CureVac AG has received manufacturing authorization for clinical trial materials produced under Good Manufacturing Practice (GMP) from the competent national authority, Regierungspräsidium Tübingen (as representative of the European Medicines Agency (EMA)), for the company’s scaled up GMP III production suite. This license marks CureVac’s third production suite to manufacture at the highest standard of pharmaceutical production in the world. CureVac’s GMP I, II and III production suites are located at CureVac’s corporate headquarters campus in Tübingen, Germany.
The scaled up GMP III production suite is based on a newly developed GMP-manufacturing process and is designed to work in concert with CureVac’s GMP IV production suite, which is currently under construction. The GMP III production suite will meet mRNA demand for CureVac’s proprietary and partnered Phase I, II, and III clinical trials and early launch supply. Depending upon a trial’s mRNA demand requirement, the GMP III production suite is a flex design geared to produce mRNA batch sizes at full-scale capacity or at various smaller capacities. CureVac’s existing GMP I and II production suites—GMP certified in 2006 and 2010, respectively—remain focused on CureVac’s proprietary and partnered program preclinical and early Phase I clinical mRNA production.
“The ability to produce mRNA to specification, in scaled up batches, is equally as critical to the science behind mRNA’s therapeutic and prophylactic vaccine revolution,” said Dan Menichella, CureVac’s chief executive officer. “It is testament to the expertise and consistency of our production, engineering, quality control and assurance teams that our GMP III production suite has now received the manufacturer´s authorization. CureVac can continue to confidently serve the growing need for mRNA to fill the demand from our expanding pipeline of proprietary and partnered clinical mRNA programs.”