Issue link: https://www.e-digitaleditions.com/i/1300450
www.biopharminternational.com October 2020 BioPharm International eBook 9 GMPs Guide COVID-19 Vaccine Manufacturing Recent industry guidance aims to anchor rapid COVID-19 vaccine development in good manufacturing practice protocols. M ajor bio/pharmaceutical companies and contract service providers lead- ing the charge to bring COVID-19 vaccines to market are familiar with established good manufacturing prac- tices (GMPs). To support manufacturers in the rush to develop a vaccine, FDA, in June 2020, released indus- try guidance (1) highlighting the development and licensure of COVID-19 vaccines. For example, FDA noted in the guidance that no "accepted surrogate endpoints" to which clinical test- ing can aim currently exist. Without these target end- points, there is likely no ability to form a reasonable prediction that a potential COVID-19 vaccine would demonstrate a clinical benefit. FDA has recommended that any vaccine development program should, there- fore, follow a traditional route to approval, meaning the development programs should demonstrate the vaccine candidate's safety and efficacy in protecting patients from infection by the SARS-CoV-2 virus and/ or clinical disease that results from infection. "The FDA Guidance highlights the pertinent CGMP [current good manufacturing practice] considerations for all vaccine manufacturing and serves as a reminder of statutory GMP expectations for COVID-19 vaccines specifically," says Karolyn Gale, senior director, regula- tory affairs, Emergent BioSolutions, a contract develop- ment and manufacturing organization (CDMO). The CDMO was granted a $628-million task order under an existing contract with the Biomedical Advanced Racamani - Stock.adobe.com FELIZA MIRASOL Regulatory Sourcebook Regulatory Guidance