16 minute read
ACROSS CANADA
Scc to launch
National Biotech Standards Committee
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Canadian subject matter experts who develop standards are unsung heroes. They may not wear capes and fight crime, but they help us be more productive, safe and healthy by lending their expertise to develop standards.
As an essential part of technology, innovation and trade, standards ensure products become more effective and efficient. Standardization provides an invisible infrastructure ensuring our cars start in the morning, our computers turn on, and our microwaves reheat our leftovers.
The same is true in biotechnology. Standardization in this industry ensures our water is safe to drink, our crops are fruitful, and our medicine works when we’re sick. On a national level, it also helps us make advancements, promotes innovation and facilitates international trade.
Recently, the International Organization for Standardization (ISO) member body for Germany submitted a new work item proposal for a developing field of technical activity on biotechnology. The proposal aims to launch a new technical committee on biotechnology standards to develop internationally recognized terms and conditions, analytical and diagnostic methods, computing tools and other useful resources. The idea is to reduce duplication while promoting collaboration between like-minded international organizations. Plus, subject matter experts around the world can participate in the process, share their knowledge and integrate the results of specific standards into their work. The aim is to build an effective international link between researchers, industry and regulatory organizations.
In response, the Standards Council of Canada (SCC), the Canadian member of the ISO responsible for ensuring a Canadian voice in international standardization, announced its intention to establish a Canadian committee on biotechnology. This Canadian committee will provide Canada’s position and views into the development of international standards. These Canadian committees are also known as mirror committees.
“We consulted Canadian subject matter experts in industry, government and consumer groups to see if there was interest in standardization in this promising new area of work,” says Sylvie C. Lafontaine, SCC’s vice-president, Standards and International Relations. “The response was very positive. Stakeholders are eager to commit to representing Canada by participating in the development of international standards
“We consulted Canadian subject matter experts in industry, government and consumer groups to see if there was interest in standardization in this promising new area of work. The response was very positive. Stakeholders are eager to commit to representing Canada by participating in the development of international standards for biotechnology.”
— Sylvie C. Lafontaine, SCC’s vice-president, Standards and International Relations
for biotechnology.” Through this process, Canada voted to approve the creation of a new international technical committee on biotechnology and to establish a Canadian mirror committee.
As Canada’s national standards body, SCC represents Canada on the two major international standardization bodies, the ISO and the International Electrotechnical Commission (IEC). SCC’s Canadian mirror committee related to the ISO’s biotechnology committee, will be working in consultation with biotechnology stakeholders in industry, government and academia, and will monitor the development of the international standard to vote for or against its acceptance based on Canada’s interest. The advancement of Canada’s economy, the facilitation of domestic and international trade, and the well-being of Canadians weigh heavily on these decisions.
With the Government of Canada’s release of the latest budget, the timing of this ISO biotechnology committee is excellent. The federal budget’s commitment to advancing biotechnology research and innovation showcases the government’s support of the biotechnology sector. Standardization will continue to increase in importance as the influx of funding takes effect and bolsters advancements.
While improving our competitive edge is a valuable benefit, the establishment of a Canadian committee on biotechnology also ensures Canada’s unique biotechnology research and industry landscapes are represented internationally and ultimately have a positive impact on the average Canadian.
In the field of biotechnology, compliance with standards is vitally important. “The establishment of ISO standards for biotechnology may be very useful in advancing health, safety and the welfare of workers and the public by emphasizing the need for both human and environmental safety and security throughout the development and commercialization of new products of biotechnology,” says Arash Shahsavarani, Unit Head, Regulatory Science and Policy Unit in the Biotechnology Section at Environment Canada. “Standardization in the production stage can mitigate potential risks to workers and ensure the quality of the end product.”
“Biotechnology is evolving rapidly,” says Lafontaine. “Given our growing population, changing environmental factors, and advancements in healthcare, standardization in biotechnology is critical to maintain functional, valid and sound innovation.”
Canada is certainly no stranger to advancements in biotechnology. “Canada is a world leader in some areas of biotechnology, in particular the area of nanocrystaline cellulose from wood pulp,” says Dr. Robert Crawhall from ICEage Digital Detection. “We already play an important role nanotechnology. Involvement in the biotechnology standards would strengthen our competitive advantage internationally.”
Standards that are developed internationally are becoming increasingly valuable. They complement uniform methods of production and reduce transit time and red tape. Establishing a Canadian mirror committee on biotechnology will help Canada continue to establish itself in the field and assist Canadian companies as they face competition on a global basis. By helping to shape the international standards landscape, Canada gains an important advantage.
This new committee supports other Government of Canada initiatives in this sector. Health Canada’s Canadian Biotechnology Strategy (CBS) complements the regulatory and research activities of various federal departments related to the emerging field of biotechnology. In line with the CBS, Canada’s participation in this new international technical committee will ensure that Canadian needs are voiced and positions are reflected to further “ensure that Canadians have access to, confidence in and benefit from safe and effective biotechnology-based products and services.” (CBS) This Canadian technical biotechnology committee would also showcase Canada as a responsible front-runner in the industry.
SCC is a federal Crown corporation that promotes efficient and effective standardization in Canada. SCC is Canada’s ISO representative and is responsible for coordinating Canadian participation in the development of international standards. It also accredits standards development and conformity assessment organizations.
For more information on how to participate in SCC’s Canadian mirror committee on biotechnology, please contact: Mick Lord, director of Standards Operations, at mlord@scc.ca.
To see this story online visit http://biotechnologyfocus.ca/ scc-to-launch-national-biotechstandards-committee/
Balances Sartorius announces the launch of its new Secura® laboratory balance designed for users who work in regulated environments and need high-quality results. The balance monitors its ambient conditions automatically, thereby preventing handling errors. Nine different models of the Secura balance are available, covering a range of weighing capacities from 120 grams to 5,100 grams, and a readability of 0.1 to 10 milligrams. The balance is also equipped with various assistance systems designed to prevent further processing of uncertain weighing results, which frequently occur through operating errors during weighing. If errors occur, the balance identifies the uncertain weighing results in the display and blocks their transmission. In addition, the balance’s calibration and adjustment function, isoCAL, informs the user and automatically adjusts the balance using internal weights. Every adjustment is documented and can be traced for quality assurance purposes. Web: www. sartorius.com
Sample Preparation The Metrohm
909 UV Digester is a digestion instrument for UV photolysis of water samples with low to medium organic loads. Intended for sample preparation in trace element determination by means of voltammetry, ion chromatography and spectroscopy (AAS, ICP), this instrument features an operating unit and wet end as well as air
cooling and automatic control of digestion temperature and time. It can take up to 12 samples with a maximum of 12 mL sample volume each. Web: http://metrohm.com
Mixers The new HyPerforma Single-Use Mixer (SUM) DS 300 system from Thermo Fisher Scientific Inc. is a single-use mixer ideal for pilot-scale liquid preparations for vaccine and biologic manufacturing. The system can be used for both upstream and downstream processing, and is designed for multiple uses including mixing buffers and media from liquid-to-liquid and power-to-liquid, as well as re-suspension applications. It has a docking station with an adjustable top-mounted, angled mixing system for either a single-use bioprocess container bag or liner in stainless steel or standard plastic drums that can accommodate volumes from 50 to 300L with a 5:1 turn down ratio. Web: www.thermofisher.com
Load Cells Omega introduces its new series of waterproof, low profile load cells for wet or washdown applications. The high accuracy LSHD has an all stainless steel construction for harsh industrial environment with one per cent interchange-
ability for scale applications. It features a three metre waterproof cable but longer lengths are available. Ideal for industries involving chemical, water petroleum and scales. Web: www.omega.ca
Bioreactors Pall Corporation launches its XRS 20 Bioreactor System. The new bioreactor incorporates a single-use Allegro™ 3D biocontainer and a touchscreen interface for easy monitoring and control of process parameters. It is designed for cultivation of mammalian cells in suspension culture and can also be used for applications ranging from general life sciences research to seed train operations and full Good Manufacturing Practice (GMP) production at the two-to-20 litre scale. Web: www.pall.com/bioreactors
Sensors Gems Sensors & Controls’ new CAP-100 Series Capacitive Liquid Level Sensors feature a non-contact/nonintrusive sensor that senses from outside non-metallic reservoirs or bottles with wall thicknesses up to 0.39” (10mm) thick
without attaching the bottle. The sensor supports aqueous or non-aqueous liquid detection, with a choice of Wet- or Dry-Sink switch actuation. The CAP-100 sensors are CE-approved and incorporate LED signal and power indicators with an integrated potentiometer that allows for sensitivity field adjustments. The compact sensors are ideally suited for vessels containing biohazardous liquids and medical applications such as waste, reagent, buffer or diluent as well as dark, sticky or viscous fluids. Web: www.gemssenors.com
Temperature Controllers Oven
Industries Inc. announces its new laboratory ramp and soak temperature controller. The enhanced 5R6-900 bench top unit is contained all in one enclosure and can be plugged into the wall as a self-contained temperature control system with its own power supply. The device can be used universally, which allows the user to use the device wherever they are located. As a solid state MOSFET bidirectional compact unit featuring an internal power supply, it is also capable of loading currents up to 10A and is user-friendly and PC programmable. Web: www.ovenind.com
Peristaltic pump Aalborg® Instruments TPU1 and TPU2 Pump Heads are designed to move liquids of low to high viscosity from source to destination at user-set speeds according to the motor installed. Each head is mounted on a front panel with an adjustable occlusion wall and safety cover. Installation is quick and
easy, simply attach the pump head to your motor using the existing mounting holes or modify them to fit your need. Web: http://www.aalborg.com/
Balances and Scales Mettler Toledo
PINMOUNT SWC515 weigh modules let you add weighing capabilities to your process by converting a tank or conveyor or other structure into a scale. They are designed for static and dynamic applications where loading involves horizontal forces. PINMOUNT is available in capacities of 7.5t, 15t, 22.5t, 30t, 50t and 100t. The incorporated load
cells host an on-board microprocessor to monitor internal and external influences that affect weighing accuracy. It compensates for temperature changes, vibrations, hysteresis and non-linearity, providing accurate results. Web: http://ca.mt.com/ca/en
Laser diode collimators Optoelec-
tronics Company has introduced a range of tiny laser diode collimators with high alignment accuracy specifically aimed at OEMs and system integrators using laser-based technology in their products. The laser diode collimators from the Optoelectronics Company measure only 6mm in diameter and 8mm in length and they come available in standard lasing wavelengths from 635nm to 852nm with standard output powers from 0.9mW to 75mW although customised versions can be manufactured to order. They have an elliptical output beam with a collimated diameter of only 2.5 x 2mm which is bore-sighted for greater precision. The output beam can be collimated or focused as necessary. Web: www.oe-company.com/
Evaporator The new KD Scientific Centrifan™ PE is a compact evaporator/ concentrator for research, pharmaceutical, and biotech labs working with samples such as DNA, RNA and protein. Its self-generated blowdown technology eliminates the potential problems with common evaporation systems such as vacuum centrifuges, rotary evaporators, nitrogen blow-down and freeze dryers. It also dries samples without the monitoring required by a rotorvap. In addition, the system works well for processing fractions collected from flash liquid chromatography. Web: www.kdscientific.com
Titrator The Mettler Toledo EasyPlus™ is a compact and simple titrator specifically designed for basic requirements and first time users of automatic titrators in the food and chemical industries. This new model focuses specifically on accurately automating routine titrations. Apart from the improved accuracy and reproducibility of results, the EasyDirectTM titration software stores and collates all records and archives data to minimize confusion, errors and misinterpretation of results. Start your routine analysis with a LongClick™ on the home screen. The intuitive navigation speaks 15 languages. iTitrate Intelligence makes method programming simple with EasySetup guidance. Set only the minimal parameters and the titrator programs the rest, including correct calculations based on desired measurement units. Web: www.mt.com/easyplustitration
Hot Plate The new EchoTherm™ Model HS61 Large Surface Programmable Stirring Hot Plate from Torrey Pines Scientific, Inc. comes equipped with precise temperature ramping for use in chemical, pharmaceutical, environmental, biochemical and other laboratories where reproducible, accurate, hands-off sample preparation and experimentation are a must. The unit stores 10 programs in its memory of as many as 10 steps. Each step is a temperature,
temperature ramp rate, stirring speed and time. Each program can be made to repeat itself automatically from one to 98 times or infinitely if desired. All programs are stored electronically. Temperature ramping rates are settable in 1ºC/Hour increments from 1ºC/Hour to 450ºC/Hour. The heater plate is a 12” x 12” solid ceramic for excellent chemical resistance and quick heating from ambient to 400°C. Accuracy is 1 per cent of the reading using platinum RTD circuitry. The units are supplied with temperature calibration certificates traceable to NIST and solution probe. Stirring speed is 100 to 1500 rpm and controlled by optical coupler to 10 rpm. Web: www.torreypinesscientific.com/
Particle Analyzer The Beckman
BioPhotometers The Eppendorf BioCoulter DelsaMax PRO light scattering and Photometer D30 is the third generation of zeta potential analyzer provides precise Eppendorf BioPhotometers. Measurement measurement of the size, structure and data with this device can be recorded for charge of particles 0.4 to 10,000 nm in fixed wavelengths, making it ideal for routine diameter in as little as one second. Its new card:Layout 1 1/31/2013 9:09 AM Page 1applications. The detection instrument portfolio of Eppendorf is supported by accessories and consumables, such as the UVette®, a UV-transparent disposable cuvette, and the new semi-micro and macro Vis Cuvettes. Additional accessories that include reference filter sets and a microvolume measurement cell, the µCuvette G1.0, to measure sample volumes of only 1.5µL, are available. Avalanche photodiode detector provides size measurements and 31 independent photodetectors measure zeta potential, dramatically reducing analysis time. Chemistry and material applications are facilitated in the PRO through fast, reliable measurement of sub-10 nm particles, weak scatters and dilute systems. Measuring zeta potential in particles down to 1 nm means that small biologicals can be analyzed and proteins in native conditions are not damaged. This allows stable and reproducible assessment of zeta potential and isoelectric point even at very low volumes and low concentrations. Web: www.eppendorf.com
SRC101
Web: www.delsamax.com/
Gas Chromatography The new
Tracera gas chromatograph from Shimadzu Scientific Instruments integrates a new barrier discharge ionization detector, making it possible to reveal trace components not easily detected by other devices. Capable of providing high-sensitivity analysis of organic compounds, permanent gases and light hydrocarbons, the device’s barrier discharge ionisation detector responds to all compounds except He and Ne.
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JUlY 2013
July 7-9
Biotechnology & Human Health Symposium Venue: Georgetown Royalty, PEI Tel: (902)367-4400. Email: jennifer@peibioalliance.com Web: http://biotechnologyandhumanhealth. com/
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Protein Society 27th Annual Symposium Venue: Boston, MA Tel: 301-634-7277 Fax: 301-634-7271 Email: cyablonski@proteinsociety.org Web: http://www.proteinsociety.org/ symposium/
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