Teknova has completed the United States Food and Drug Administration (FDA) notification process for its CDC formulation Viral Transport Medium (VTM). Teknova Viral Transport Medium is in compliance with the FDA’s COVID-19 Transport Media Policy, July 2020 guidelines. Teknova is now offering the validated Teknova Viral Transport Medium for commercial distribution.
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.
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“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. “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.”