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Biomanufacturing is housed in an ultra-modern Biosafety level 2 (BL-2), facility. This permits specialization in the customized production of clinical products such as recombinant viruses, cells, and proteins derived from bacteria, yeast, and mammalian cells that need a higher degree of containment. Formulation and filling capabilities for proteins and for live organisms (BL-2), including viruses, are available.
The facility is multipurpose with two separate, independent production zones for microbial and eukaryotic production.
The production areas comply with European and US regulatory requirements, and are capable of supporting and segregating different upstream and downstream manufacturing processes simultaneously.
The unit is cGMP compliant, EU 98/81 compliant, and has an ISO 9001/2000 certified quality system. It has also been certified by the Belgian Federal Agency for Medicines and Health Products (licence no. 641). The QC and QA group are independent from biomanufacturing. Batches for clinical trials are released by the Qualified Person.
Numerous projects have been successfully completed in recent years on behalf of major US and European biopharmaceutical companies.
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