HPAI Services
Chemical Division
High Potency Active Ingredients Services
With over 25 years' expertise in industrial scale manufacturing of APIs and over 10 years' experience in handling HPAIs according to cGMP, Cerbios is highly qualified in process development of new APIs and HPAIs up to industrial and commercial production.
During the last few years, Cerbios has made substantial investments in infrastructure to strengthen and extend its activities and services in the field of HPAIs.
Today, Cerbios can provide state-of-the-art services needing high containment technologies. All facilities operate according to the current cGMP of highly regulated markets like USA, EU and Japan.
Our specific contract manufacturing services in the area of HPAIs include:
- Technology transfer from our partners to Cerbios
- Chemical process development and scale up
- Production of cGMP material for clinical trials and commercial supply
- R&D support (impurities isolation, identification and synthesis; reference standards…)
- Analytical methods development and validation
- Full regulatory support for IND, NDA, ANDA, DMF, CEP and Japan-DMF submission
The high containment activities are supported by Intellectual Property (IP), Logistics as well as HSE (health, safety and environment) services to guarantee full responses in all stages of development.
The facilities consist of the following production units and equipment:
- Small manufacturing plant for 1-50 grams cGMP batches including preparative medium-pressure chromatographic system
- Kilo plant for up to 1 kg batches including a preparative High Pressure Liquid Chromatography system designed to purifiy HPAIs (starting materials, intermediates or final APIs), a Photoreactor and cryogenic capabilities (-60°C).
All containment facilities are designed based on a modern zone concept with pressure cascades, airlocks and access controls. This allows the safe handling of highly-potent compounds of all categories including cytostatics (not cytotoxic).
