API drug development and manufacture
We routinely provide a wide range of pharmaceutical customers with drug substance services that include:
- Rapid process implementation and drug substance supply through all phases of the product life cycle
- Fit for purpose process development and API scale-up
- Process validation and API manufacture
- The development and manufacture of highly potent APIs (HPAPI) requiring our specialized infrastructure and handling capabilities
- ADC payloads with the option of integrated services inclusive of monoclonal antibodies, linkers and conjugation services
All services are supported by a dedicated program management team and cGMP quality systems inspected by leading, global regulatory authorities.
Your containment partner
We are an acknowledged industry leader in the development and manufacture of highly potent APIs (HPAPI). Being one of the first CDMOs in the industry, we have extensive experience in handling HPAPIs, world-class HPAPI facilities and a 30+ year track record of successfully delivering HPAPI services to our customers.
At our facilities in Visp (CH) and Nansha (CN), we have a wide range of state-of-the-art HPAPI development and manufacturing capabilities and a highly trained and experienced team of chemists, analysts, engineers and plant operatives ready to work on your HPAPI program.
Our experience and expertise in HPAPI handling also extends to particle engineering (micronization) and development of specialized dosage forms for low dose and HPAPI applications.
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