Exothera, a CDMO specialised in viral vectors for vaccines and gene therapies, has received Good Manufacturing Practices (GMP) certification from the Federal Agency for Medicines and Health Products (FAMHP) for its facilities in Jumet, Belgium.
The accreditation follows a series of inspections ensuring the company can manufacture biopharmaceutical products according to GMP standards. It will enable the company to extend its services to more customers, supporting early development to full scale manufacture.
Exothera was founded in 2020 with the aim of tackling two challenges manufacturers face in bringing advanced therapies to market: lack of production capacity and scarcity of bioprocessing expertise. Specific viral vector bioprocessing expertise is needed to addressing the more complex manufacturing processes required for cell and gene therapy manufacture. These challenges have historically raised costs and slowed development of therapies, the company says.
The company has worked on more than 28 projects for clients in the EU and US and has the space available to develop a further 9,000 sqm on the Jumet campus. It’s also considering options to grow internationally depending on client need.
“This GMP accreditation for our facility extension is the cornerstone of everything we have been building since the beginning. We are extremely proud of the amazing work done by all the teams,” says Exothera’s CEO Thibault Jonckheere. “It will not only allow us to welcome new customers whose products are in early development stage but will also allow all of our existing partners to meet their large scale manufacturing needs”.
The need to develop and manufacture billions of vaccines, together with an expected 30 drug approvals by the FDA in the next year at least, will put immense pressure on global manufacturing. Exothera hopes to play a significant role in addressing some of these capacity needs through its facilities.
