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ADC manufacturing: from clinical development to commercial
Pharmaceuticals

ADC manufacturing: from clinical development to commercial

Novasep CDMO Services For ADCs Banner

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

Novasep 3 Facts About ADCs Thumbnail
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!

ADC FAQs Thumbnail

Discover the ADC generic drug names explained by Novasep:

Novasep ADC Generic Drug Names

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:

 Check out our case studies, technical article & watch our webinar recording to learn more about our ADC expertise:

Type of content

Title

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

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 studiesADC Fast Track Case Study CTA Novasep

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 packageADC DoE

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.

 

The Short Guide To Understand Novasep S CDMO Services For ADCs Thumbnail 2
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).

Novasep Le Mans Facility

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!

Novasep ADC Manufacturing Capabilities

ADC Brochure Japanese Banner Novasep

Downloads
  • ADC Bioconjugation: development and cGMP manufacturing of a candidate for Phase I clinical trials
    ADC Bioconjugation: development and cGMP manufacturing of a candidate for Phase I clinical trials
    Discover how we supported one of our clients with the cGMP bioconjugation of an ADC for Phase I clin...
    Download +
  • 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 +
  • 抗体薬物複合体(ADC)のCDMOサービス
    抗体薬物複合体(ADC)のCDMOサービス
    Find out the solution adapted to your needs with Novasep's fully integrated CDMO services for ADCs
    Download +
  • Frequently Asked Questions: ADCs
    Frequently Asked Questions: ADCs
    Learn more about ADCs in our FAQ!
    Download +
  • Case study: Successful cGMP conjugation of a Novel ADC for phase I clinical trials
    Case study: Successful cGMP conjugation of a Novel ADC for phase I clinical trials
    Novasep was approached by a top 10 pharmaceutical company to help with the manufacture of a cGMP ant...
    Download +
  • Report: PBD-Dimer Payloads for Antibody Drug Conjugates
    Report: PBD-Dimer Payloads for Antibody Drug Conjugates
    From the 1960s when monomeric PBDs such as anthramycin were isolated and characterized, to the drama...
    Download +
  • Case study: ADC payload, successful process development and manufacturing
    Case study: ADC payload, successful process development and manufacturing
    Novasep was approached by a top 10 pharmaceutical company looking for a reliable partner to manufact...
    Download +
  • Case study: Advanced Antibody Drug Conjugate characterization
    Case study: Advanced Antibody Drug Conjugate characterization
    Discover the internal platform method for fast ADC characterization, developed by Novasep's QC exper...
    Download +
  • Case study: Generation of first ADC lead candidates at lab scale to support pre-toxicology development program
    Case study: Generation of first ADC lead candidates at lab scale to support pre-toxicology development program
    Novasep was approached by a biopharmaceutical company developing a preclinical ADC consisting of IgG...
    Download +
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