, the not-for-profit network that drives the commercialization of academic research in Atlantic Canada, will receive $9.2 million from the Atlantic Canada Opportunities Agency (ACOA) Atlantic Innovation Fund (AIF). Springboard’s 19 member institutions play a significant role in corporate research and development. More than 20 per cent of all private sector R&D in Atlantic Canada is conducted in partnership with post-secondary institutions compared to five per cent in the rest of Canada.

Over the past 10 years, Springboard has helped create 126 new companies and generated more than $12 million in licensing and royalty income. The AIF helps Atlantic Canadians develop and bring to market new products and services that lead to market success, help grow strategic sectors, or lead the creation of research and commercialization partnerships.

Worldwide NEWS

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New White Paper Presents Latest Developments in Mass Transfer and Storage to Support Redefinition of the Kilogram for 2018

he NewKILO JRP, a three-year project of the European Metrology Research Programme (EMRP) involving 13 National Metrology Institutes (NMIs) and co-funded by the European Union (EU), was completed in May 2015. The future definition will require the unit of mass to be realized in a vacuum, instead being maintained and used in air, which presents some challenges to establishing traceability to the mass scale.

This white paper describes the research undertaken in relation to storage, transport, and transfer of mass standards between air and vacuum, which is critical in establishing traceability of new methods under vacuum to existing methods in air, and dissemination of the kilogram after the redefinition in 2018.

In parallel, Mettler Toledo has developed new apparatus to enable the transfer of artefacts to the M_one mass comparator under a controlled atmosphere (such as vacuum or inert gas), preventing air contamination.

This apparatus consists of an Artefact Transfer Device (ATD) and an Artefact Storage and Transport Vessel (ASTV). The ASTV is made of high-grade stainless steel and can accommodate a range of 1 kg weight types, including Pt-Ir cylinders, silicon spheres, and stainless steel OIML shaped or cylinder weights, without the need for adapter plates.

Automated Gravimetric Centering (AGC) ensures correct positioning, minimizing eccentricity and ensuring the highest possible repeatability.

The M_one mass comparator, with a resolution of 100 nanograms and a typical repeatability of 300 nanograms, enables NMIs to achieve the most accurate results for weights calibration, with the smallest possible measurement uncertainties, in the shortest time. External influences are reduced to a minimum using vacuum technology, which enables measurements under a controlled environment from ambient pressure down to a vacuum of 10-6 mbar (10-4 Pa).

As the future definition of the kilogram will be measured in a vacuum, the M_one mass comparator, along with the Artefact Transfer Device (ATD) and Artefact Storage and Transfer Vessel (ASTV), enable transfer of an artefact from one piece of apparatus to another whilst keeping it constantly under vacuum. These devices will play a vital role in current and future research to support the redefinition of the kilogram project, including dissemination of the new kilogram following the redefinition in 2018.

Mettler Toledo is proud that M_one technology is leading the way to a higher level of weighing accuracy in current research to redefine the kilogram. To learn more about the M_one’s role in the effort, or to discover how an NMI, governmental, or research organization can obtain this specialized technology, download the free white paper.

This white paper will be relevant to National Metrology Institutes (NMIs), Weights & Measures and private calibration laboratories, weight manufacturers, and metrologists. It is also aimed at those with an interest in progress to redefine the kilogram, subsequent traceability to the mass scale, and the latest developments in storage and transfer technology for mass standards to support this research.

Supporting Mainstream Adoption of Quality by Design

Sartorius Stedim Biotech (SSB), a supplier for the biopharmaceutical industry, has developed an innovative and fully integrated technology platform to meet the requirements of today’s upstream bioprocessing. It will allow customers to adopt a Quality by Design (QbD) approach in which they build quality into their biological products by combining the power of high-throughput mini bioreactors with data analysis and knowledge management tools so that robust and well-characterized processes can be scaled up at the first attempt. The company’s new scale conversion tool will help minimize any risk that large-scale processes performed in BIOSTAT STR single-use bioreactors do not generate the required critical quality attributes. The BIOSTAT STR family is a range of completely single-use bioreactors with a conventional stirred-tank design that is ideal for high-density cell culture applications. The range has

Integrated Applications Streamline Compliance Processes

3E Company, a leading provider of environmental health and safety compliance and information management services, announced a strategic alliance with Dotmatics, a leading provider of scientific informatics solutions and services to the life sciences industry. The alliance will offer Dotmatics and 3E customers access to a range of integrated applications designed to optimize scientific information management, chemical and formula risk analysis, environmental compliance, and workplace safety while helping to streamline processes, reduce costs, and increase efficiency. Having access to reliable and up-to-date scientific and regulatory information enables life sciences businesses to improve knowledge management, data storage, and decision support.

Meglumine Production Facility Opens in Spain

MilliporeSigma announced the opening of a facility in Mollet des Vallès, Spain, dedicated to the manufacture of meglumine, an FDA-approved excipient for pharmaceuticals and a component of medical imaging contrast media. The facility is the only location in Europe that manufactures meglumine, an amino sugar derived from glucose. The facility in Spain is solely dedicated to the production of meglumine, thereby ensuring continuity of supply to customers as well as meeting increasing demand for the excipient. As an excipient, meglumine interacts directly with active pharmaceutical ingredients to increase solubility. Therefore, the manufacture of meglumine must meet the same stringent regulatory and quality requirements as APIs.

www.labbusinessmag.com

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Suzuki MATTERS

By David Suzuki

We can learn so much

from Nature

I

Dr. David Suzuki is a scientist, broadcaster, author, and co-founder of the David Suzuki Foundation.

Learn more at www. davidsuzuki.org.

8

f you fly over a forest and look down, you’ll see every green tree and plant reaching to the heavens to absorb the ultimate energy source: sunlight. What a contrast when you look down on a city or town with its naked roofs, asphalt roads and concrete sidewalks, all ignoring the sun’s beneficence! Research shows we might benefit by thinking more like a forest.

Solar roads could be a step in that direction.

Roads, sidewalks and parking lots cover massive areas. Using them to generate power means less environmental disturbance, as no new land is needed to house solar power operations A French company, Colas, is working with the French National Institute for Solar Energy to test its Wattway technology under various conditions, with a goal of covering 1,000 kilometres of existing highway with thin, durable, skid-resistant crystalline silicon solar panel surfacing over the next four years. They estimate that could provide electricity for five million people. Although critics have raised questions about cost and feasibility, it’s not pie-in-the-sky. The technology is being tested and employed throughout the world.

Rooftops are another place to generate power using existing infrastructure. Elon Musk’s company Tesla is making shingles that double as solar panels. Although they cost more than conventional asphalt shingles, they’re comparable in price to higher-end roof tiles, and can save money when you factor in the power they generate.

These developing technologies show that, as the world continues to warm, we can and must move beyond our outdated ways. In Canada and elsewhere, the political approach to climate change has often been to avoid discussing it — in part by firing government scientists or vetting their public statements — and maintaining the status quo by

January/February 2017 Lab Business

lavishly supporting unproven and risky technologies like carbon capture and storage that keep us tied to fossil fuels for years to come. It’s nonsensical to dig up and melt oilsands bitumen, transport and burn it, and attempt to capture the emissions and stick them back in the ground, where nature had already stored the carbon.

Nature took millions of years to do it, but we aren’t a patient animal.

U.S. science writer Janine Benyus coined the term “biomimicry” to describe technologies based on nature’s ability to solve problems or exploit opportunities. It’s an important concept because it requires humility and respect for natural processes rather than the imposition of our crude but powerful technological innovations.

Every species shares the same challenges: how to get energy and food, avoid predators and disease (even bacteria get viral infections), what to do with waste and how to reproduce. Over long periods, numerous strategies to solve these challenges have evolved. We are a species magnificently adapted for survival, with a massive brain relative to our body size. Unlike any other species, we have the ability to ask questions and seek answers. We can find a treasure trove of solutions in the ways other species have dealt with challenges.

Biomimicry has inspired applications ranging from producing energy through artificial photosynthesis to building lightweight support structures based on the properties of bamboo.

By learning how nature works and how to work within it, we can overcome many problems we’ve created by trying to jam our technologies on top of natural systems. Fossil fuels were formed when plants absorbed and converted sunlight through photosynthesis hundreds of millions of years ago, then retained that energy when they died, decayed and became compacted and buried deep in the Earth, along with the animals that ate them.

Rapidly burning limited supplies of them is absurd, especially when they can be useful for so many other known and possibly yet undiscovered purposes.

Surely, with our knowledge and wisdom we can do better than rely on the primitive idea of burning things to stay warm and comfortable without regard for the consequences — pollution of air, water and land with its related impacts on health, as well as climate change, which is putting humanity’s survival at risk.

Our economic systems don’t often encourage the most efficient and least harmful ways of providing necessities. They aim for the quickest, easiest, cheapest and most economically profitable paths. We can do better than that. Harnessing the sun’s power and learning how nature solves challenges are good places to start. LB

Celebrating In 1971, Doug Brock recognized the need for manufactured high purity solvents. He started Caledon Labs with just a few products, and the goal of becoming a leader in the laboratory chemical industry.

Facility: We have grown from an 800 square foot building to a 20,000 square foot manufacturing facility.

Products: We now provide a wide selection of chemicals, as well as offering custom manufacturing capabilities.

People: Our most valuable asset many employees have been with us for over 25 years.

Quality: A superior standard of quality that our customers have come to expect.

At Caledon, we have built our success on our basic values of Trust, Quality, Service and Delivery. We invite you to experience the Caledon Difference, and allow us to be part of your success story.

Trust. Quality. Service. Delivery.

Caledon Laboratories 40 Armstrong Avenue Georgetown, ON L7G 4R9 Canada T 877.225.3366 E service@caledonlabs.com

Lab PROFILE

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January/February 2017 Lab Business

Lab PROFILE

A Passion for

Stem Cell Research Sanofi Biogenius finalist Miranda Li turns a passion into results at Nagy Lab story by

Hermione Wilson

M

iranda Li is not your typical 17-year-old. She holds a black belt in taekwondo, swims competitively and has a passion for stem cell research. In 2015, that passion led her to the Nagy Lab at the Lunenfeld-Tanenbaum Research Institute in Toronto, where she worked on an innovative project about characterizing suicide genes.

The Mentorship

It began with the Sanofi Biogenius Canada (SBC) competition, in which Li wanted to participate. The competition, which began in Toronto in 1992, is open to all students registered in high school. “The goal is to highlight excellent youth science research that’s going on in the field of biotechnology,” says Brent Peltola, Executive Director of Partners in Research Canada, which has been a managing partner of the SBC competition since 2013.

SBC starts with nine regional competitions where all the candidates do a poster presentation and oral presentation to a panel of judges who are drawn from industry and research in the field of biotechnology. Of the top five winners awarded at the regional level and each of the first place winners attends the national competition. A key component of entering the competition is securing a mentorship at a local laboratory, Peltola says. Most students do this before they send in their applications for the competition.

With that in mind, when Li had the opportunity to attend the prestigious Gairdner Awards (often a precursor to the Nobel Prize) in 2015, she made sure to introduce herself to Kristina Nagy, a research associate at the Nagy Lab and the wife of the lab’s principal investigator Dr. Andras Nagy. Li knew that the Nagy Lab performs work in stem cells, an area which was of particular interest to her.

“She had been reading up on what our lab had been doing,” Nagy says of that first meeting. “I was very impressed by her… having such initiative.” Nagy agreed to take Li on at the lab and the then 16-year-old started working at the end of October 2015.

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Lab PROFILE

Miranda Li at work on her suicide gene project at the Nagy Lab in 2015. Photos courtesy of Nagy Lab, Lunenfeld-Tanenbaum Research Institute.

The Project

Nagy Lab’s main focus is stem cells and their applications to regenerative medicine. “We are trying to figure out ways to use stem cells to transplant them into patients that are suffering from diseases that are currently not possible to really cure,” Nagy says. The project Nagy designed for Li would require the high school student to develop a tool that could assess whether different drugs caused stem cells that have been transplanted into patients to proliferate or not. “[When] you transplant cells into the individual... there’s always a risk that

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January/February 2017 Lab Business

those cells are going to become malignant, meaning they’re going to give you cancer, and the last thing you want is to cure a disease and give a patient cancer,” Nagy says. A way to solve that problem, she says, is to introduce a system into the cells before they are put into the patient whereby, if a certain drug which is not harmful to the patient by to which the cells are sensitive is introduced into the patient’s system, it will kill those cells. This system is known as a suicide gene system.

Depending on the application, some suicide gene systems are more effective than others, Nagy says. The most com-

The project Nagy designed for Li would require the high school student to develop a tool that could assess whether different drugs caused stem cells that have been transplanted into patients to proliferate or not.

monly used suicide gene system only kills cells that are proliferating, but there is a new system which Nagy says also kills cells that are not proliferating. Li’s task was to figure out what this was and at what stage in the cell cycle the drug was killing them.

The tool Li came up with to track the cells and their reaction to the suicide gene prodrug involved fluorescent proteins. The proteins can be produced by a cell and will light up with different colours under UV light. Using what Li calls the FUCCI (Fluoresence Ubiquitin Cell Cycle Indicator) System, a method of visualizing cell cycle

Lab PROFILE

behaviour that involves transecting extracts from corals and plants into the cells, the high school student was able to track cells as they progressed through the cell cycle and then observe how they reacted when she added the prodrug that triggered the suicide genes. “A cell that is in one stage of the cell cycle will be green, and as it goes into other stage of the cell cycle and starts to proliferate, it turns red,� Nagy explains.

This imaging technique allowed Li to see whether there were more green cells or more red cells dividing, or if each progressed at the same rate before and after the prodrug was added to the cells.

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Lab PROFILE “That information is very important to us in the long run because now we know how that suicide gene really works,” Nagy says.

Lab Work

During the eight months Li spent working at Nagy Lab, she got a crash course in research science at a very high level. Her typical day at the lab began after a day of classes and a 40-minute walk from her high school to the LunenfeldTanenbaum Research Institute, located near Toronto’s Mount Sinai Hospital.

“Depending on what stage of the project I was in, I would either work for half an hour and then go home and do homework, or there were days where I’d be at the lab until nine at night,” Li says.

With Nagy guiding her every step of the way, Li did a lot of molecular cloning, imaging and cell culture. She put together the cells she worked with, cloning together colour changing genes and suicide genes. “[Miranda] did a lot of cloning and she used plasma DNA in bacteria to amplify that,” Nagy says. “She did PCR reactions, she had to go and send bits and pieces of DNA for sequencing and check that the sequence was actually correct, the one we were expecting to get. Then she had to transect these cells, meaning putting the DNA into these cells, and culture those cells.”

Once the cell culture grew to larger quantities, Li had to split them into several dishes, freezing some to cryopreserve them, until she had to warm them up again. She also did a lot of imaging. The high school student was able to use one of the Lunenfeld Tanenbaum Research Institute’s most expensive and sophisticated microscopes, a two-photon laser-scanning confocal microscope valued at half a million dollars.

“That one’s really cool,” Li says. “That one had a special room that was downstairs and you needed a pass to get in and everything. With light microscope you can’t really tell the different colours, but with the confocal [microscope] we use different filters like fluorescent filters, so you could tell which cells were dividing.”

Analyzing the resulting images was another skill set Li had to develop, as well as understanding the complex soft-

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January/February 2017 Lab Business

Miranda Li gives a presentation at the Sanofi Biogenius Canada National Competition in Ottawa.

Photo credit: Katia Pershin Photography ware used to do that analysis.

“It was a steep learning curve for her, for sure, but she turned out to be very talented,” Nagy says. Li spent the first few weeks of her placement reading up on the work she would have to do, but Nagy says she caught on faster than some undergraduate and postgraduate students she works with.

It was by no means smooth sailing, however. Li says she experienced firsthand just how difficult research science is. “Whenever you read about something that a scientist did you think, ‘OK, that sounds pretty straightforward,’” she says. “They had this hypothesis, they went through these steps and they got to the results.” She soon discovered things weren’t so straightforward. During the course of her project, Li says there were a lot of trials and failures, and she found herself rushing to finish in time for nationals, after she won first prize at the Toronto regional level in April 2016.

Although she didn’t place at the national SBC competition, Li’s experience at Nagy Lab has definitely left its mark. She is seriously considering a career in research science and says she

learned more in her eight months at the lab than she ever did in her four years of high school.

“Even though I was taking biology and chemistry at the same time in school, the information that you might learn from the lab is so much more than what you would learn from the textbook,” Li says.

After the SBC competition was over, Li returned to Nagy Lab in the summer of 2016, this time under the mentorship of Dr. Mohammad Massumi. “He has these cells that produce insulin, so it was a very different project but I used a lot of the same skills and techniques I picked up [working at the lab] during the school year,” Li says. “We were trying to make a cell line that could... produce an unlimited supply of insulin for diabetes [patients].”

Nagy says having Li as a student lab assistant was a wonderful experience, one she says the lab would consider repeating. “I think it is really important for scientists to… go out and be much more transparent and let people in as much as possible in the lab, especially young people.” LB

Application NOTE Today, most maufaturing plants need replacement parts quickly due to decreased on site parts inventory.

ONE-STOP REPAIRS Medical device manufacturers can speed repairs and reduce costs by working with single source for full gamut of machine repairs story by

Dick Puhl

www.labbusinessmag.com

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Application NOTE

F

rom engineering to fabrication, finishing and assembly, medical device manufacturing incorporates a range of advanced mechanical, hydraulic and electronic technologies into its processes. With many enterprises utilizing digital design and prototyping systems, automated fabrication, CNC finishing, and multi-axis, laser-based quality assurance systems, the demands for effective and timely repair or replacement of equipment are often critical.

Given the vast array of parts involved, the seemingly straightforward task of maintaining equipment often presents a logistical nightmare that involves farming out components to a variety of specialty repair shops with variable capabilities, quality, pricing, and turnaround time.

Fortunately, the repair services industry is responding by broadening its capabilities to provide more of a one-stop-shop service for medical device fabricators, often with facilities strategically located near major manufacturers or manufacturing regions.

Specialized Equipment Fabricators of medical devices incorporate manufacturing technologies that are common to many industries, ranging from aerospace to consumer electronics.

For example, companies that make surgical implants, orthotic devices and medical instruments often employ sophisticated CNC systems to maximize productivity and control.

Although CNC systems may be unique in some aspects, many platforms, such as the Siemens 840D include sub-systems and components that are similar or common to other industries such as digital drives and motors, connectivity to many types of tools through standard interfaces such as Ethernet, and easy integration to many different CAD/CAM systems.

In addition, medical device manufacturers utilize a variety of spindles, spindle motors, arbors and tools to automatically perform precise machining operations such as drilling and milling.

There is no shortage of mechanical or hydraulic components. High-purity hydraulic pumps, mixers, motors, cylinders, rotary actuators, pneumatic valves, servo valves and blowers are used to provide automated handling of liquids, degassing systems, liquid-end assemblies, and flow cells.

Finally, manufacturing systems often contain sophisticated electronic control elements, such as robotics, PLC controllers, environmental sensors, and HMI control panels

that are designed to display real-time status information and alarm monitoring while also recording critical productionrelated data for on-the-fly analysis of events, system troubleshooting and process improvement.

Given the variety and complexity of machine components, repair or replacement often involves sending specific components out to specialty repair shops. For example, a hydraulic component repair shop does not have the capability to also repair motors; a motor repair shop cannot replace power supplies, I/O, memory or communication cards in sophisticated PLC systems; and robotic equipment must usually be repaired at a dedicated facility.

However, where these services can converge are with larger international repair service companies. Due to their size and expertise in many industries from automotive to aerospace, they are equipped to offer an array of repair services under one roof.

This includes the repair or replacement of components, including major manufacturer brands for the mechanical (servo motors, gear boxes and gear reducers, brake assemblies, vacuum pumps and blowers, air/fluid pumps, ballscrews) to the hydraulic (pumps, motors, cylinders, rotary actuators, servo valves).

In addition, companies can handle sophisticated electronic components including, replacement of controller cards for power supply, I/O, communication and memory, as well as HMI control panels. For robotic elements, their extensive expertise is used in other industries such as in the automotive manufacturing industry.

Regardless of the type of part, it is important to look for a repair company that will conduct an initial evaluation to identify the probable cause of failure, and then repair and test the part according to the manufacturer’s specifications and test procedures.

Proximity of Repairs One repair service company that has specifically pursued a strategic model of expansion by opening new locations in close proximity to existing major plants, as well as geographic regions that attract and support locally based manufacturing, is K+S Services, Inc. It operates 12 facilities across the globe, including Canada, the U.S., Mexico, and Europe. More than just a storefront with a lone representative that coordinates with a larger office, these repair facilities are fully equipped and functioning shops with managers, technicians and spare parts at each location.

Fabricators of medical devices incorporate manufacturing technologies that are common to many industries, ranging from aerospace to consumer electronics.

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January/February 2017 Lab Business

Application NOTE

Although CNC systems may be unique in some aspects, many platforms, such as the Siemens 840D include sub-systems and components that are similar or common to other industries.

www.labbusinessmag.com

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Application NOTE

Fabricators of medical devices incorporate manufacturing technologies that are common to many industries, ranging from aerospace to consumer electronics.

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January/February 2017 Lab Business

Application NOTE

Proximity, after all, has many advantages for the manufacturer. First and foremost, having a repair service in close proximity means repairs can be completed faster and the maximum possible uptime maintained. Today, most manufacturing plants need replacement parts quickly due to decreased on-site spare parts inventory.

In the event of an emergency, turnaround time is practically negligible.

Cases exist where a part has been picked up in the morning, repaired, tested, and returned that same day.

If physical proximity in terms of location has its benefits, there is no relationship closer than having a repair service representative stationed within the plant itself.

Some repair service companies provide additional specialized programs like the Smart Total Asset Management Program (STAMP) where customers are assigned a full-time, on-site account manager to serve as a one-stop facilitator and manager of all repairable assets within a specific plant.

This level of service includes tracking all repairs, expediting when required, shipping or delivering to and from the nearby repair facility, maintaining database integrity, streamlining and stabilizing procedures, generating a wide variety of reports and keeping the customer informed throughout the process.

Proof of the success of this business model rests with the number of corporations ascribing to it such as DePuy, GE Healthcare, Stryker, and Siemens which are among the more than 800 manufacturers successfully serviced in this manner. LB

The repair services industry is responding to the needs of manufacturers by broadening its capabilities to provide more of a one-stop-shop service for medical device fabricators.

Dick Puhl has 30 years of experience in the industrial component repair industry.

Puhl has helped provide solutions for nearly every type of manufacturing plant over the years with a major emphasis on Automotive, Aerospace, Tire, and Food and Beverage industries. He is the Director for K+S Services, headquartered in Southgate, MI, with offices in Canada, the U.S. and Mexico. Find more information at 800-542-1331; sales@k-and-s.com; or www.k-and-s.com.

If physical proximity in terms of location has its benefits, there is no relationship closer than having a repair service representative stationed within the plant itself.

www.labbusinessmag.com

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Lab WARE Versatility in Microscopy

The new Zeiss FPX flat panel extension for the ZEISS Xradia Versa 500-series of 3-D x-ray microscopes delivers large-sample, high-throughput scanning with “scout and zoom” imaging. Combined with the high resolution of the Xradia Versa X-ray microscopes (XRM), the new FPX enhances imaging flexibility and creates workflow efficiencies with an all-in-one system for industrial development and academic research. It scouts large samples two to five times faster to identify a region of interest.

The FPX extends the ability for the microscopes to achieve full field of view, wholesample imaging, up to five inches in diameter for samples 10 times greater in volume with higher throughput. www.zeiss.com

Integrating Flash Chromatography in Peptide Purification

New Immunoassay for Zika Virus now Available in Canada

Siemens Healthineers recently announced its CE-marked immunoassay, the Novagnost Zika Virus IgM µ-capture Assay, is now commercially available to laboratories outside of the U.S. The assay enables enhanced patient outcomes through differential diagnostics according to the WHO test algorithm. The assay is capable of detecting the Zika virus during the acute phase of infection, a few days after the onset of symptoms. Together with the recently announced real-time molecular VERSANT Zika RNA 1.0 Assay (kPCR), Siemens Healthineers is now offering laboratories Zika assays both for immunoassay and molecular detection. The Novagnost Zika Virus IgM µ-capture Assay is user-friendly, utilizing the same dilution and reagents as other Novagnost assays.

The assay is validated for use on plasma and serum. www.siemens.com/healthineers

The Novagnost Zika Virus IgM µ-capture Assay runs on the Siemens Healthineers BEP III and BEP 2000 systems.

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January/February 2017 Lab Business

High Resolution Imaging in Smaller Size

Headwall’s High Resolution Fluorescence Sensor is a spectral imaging sensor that collects chlorophyll fluorescence (CF) data vital to understanding plant and crop photosynthesis. The sensor collects image data across the CF emission spectrum from 670 to 780nm. This allows both the important ‘Oxygen-A’ and ‘Oxygen-B’ bands (O2-A and O2-B) to be used for more accurate insight into photosynthetic processes. The sensor uses an all-reflective approach and diffraction gratings. It is small and light enough for use aboard many commercial available UAVs, and it can also be used aboard aircraft and satellites. The sensor weighs about 6kg (13 lb.) and its footprint measures 300x200x200mm (12” x 8” x 8”). www.headwallphotonics.com

Biotage announced the launch of Biotage SNAP Bio C18 and Biotage SNAP Bio C4 cartridges, a new range of flash cartridges with wide pore media (300 Å) for reversed phase purification of peptides and other larger molecules.

The cartridges offer similar performance to the purification step (RP-HPLC), in a flash format.

They have an increased loading capability compared to prep RPHPLC, enabling more peptide to be processed in a single injection.

Biotage SNAP Bio columns are available in 10 g, 25 g, 50 g and 100 g-sized cartridges and contain silica for either cartridge.

Developed with a small particle size (20 µm) and large pore size (300 Å) they provide increased resolution and the effective separation of complex peptide mixtures, making flash chromatography an efficient technique for peptide purification. www.biotage.com

Lab WARE System Allows Economical Packing of Small Series of Products

MULTIVAC recently presented the compact R 081 thermoforming packaging machine for packing small series of medical and pharmaceutical products. It is ideal as an entry-level machine for small-scale production and companies which are planning to enter into automated packaging. The R 081 has a "slide-in" die change system for quick and easy format change, and it is possible to freely configure the formats. It is designed to run both rigid and flexible film and can be equipped with a variety of marking systems. The machine can also be equipped with evacuation and gas flushing systems to produce either vacuum packs or packs with modified atmosphere and reduced oxygen content. https://ca.multivac.com/en

Reducing Capture Bead Damage

Dolomite Bio has launched a new Injection Valve and Sample Loop for single cell RNA sequencing workflows. This option enables straightforward introduction of evenly distributed mRNA capture beads into the company’s RNA-Seq System for individual encapsulation of cells. The Injection Valve and Sample Loop is a complete module allowing barcoded mRNA capture beads in lysis buffer to be efficiently flowed through the RNA-Seq Chip without clustering or blockages. Mechanical stirring is unnecessary, and its four-way valve and compact microfluidic connections enable switching between the injection of the bead suspension and pumping of a driving fluid. www.dolomite-bio.com

Handheld Scanner Enables On-the-Move Sample Management

Ironless Linear Motors Provide Smooth motion and High Dynamic Velocity Range

PI is expanded its PIMag series of high dynamics linear motor stages.

The V-522 Voice-Coil Linear Stage has travel ranges of 5mm, 10mm, 20mm, and a maximum velocity of 250mm/s and has the frictionless voice-coil drive of the V-52x series. An integrated optical linear encoder and precision crossed roller bearings with anti-creep cage assist provide high positioning resolution and guiding accuracy. With very low moving mass and no moving cables, the voice-coil direct linear drive results in high scanning frequencies to tens of Hz. The stages can also be easily stacked to make XY systems. www.pi-usa.us

Ziath’s Handheld is a portable manual sample picking scanner.

It provides users with the ability to immediately identify tubes and track samples when away from the lab, with just one hand. This includes manual picking from repositories, as well as recording when collecting samples in the field.

Its applications include the generation of multiple pick lists for accurate tube selection, vial checking to confirm your sample is identified correctly, and the ability to easily record samples in the field at the point of collection. The scanner is battery-operated, and users have the option to enter data for specific samples as soon as they’re scanned. www.ziath.com

www.labbusinessmag.com

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Lab WARE 10-Minute Test Improves Moisture Analysis

Mettler Toledo offers SmartCal as a solution to the traditional time-consuming method. This test substance offers a fast way to verify the performance of a moisture analyzer. Using SmartCal, performance testing takes just 10 minutes and it is done in the same easy way as a regular moisture measurement.

SmartCal simultaneously tests both the heating and weighing units. When results lie within expected tolerances, it lends validity to all measurements made since the previous test. Results can either be stored directly in the instrument or manually entered into a free, validated Excel report. www.mt.com

Pipetting Robot Improves Flexibility and Efficiency

BrandTech Scientific’s new Liquid Handling Station (LHS) pipetting reduces repetitive manual pipetting and increases laboratory efficiency and reproducibility through automation. The LHS is an extremely compact benchtop instrument that has seven working positions and five available liquid ends in single channel volumes up to 1000µL and multichannel volumes up to 300µL. With a wide variety of accessories, this flexible system moves liquids between reservoirs, tubes and plates. It can be used for plate reformatting, ELISA and PCR setup, cherry picking, etc. www.brandtech.com

Accessory Enables Easier MDI Testing

Copley Scientific introduced the new Facemask Test Apparatus (FMA) to Next Generation Impactor (NGI) accessory for streamlined MDI testing. The new FMA to NGI accessory makes it easier to measure the aerodynamic particle size distribution (APSD) of MDIs with spacers and VHCs that utilize facemasks, using the NGI. Combining face models with the NGI induction port, the accessory allows infant, child or adult facemasks to be interfaced directly with the NGI under controlled conditions. www.copleyscientific.com

LIST OF ADVERTISERS & WEBSITES BioRad Page 2 .......... www.bio-rad.com/ddSEQsinglecell Canadian Food Business Page 4.............. www.canadianfoodbusiness.com Caledon Labs Page 9 ...................................www.caledonlabs.com Mottlab Page 22..........................................www.mottlab.com VWR Page 24 .................................................www.vwr.com

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Moments in time

Setting the Stage for

Gene Therapy

Photo: Frank L. Graham

I

n 1973, Torontonian Frank L. Graham and Alex J. van der Eb of The Netherlands co-developed a technique for introducing DNA into mammalian cells. They were originally working on an assay involving DEAE-dextran, one of the first chemical reagents used to transfer nucleic acids into cultured mammalian cells, that would allow them to analyze various fractions and fragments of infectious adenovirus DNA for its ability to infect and transform cells. They could not adapt the DEAE-dextran technique for their purposes. Instead, van der Eb suggested they look at the cellular uptake of labelled DNA as a measure of the efficiency of the assay. As a result, Graham and van der Eb were able to develop an assay for adenovirus infectivity. They also showed that “DNA fragments could transform and determined the size and location of the adenovirus transforming region, setting the stage for hundreds of subsequent studies involving DNA-mediated gene transfer,” as Graham wrote in 1988. LB

Sources 1973: Dr. Frank Graham co-develops a simple method of inserting extra copies of genes into mammalian cells.

His research represents a big step forward in the development of cancer gene therapy.” (CIHR) Frank L. Graham, recipient of the 1998 Robert L. Noble Prize (Canadian Cancer Society) Frank Graham is now a Professor Emeritus in McMaster University’s Biology Department. http://garfield.library.upenn.edu/classics1988/A1988Q713500001.pdf www.labbusinessmag.com

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ALL YOU NEED SOLUTIONS At VWR it is our mission to enable the advancement of science throughout the world. We do this by developing deep connections with our customers researchers like you who are on the verge of discovering new technologies, diagnosing and curing the world’s diseases, and designing applications to simplify our lives. We have a commitment to provide the best-in-class product portfolio, services, and operational efficiency to ensure that our customers can focus on their research.

All You Need Solutions are a testament to this mission. We now offer a comprehensive range of products and services suited to a specific industry or application. Whether you are working in the Life Science, Analytical, or Production environments we have programs designed for you.

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