Antibody Drug Conjugates (ADCs) are a new class of biopharmaceutical drugs designed as a targeted therapy.
ADCs are complex molecules composed of:
- An antibody: a whole monoclonal antibody (mAb) or an antibody fragment such as a single-chain variable fragment
- A stable chemical linker with labile bonds
- An active cytotoxic payload
Click on this image to discover
3 facts about Antibody Drug Conjugates!
By combining the unique targeting capabilities of monoclonal antibodies with the cancer-killing ability of cytotoxic drugs, antibody drug conjugates allow sensitive discrimination between healthy and diseased tissue.
Discover all the answers to your questions about ADCs in our FAQ!
Discover the ADC generic drug names explained by Novasep:
The production of such complex products requires both biological and chemical know-how: Novasep offers a full range of integrated CDMO services for ADCs including payload and conjugation.
Watch the video below to learn more about our ADC manufacturing services:
Our ADC conjugation expertise
Novasep has been a leading contract service provider in the ADC arena for more than 15 years:
- Our commitment to ADCs is underlined by the recent €11M investment in a stand-alone bioconjugation unit at our Le Mans site in France.
- The Le Mans site has more than 30 years of experience in cytotoxics synthesis and industrial chromatography to address the challenges of ADC payload manufacturing.
- Novasep has also been awarded as a Runner-up for Best Contract Manufacturing (CMO) Provider at the 2018 World ADC awards.
Check out our case studies, technical article & watch our webinar recording to learn more about our ADC expertise:
Our ADC manufacturing solutions
Novasep offers a full and flexible range of ADC manufacturing services, from process development & analytical support to cGMP production:
Fast track offer for preclinical studies
One ADC sample with RoA
- Batch size: 10 to 100 mg
- Platform analytical methods
- 6 weeks turnaround time
- Recommendations for further process & analytical developments
Phase I package
BDS for First in Human Clinical Trials
- Batch size: 100 to 500 g cGMP scale
- GMP Documentation: CoA, Executed Batch Record
- Process and analytical development
- Stability Studies: BDS and DP, Preliminary Tabular Data
Watch our webinar recording to discover the importance of Design of Experiments (DoE) for your ADC
Clinical and validation package
- Process and analytical validation
- Registration batches
- BLA regulatory support
Custom package
Our dedicated team can tailor a custom manufacturing package to your specifications. We will work with you to create a scope of work to complete the project on time and within
specifications.
Click on this infographic to learn more about our ADC manufacturing offer
Our ADC bioconjugation unit
Our purpose-built ADC manufacturing facility is located in Le Mans (1 hour away from Paris, France by train).
This state-of-the-art facility is fully operational since the beginning of 2017 and is conveniently located on the same site as Novasep’s ADC payload services.
Our ADC manufacturing capabilities
To learn more about Novasep’s ADC capabilities, download our ADC brochure!
