Highly Active Products
CEPiA offers to customers to have their Highly Active Product (HAP) projects handled by the same experts who developed and manufactured the two marketed drugs: Docetaxel (Taxotere®) and Cabazitaxel (Jevtana®).
Our high level of expertise acquired through solid and long lasting experience in handling cytotoxic compounds is strongly set on four principles:
- Extensive knowledge in Chemistry
- State-of-the-art facilities
- Highly trained team
- Environment, Health and Safety experts
We are committed to sharing our scientific knowledge and experience in pharmacology and toxicology to support your project. Our internal team of experts in industrial hygiene can assess OEB* categorization for APIs and upstream intermediates only when necessary to minimize costs.
We apply the OEB* index from 1 to 5 relative to the product toxicity. OEB* index corresponds to an OEL** range (see the following table).
*OEB: Occupational Exposure Brand
**OEL: Occupational Exposure Level
Our facilities for highly active compounds manufacturing are located near Paris (France), operated under cGMP procedures and are governed by Sanofi Quality Control.
On the same site, two production units are suitable for technical transfer and process development, small scale production and large industrial scale manufacturing.
These two units are operated in Iso 7 classification for OEB 4 and OEB 5 compounds and are regularly inspected by Health Authorities, including FDA, EMA & PMDA.
All the production lines are equipped with the latest technologies in isolators, glove boxes, vessels and drying equipment. Machinery is fully or partially segregated with air control systems satisfying the most stringent requirements for product and personnel protection.
Our volume range is 5 - 1 000 L reactors in stainless steel, hastelloy and glass-lined for a total of 39 reactors (total volume of 10 m3).
Upon request, we provide milling and micronization services for HAP in Iso 7 room.
The total staff is nearly 80, working in one or two shifts. Highly trained personnel are recognized for their ability to work meticulously and safely in contained environment.