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.
Like many businesses, LaunchWorks was thrown for a loop when the COVID-19 pandemic hit, but not in the same way as some other manufacturers. The company was already on a strong growth trajectory for 2020, but when shelter-in-place mandates were announced, access to doctors’ offices limited the activity of most of the existing customer base. The company was able to harness its strengths to quickly pivot by promoting and expanding COVID-19 test kit manufacturing capabilities. As a result, LaunchWorks anticipates tripling its size this year. Automation is a key factor in scaling up to serve clients.
Expanding that quickly to help meet the country’s public health needs is not a simple task. The company focused on a combination of long-term industry supplier relationships, innovative thinking and automation solutions. LaunchWorks already utilized automation, but adding new functionality and additional capacity for the COVID-19 efforts helped move from producing 75,000 transport media tubes a week to an anticipated 1 million per week. (more…)
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New name reflects ongoing commitment to supporting the life science community by LaunchWorks.
LaunchWorks Manufacturing Lab, a company serving the life science market, is now LaunchWorks CDMO (Contract Development and Manufacturing Organization). Launchworks recently received their ISO 13485 as a CDMO. Accompanying this new capability, the company has revamped its website and reimagined a logo design consistent with other divisions of its parent company Integreon Global.