Novasep has become the third contract manufacturer in less than two months to announce potent compound safety certification. The certification, granted by SafeBridge, applies to portions of its Le Mans, France, facility used for the manufacture of highly potent active pharmaceutical ingredients.
In addition to the potent compound certification, Novasep has integrated facilities and expertise for monoclonal antibody production via its acquisition of Belgian CMO Henogen. The company can now claim complete and safe manufacturing solutions for antibody drug conjugates, from early development to commercial scale, according to an announcement.
The certification verifies Novasep's proficiency in the management, evaluation, containment, control and communication elements of HPAI production. It involves a 60-element review of API programs, procedures, containment and control. The certification applies to the R&D laboratories, the kilolab, a manufacturing scale synthesis area and associated quality control laboratories.
As reported earlier, DSM Pharmaceuticals and SAFC also have been recently certified.
- here's the announcement
- see our earlier coverage