Driven by growing demand for innovative oncology drugs, interest in High-Potency APIs (Active Pharmaceutical Ingredients) & cytotoxics continues to grow. The manufacturing of
High-Potency API requires specialized high containment facilities operated by highly qualified personnel. Strong HSE culture coupled with regulatory expertise is essential, ensuring the safety of both patients & employees.
By nature, HPAPIs are often complex molecules & need specialized technologies for multi-step synthesis and purification. Though traditionally associated with small molecule drugs, the recent development of biopharmaceuticals such as antibody-drug conjugates (ADCs), have provided new challenges for HPAPI manufacturers.
Novasep offers expert production and development services for your HPAPIs, cytotoxics and ADC payloads. We also offer unique services for the cGMP manufacturing of antibody-drug conjugates.
High-Potency APIs (HPAPIs) manufacturing
- A full range of CDMO services for HPAPIs & cytotoxics
- Extremely high toxicity of the final products and intermediates
- Flexible production capabilities under cGMP
- Collaborative approach
- Recognized expertise in industrial chromatography
Production and development services for ADC payloads
- Track record in the main classes of ADC payloads
- 15 years of experience in development and cGMP production
- Analytical and regulatory support
- Over 150 commercial and clinical cGMP batches
Antibody-drug conjugate (ADC) manufacturing
- A full range of CDMO services for ADCs
- A leading contract service provider in the ADC arena for more than 15 years
- ADC conjugation expertise
- ADC payload production and bioconjugation unit on the same site
- Depth of HSE culture & know-how
- Facilities inspected by the FDA, the ANSM (France) and PMDA (Japan) accredited
- Regular training and medical surveillance of our employees
- Standard Operating Procedures (SOPs)