We use cookies to ensure that we give you the best experience on our website. If you continue without changing your settings, we'll assume that you are OK with this.     OK  No, I would like to know more...
Home / Products & Services / Pharmaceuticals / CDMO services for High-Potency APIs
CDMO services for High-Potency APIs
Pharmaceuticals

CDMO services for High-Potency APIs

Novasep ADC Manufacturing

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

Novasep High Potency APIs Manufacturing


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

Novasep Services For ADC Payloads

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

Novasep CDMO Services For ADCs


HSE compliance

  • 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)

Novasep EHS Compliance



Downloads
  • A full range of CDMO services for ADCs
    A full range of CDMO services for ADCs
    Find out the solution adapted to your needs with Novasep's fully integrated CDMO services for ADCs
    Download +
  • A full range of CDMO services for APIs
    A full range of CDMO services for APIs
    Novasep provides flexible development and manufacturing solutions for small molecules APIs and advan...
    Download +
  • Frequently Asked Questions: ADCs
    Frequently Asked Questions: ADCs
    Learn more about ADCs in our FAQ!
    Download +
  • Frequently Asked Questions: HPAPIs
    Frequently Asked Questions: HPAPIs
    Learn more about HPAPIs in our FAQ!
    Download +
  • A full range of CDMO services for HPAPIs
    A full range of CDMO services for HPAPIs
    Find out more about Novasep’s expertise in the development and manufacturing of HPAPIs
    Download +
Contact

A question ? A request ? Leave us a message !

Contact us
You can stay on this page and select more documents or you can directly download the brochure(s) you selected

Your brochure is ready!

X

You can stay on this page and select more documents or you can directly download the brochure(s) you selected

Give us your feedback!