LaunchWorks and Canadienzyme, a biotech spin-off company by two McGill University scientists, announced their collaboration to produce a new RT-qPCR Master Mix.
Canadienzyme stepped in to help Canada’s national efforts due to a shortage of tests amid the Coronavirus pandemic. In doing so, they created a made-in-Canada RT-qPCR testing reagent that works as well as international versions on patient samples. This new Master Mix provides a domestic supply in Canada and increases available inventory in the U.S.
“Prior to COVID-19, there were no made-in-Canada RT-PCR testing solutions. Seeing the need; we stepped in to make these tests domestically so Canadians could be tested reliably on a broad scale,” said Dr. Martin Schmeing, CEO of Canadienzyme. “These tests are designed not just for the current pandemic, but will also equip Canada to respond quickly to other future challenges to the health of Canadians. We anticipate that the Master Mix can be applied for use in most, if not all, clinical diagnostic PCR testing applications.”
“By leveraging our commercial expertise with Canadienzyme’s scientific innovation, we were able to launch the Master Mix in record speed and increase access to a much-needed product,” says Celine Barakat, General Manager of LaunchWorks. “By collaborating directly with inventors and scientists, we’ve proven that we can bring innovative life science solutions to market quickly and efficiently.”
The new RT-qPCR Master Mix developed by Canadienzyme is now available through LaunchWorks in the US and Canada. The two companies will continue to work together to explore other diagnostic products and to bolster Canadian innovation and manufacturing in life sciences.
LaunchWorks has increased its filling capacity for the production of diagnostic test kits with the addition of new automation equipment at its Beverly, MA and Anjou, Canada facilities.
The expansion is part of LaunchWorks response to help meet the world’s public health needs in disease diagnosis and the fight against COVID-19. With the addition of the new filling automation equipment, LaunchWorks has the functionality and capacity to produce up to 500,000 microtubes or transport media tubes per week. The new automation also improves the quality process by increasing the reproducibility of vial filling.
“Our new suite of filling and capping machines will be easily redeployed for different formulations, allowing us to reduce the cost of manufacturing for customers,” says Celine Barakat, General Manager of LaunchWorks. “This increased capacity reinforces our commitment to support the world’s changing needs during the pandemic, and, beyond that, the growing molecular diagnostics market.”
Originally formed within Enzymatics in 2009 and now in two locations (Beverly, MA and Anjou, Canada), LaunchWorks has evolved over the past 12 years to become an ISO 13485 certified company that is FDA Registered. Integreon Global acquired LaunchWorks in 2017, and has since worked to add new service offerings, including embarking on a filing automation program designed to help its customers be more competitive. A significant portion of the company’s recent efforts has revolved around the response to the COVID-19 crisis.
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LaunchWorks today announced the opening of a new facility in the Montreal borough of Anjou to support the company’s continued growth and support in providing products to fight COVID-19. The new facility is registered with the FDA and received a Medical Device Establishment License (“MDEL”) from Health Canada.
The MDEL is a license issued to companies for the activities of manufacturing, importing and distributing (selling) of class I medical devices for human use in Canada. LaunchWorks Canada is operating with ISO 13485 compliance to achieve certification this year.
“We are very excited about our new facility and obtaining our MDEL and FDA registration. This is a key milestone in our plan to expand our products and services to the U.S. and Canada,” says Celine Barakat, General Manager of LaunchWorks. “And we look forward to applying our extensive manufacturing and service expertise to assist the Canadian molecular diagnostic market.”
“This new MDEL licensed facility reinforces our commitment to continue to expand and support the needs of the diagnostic industry in Canada and beyond,” added CEO of Integreon Global, Maurice Barakat. “Along with our investments in automation and device manufacturing the LaunchWorks service suite is uniquely positioned to meet the challenge of helping companies translate their science into commercial products.”
Originally formed within Enzymatics in 2009 in Beverly, MA, LaunchWorks has evolved over the past 12 years to become an ISO 13485 certified company that is FDA Registered. Integreon Global acquired LaunchWorks in 2017, and has since worked to add new service offerings, including a filling automation program designed to help its customers be more competitive. A significant portion of the company’s recent efforts has revolved around the response to the COVID-19 crisis.
The Anjou location will provide LaunchWorks with both increased capacity and strategic alignment with the LaunchWorks business continuity strategy. The LaunchWorks Anjou location is co-located with sister company, Cryopak, a leader in temperature control packaging and monitoring solutions.
LaunchworksCDMO added to FDA list of approved vendors for validating and distributing VTM, in accordance with COVID-19 EUA Transport Media Policy
LaunchWorksCDMO, a contract development and manufacturing company serving the life science market, has been approved to manufacture and distribute Viral Transport Media, in accordance with Section IV.B of the FDA’s COVID-19 Transport Media Policy.. The company’s Viral Transport Media is available in the form bulk tubes, large volume containers and a specimen kit, which will include a tube of sterile LaunchWorks VTM, a biohazard bag and an absorbent bag. Additional options include Nylon-flocked NP swab, Barcode or QP-coded labels, patient card, and a UN 3373 return box.
The Viral Transport Media is a new addition to the LaunchWorks suite of products and service offerings. As an FDA-registered ISO 13485 certified company, LaunchWorks is a division of Integreon Global, which has supported LaunchWorks’ expansion in molecular diagnostics with the additions of new service offerings, including embarking on an automation program designed to help its customers be more competitive. Recently, a significant portion of the company’s efforts have involved the response to the COVID-19 crisis, and the development of Viral Transfer Media is a valuable addition.
“We’re grateful to contribute to the fight against the pandemic, and to add this important component to our product portfolio,” says Jeff Kelly, General Manager of LaunchWorks CDMO. “Our team has worked hard to bring this product to market, and the addition brings us one step closer to offering an end-to-end solution for our customers supporting the fight against COVID-19.
”This reinforces the LaunchWorks’ commitment to continue to expand and support the world’s changing needs due to the pandemic, he continued. “The Launchworks service suite ranges from package design to formulation, filling and fulfillment, making us uniquely positioned to help companies translate their science into commercial products. We take pride in our ability to contribute to the resulting improvement in world health.”
LaunchWorks VTM and other COVID-19 information can be viewed here.
LaunchWorks is a winning team of innovative, experienced, and knowledgeable contract manufacturing experts with a track record of turning complex life science ideas into high-quality products on-time and on-budget. They are committed to accelerating life science product commercialization by optimizing every step of the manufacturing process in order to create high-quality products for our customers that reach the market and the people that need it, safely and quickly. For more information visit www.launchworkscdmo.com
About Integreon Global
Founded in 1990, Integreon is a complete packaging solutions provider dedicated to providing goods and services to maintain the integrity of our clients’ products. Our team includes a full complement of engineers, designers, and manufacturing specialists with the collective skills, gathered in one close-knit organization, to assure easy access to leading experts. For more information visit www.integreonglobal.com
LexaGene Holdings Inc announced another milestone in its journey to commercially launch flagship analyzer product MiQLab before the end of September – the hiring of LaunchWorks as its contract manufacturer.
LaunchWorks is an FDA registered, ISO 13485 certified, cGMP compliant group specializing in manufacturing consumables for life science firms, LexaGene said.
It will manufacture the assay panels and buffer sets used in LexaGene’s fully automated MiQLab system.
“LaunchWorks can currently manufacture enough products to easily support our commercial launch and have the facilities to scale their production to meet any demands that we require. I am very impressed by their facilities, high caliber staff, and their ability to scale their operations to meet our needs as we grow,” Dr Jack Regan, LexaGene’s CEO and founder, told investors in a statement.
MiQLab is a fully automated genetic analyzer designed to deliver reference-quality data at the point-of-need and can return results in about one hour. LexaGene says the technology can be used in multiple billion-dollar markets, including human and veterinary diagnostics as well as food safety testing.
“This is an extremely exciting time for LexaGene. Our initial hires in sales are working out exceedingly well and we are in the home stretch for manufacturing and qualification. By the end of next month, we expect to begin selling and fulfilling delivery of our first units, which will be a huge milestone for the company,” added Daryl Rebeck, LexaGene’s president and co-founder.