The FDA has added the CDMO to its list of approved vendors
LaunchWorks CDMO 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 media is available in the form of bulk tubes, large volume containers and a specimen kit, which will include a tube of sterile 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 LaunchWorks’ expansion in molecular diagnostics.
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 its latest addition.
“We’re grateful to contribute to the fight against the pandemic, and to add this important component to our product portfolio,” said 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.”