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Teknova completes FDA notification for room temperature-stable viral transport medium

publication date: Jan 12, 2021
 | 
author/source: Teknova

teknova-completes-fda-notification-room


Eliminating the need for refrigeration of samples will boost coronavirus testing worldwide

Teknova, a leading manufacturer of cell culture media and supplements, purification buffers, and molecular biology reagents, has completed the process of FDA notification for its Active Viral Transport Medium (ATM). ATM is a room temperature-stable version of Teknova’s CDC formulation Viral Transport Medium (VTM)and is manufactured under GMP conditions in compliance with ISO 13485 standards.

The requirement for refrigerated storage and transport of nasopharyngeal samples for viral testing poses significant logistical and financial challenges that have increased dramatically with mass COVID-19 testing. Teknova’s proven track record of rapid product development and expertise in media formulation make the company ideally placed to face these challenges head-on.

On the subject, Teknova CEO Stephen Gunstream said, “After the successful rollout of our VTM, we were looking for new ways in which Teknova could help in the fight against COVID-19. We realized that developing a transport medium that eliminates the need for refrigeration of samples during storage and transport would allow healthcare systems worldwide greater access to COVID-19 testing.”

After sample collection, ATM maintains viral stability at room temperature for up to 72 hours and can also be stored at room temperature prior to use. ATM is tested for pH (USP <791>), conductivity (USP <644>) and sterility, and additional quality control is applied in the form of bioburden testing (USP <61>). Using bovine serum albumin for ATM instead of fetal bovine serum (FBS) provides better lot-to-lot consistency and eliminates the risk of RNA degradation by RNases present in FBS, giving users and clinicians greater confidence in their test results.

 

Learn more about ATM

 

About Teknova

Founded in 1996, Teknova has established itself as a leader in providing critical reagents for bioprocessing, bioproduction, and molecular diagnostics. Product offerings include cell culture media and supplements, protein purification buffers, and molecular biology reagents for the life sciences and healthcare communities. Teknova prides itself on its agility and customer centricity, allowing the company to meet the most complex formulation and packaging requirements at unprecedented delivery times. Teknova supports customers in the research, clinical, and applied markets with custom and specialty products beyond standard catalog offerings, delivering cost savings for research and development, diagnostics, and production of therapeutics.

 


 



 

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