- A new production line for larger volumes and batch sizes will be added to the HPAI dedicated building.
- The new line will handle Category 3 SafeBridge batches ranging from 5-30 kgs.
- Completion of the new production line is expected in the second half of 2020.
- The remaining capacity will support CDMO services and partners.
New Production Line Installation
Cerbios-Pharma has approved the design and budget for a new production line in its High Potency Active Ingredients (HPAIs) dedicated building. This line will accommodate larger volumes and batch sizes, enhancing the company's manufacturing capacity.
Expertise and Capacity
Active in the HPAI sector since 1993, Cerbios has expertise in handling Category 4 SafeBridge Drug Substances across four lines: two non-cGMP and two cGMP. The P5 building, designed for larger scale cGMP production, was initially planned with space for an additional production line.
New Line Specifications
The new production line will handle Category 3 SafeBridge batches ranging from 5-30 kgs. It will partially manufacture an HPAI requiring larger volumes, reducing production costs compared to the current setup. The remaining capacity will be available for CDMO services and partners.
Timeline and Future Plans
The new production line is expected to be operational in the second half of 2020. This addition will bring the total number of HPAI production units at Cerbios to six, all located on a single site with space for future expansions if needed.
Comprehensive Support
Cerbios supports its partners from the production of non-cGMP batches for preclinical tests through to clinical and commercial supply. The company employs a state-of-the-art project management system and a Quality by Design approach, ensuring the success of production campaigns and process evolution beyond the registration phase.
