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Approval covers manufacturing and distribution in accordance with Covid-19 transport policy
LaunchWorks, a contract development and manufacturing organization (CDMO) serving the life sciences market, has been approved to manufacture and distribute viral transport media (VTM), in accordance with Section IV.B of the FDA’s Covid-19 transport media policy.
The VTM, a new addition to the company’s products and services, is available in the form of 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.
As an FDA-registered ISO 13485 certified company, LaunchWorks is a division of Integreon Global, which has supported the CDMO’s expansion in molecular diagnostics with the additions of new service offerings, including embarking on an automation program. Recently, a significant portion of the company’s efforts have involved the response to the Covid-19 crisis, and the development of VTM.
Integreon Global includes four companies: LaunchWorks, Cryopak, DDL and NexKemia. Each company offers unique critical supply chain components, including cold chain temperature monitoring options, packaging, product and materials testing, contract manufacturing and EPS resin manufacturing.
The LaunchWorks service suite ranges from package design to formulation, filling and fulfillment.