Teknova’s validated and CDC formulated Viral Transport Medium (VTM) is now FDA compliant and available for distribution.

The company currently has the capacity to manufacture 50,000 tubes of VTM a day and is on track to produce more than 3 times that number of tubes daily over the coming months.

Throughout the manufacturing scale-up, Teknova has continued to put quality at the forefront. Teknova manufactures VTM and saline for sample transport under GMP conditions in compliance with ISO 13485 standards and the Quality System Regulations under 21 CFR Part 820. The company also performs additional bioburden testing to ensure product sterility.

“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 Stephen Gunstream, Teknova’s CEO.

Gunstream continued: “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.”

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