25 years of experience in cytotoxics synthesis and industrial chromatography
to address the challenge of ADC payloads manufacturing
Custom development and manufacturing services for the production of Antibody-Drug Conjugate payloads
Novasep offers a full range of services for the production of ADC payloads ranging from process development to commercial scale manufacturing taking into account the additional specificity of these complex molecules.
Specific Production Challenges
ADC payloads typically present high toxicity at extremely low doses when unconjugated, resulting in very low Occupational Exposure Levels (OEL) to ensure workers protection. Novel payloads even present OEL lower than 0.03 µg.m-3.8h-1 (Safebridge® Category 4).
These complex molecules often present chemo-selectivity issues and variable stability under normal operating conditions. Their production requires chemistry carried out at small scale under high containment in a GMP compliant environment.
For these reasons, any activity related to ADC payloads production requires a contained and specially designed environment, including those for R&D, analytical, production, storage.
Experience and knowledge in production and purification of payloads for ADCs since 2006
Classes of ADC payloads produced by Novasep include:
- ADC linkers
Cytotoxics and ADC payload track record:
- 5 new projects in development on average each year
- 4 commercial parenteral APIs produced on site
- 2 novel commercial compounds launched in the past two years
Novasep has had several successful PAI audits, including one in 2009 and in 2013. Learn more about our quality management system.
New Facilities for Commercial Scale Production of ADC Payloads
The new production facility, dedicated to the production of ADC payloads, was commissioned in 2014. It includes a chemistry workshop with the capability to manage reactions down to -60°C and filter dryers fit for the production of kilogram-scale batches. The asset also includes a purification workshop with two separate Prochrom preparative HPLC lines. This new facility enables commercial production (kilogram-scale batches) of payloads with a OEL 0.03 µg.m-3.8h-1 and lower under full cGMP conditions.