- Clover Biopharmaceuticals said its contract development and manufacturing organization (CDMO) received a European Union Good Manufacturing Practice (EU GMP) certificate for producing the company's lead COVID-19 vaccine candidate, SCB-2019 (CpG 1018/Alum).
- Clover created the COVID vaccine by combining SCB-2019 with Dynavax's ( NASDAQ: DVAX ) CpG 1018 advanced adjuvant and aluminum hydroxide (alum).
- The EU GMP certificate is in connection with Clover's regulatory filing to the European Medicines Agency (EMA) and follows a successful inspection of the CDMO site by the Ireland Health Products Regulatory Authority, the company said in a Sept. 20 press release.
- DVAX +3.01% to 10.95 premarket Sept. 20
For further details see:
Clover, Dynavax COVID-19 vaccine gets EU GMP certificate