Sunday, 14 August 2022

Exothera bags GMP certification

25 March 2022 | News

Further extends viral vector manufacturing capacity

Exothera, a CDMO specialised 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. The accreditation follows a series of successful inspections ensuring that Exothera can manufacture biopharmaceutical products according to the highest quality standards. This will enable Exothera to extend its services to more customers, supporting biopharma companies from the early development of biotherapeutic candidates to full-scale manufacture.


Initial operations began at two 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 one of Europe's largest state-of-the-art facilities with a GMP qualified manufacturing area totalling 2,100 m² (22,600 ft²) in just 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 giving clients great flexibility and choice.


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