Oragenics and contract development and manufacturing organization (CDMO) Avid Bioservices have entered a process development and drug substance manufacturing agreement for Oragenics’ novel SARS CoV-2 (COVID-19) spike protein vaccine candidate, Terra CoV-2, with the aim of advancing to human clinical trials by early 2021, the companies announced in an August 20, 2020 press release. Avid will supply analytical method development, process development, and drug substance manufacturing services.

The first phase of the project, including analytical method feasibility and qualification activities, will start immediately. The next stage will be upstream and downstream process development and CGMP drug substance manufacturing of Terra CoV-2 in Avid’s Myford facility, which is located next to the company’s headquarters in Orange County, CA.

“Avid specializes in recombinant protein production, a critical component in the development and potential commercialization of our lead coronavirus vaccine candidate, Terra CoV-2,” said Alan Joslyn, president and CEO of Oragenics, in the press release. “With Avid’s existing manufacturing infrastructure, which includes three 2000-L single-use bioreactors and considerable space for expansion, they are the right manufacturing partner to scale-up to the significant levels of bulk vaccine substance that would be required to combat COVID-19, should our vaccine be approved by regulatory authorities.”

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CDMO Avid Bioservices will provide development and drug substance manufacturing for Oragenics’ novel COVID-19 vaccine candidate, Terra CoV-2. 