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Accreditation further extends CDMO's viral vector manufacturing capacity
Exothera S.A., a contract development and manufacturing organization (CDMO) that specializes in the development and manufacture of viral vectors for vaccines and gene therapies, has received good manufacturing practice (GMP) certification from the Federal Agency for Medicines and Health Products (FAMHP) for its facilities in Jumet, Belgium.
The designation will allow Exothera to extend its services to more customers, supporting biopharma companies from the early development of a biotherapeutic candidate, to full-scale manufacture.
Initial operations began at two sites located in Nivelles and Gosselies (also in Belgium), 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 offer a combined area of 92,570 square feet. Exothera—together with Univercells' team and selected partners—has built a GMP qualified manufacturing area totaling 22,600 square feet in 18 months.
“ … 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.”