CERBIOS further invests in high potency APIs manufacturing capacity 24th January 2019
Cerbios-Pharma’s board of directors has approved the detailed design and budget for the installation in its High Potency Active Ingredients (HPAPIs) dedicated building of a new production line able to accommodate larger volumes and batch size.
Cerbios is active in the HPAPI arena since 1993 with an established expertise on handling Category 4 SafeBridge (OEL<10 ng/m3) Drug Substances in four different lines: 2 non cGMP ; 2 cGMP.
The P5 building for larger scale cGMP production of HPAPIs was originally conceived with empty spaces available for installing an additional production line.
The new production line will be Category 3 Safebridge for batches ranging 5-30 kgs/ batch.
The new unit will be partially occupied for the manufacturing of an HPAI where larger volumes are required thus decreasing the production costs compared to the actual setup. The remaining capacity will be available for our CDMO services and partners.
“With 25 years of experience handling HPAIs, Cerbios’ reputation for its know-how and proficiency is bringing an increased number of partners’ projects for the development and manufacturing of clinical material as well as commercial production“, confirms Dr. Gabriel Haering, CEO. “Considering the conjugation suite for Antibody Drug Conjugates ready this summer and this new production line due in the second half of 2020, our offer to our partners will be six HPAPI production units in a single site with space available for future expansions if needed”.
In fact, Cerbios supports its partners from the production of non cGMP batches needed for preclinical tests, through clinical to commercial supply applying state-of-the-art Project management system and Quality by Design approach that are paramount to the success of a production campaign and process evolution beyond the registration phase.