Exothera, a CDMO specializing in the development and manufacture of viral vectors for vaccines and gene therapies, received Good Manufacturing Practices (GMP) certification from the Federal Agency for Medicines and Health Products (FAMHP) for its facilities in Jumet, Belgium. Company officials say Exothera will now be able to extend its services to help more customers, supporting biopharma companies from the early development of biotherapeutic candidate to full scale manufacture.
According to Thibault Jonckheere, CEO, Exothera was founded in 2020 to help tackle two of the most critical challenges manufacturers face in bringing advanced therapies to market: a lack of production capacity and scarcity of bioprocessing expertise.
Initial operations began at two Belgian sites located in Nivelles and Gosselies while renovation and construction of new offices and large process development and production areas took place in two buildings on the Univercells campus in Jumet. These facilities now provide a combined area of 8,600 m² (92,570 ft²).
Exothera, together with Univercells’ team and selected partners, has built facilities with a GMP-qualified manufacturing area totaling 2,100 m² (22,600 ft²) in 18 months. The facility includes five upstream grade C clean rooms with several bioreactor technologies for adherent and suspension cell culture. The bioreactors can go up to 2 x 2,000L for the suspension platform and 2 x 600m² (2 x 6,450 ft²) for the adherence platform.
Exothera reports that it has already worked on more than 28 projects for clients in the EU and US and has the space available to develop a further 9,000 m² (96,900 ft²) on the Jumet campus plus other options. The company is also considering plans to grow internationally depending on client needs.
“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 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”.