Preparative HPLC for GMP manufacturing operations in high containment allow purification of up to Safebridge category 4 HPAPIs
This well-known technology, normally used during the early-stage development of New Chemical Entities and payloads for ADC, is available at the Cerbios site for lab-scale method development operations and for industrial-scale purification of Highly Potent Active Ingredients (HPAPIs) in a cGMP environment, qualified for high containment up to category 4, (OEL < 30 ng/m3), according to the Safebridge categorization system.
The setup of the Cerbios’ GMP manufacturing units allows for the purification of batches of up to 5 kg, which in most cases is suitable for the commercial-scale production of potent compounds. The technology is offered by Cerbios in combination with the production of HPAPIs and not as a stand-alone service.
The key advantages of using this purification method are:
- Higher yields compared to crystallization.
- Quicker turnaround with positive impact on development phases.
- Potent control strategy to meet target quality requirements of desired compound
- Possibility to purify oily or low fusion products.
- Possibility to purify products that do not crystallize because of specific impurity content.
- Possibility to isolate impurities during the same run of product purification.
- Trade secret barriers