The company’s facility received manufacturing authorization for clinical trial materials under good manufacturing practice (GMP) from the European Medicines Agency (EMA).
As suggested by its name, the suite becomes the third approved, with all three suites located at CureVac’s corporate headquarter campus in Tübingen, Germany.
In addition, a fourth production suite is currently under construction at the same site, after the company secured funding from the Bill and Melissa Gates Foundation to develop mRNA vaccines against specific targets.
The facilities will produce materials for the company and its partner’s clinical trials into mRNA-based therapies, as well as having capacity for early launch supply.
Its most recently approved suite has a ‘flex design’, meaning that it can produce batch sizes at full scale or at smaller capacities.
“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 CEO.
In a previous interview with in-PharmaTechnologist, Menichella told us that the company believes its mRNA technology can replace existing vaccine manufacture due to its speed and the resulting lower cost of production.