Virus transport medium completes FDA notification process
Teknova, a manufacturer of cell culture media, protein purification buffers, and molecular biology reagents, has completed the US Food and Drug Administration (FDA) notification process for its CDC formulation Viral Transport Medium (VTM).
The Teknova VTM is now in compliance with the FDA’s COVID-19 Transport Media Policy, July 2020 guidelines, and the company is offering the validated VTM for commercial distribution.
As the SARS-CoV-2 pandemic took hold, and with a sudden and ongoing need for millions of coronavirus tests, there was a significantly increased requirement for approved media to maintain virus viability from sample collection to the laboratory. Teknova responded immediately to this need, and within six months has set up and upscaled manufacturing for a new product, and also completed FDA notification for the product. The company currently has the capacity to manufacture 50,000 tubes of VTM a day, and is on track to produce more than three times that number of tubes daily over the coming months.
“We are excited to have been able to go from zero production to FDA notification within six months and further contribute to combating COVID-19,” said Teknova CEO Stephen Gunstream,. “In March of this year, we had no idea we would be making viral transport medium; we hadn’t even thought about it. It has been an incredible effort to configure our manufacturing space; engineer, build and install equipment; set up automation; and implement the formulation and quality control processes necessary to deliver this formulation of viral transport medium. We are pleased to be able to contribute to curbing this pandemic and returning our world to some form of normalcy.”