ADC manufacturing

ADC manufacturing: from clinical development to commercial

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

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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.

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Top 6 qualities to look for in a CDMO partner for ADCs

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:

Type of content	Title
Case study recording	Maleimide cysteine based ADC
Case study	ADC bioconjugation: Development and cGMP manufacturing of a candidate for Phase I clinical trials
Case study	Advanced ADC characterization
Technical article	PBD-Dimers Payloads for Antibody-Drug Conjugates: A robust approach to cGMP production
Case study	Successful process development and manufacturing of an ADC payload from Phase I to commercial
Case study	Generation of first ADC lead candidates at lab scale to support pre-toxicology development program
Webinar recording	When to apply Design of Experiments (DoE) to ADC development

Discover the ADC generic drug names explained by Novasep:

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.

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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.