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 / ADC payloads manufacturing and development services
ADC payloads manufacturing and development services
Pharmaceuticals

ADC payloads manufacturing and development services

Novasep CDMO Services For ADC Payloads Banner

A payload
is the cytotoxic agent which is conjugated to a target-specific monoclonal antibody through a covalent linker molecule to produce an ADC. Such biomolecules result in a target-tracking pharmaceutical showing strong efficacy in cancer therapies.
ADC payloads are usually complex structures produced through a 10-20 step synthesis process or by hemisynthesis. Given that the purity of the payload has a direct impact on the quality of the ADC, the production of these compounds with a high purity is the main challenge. 
Production of HPAPI’s such as ADC payloads requires a contained and specially designed environment along the development & manufacturing process including R&D, analytical, production and storage.

With more than 15 years experience, Novasep is today a commercial supplier of ADC payloads with a demonstrated track record of success in the synthesis and the purification with the main classes of payloads (Maytansines (DMx), Auristatins, PBDs) & other customer-proprietary toxins.

A strong track record in ADC payloads manufacturing 

Novasep has a proven track record in the development and commercial production of ADC payloads: 

Track record in the main classes of ADC payloads 

  • Over 15 years cGMP payloads production
  • More than 150 clinical & commercial cGMP batches
  • Maytansines (DMx)
  • Auristatins
  • Pyrrolobenzodiazepines (PBD dimers)
  • Customer proprietary payloads

Purification of complex molecules 

  • Expertise in HPLC purification is a necessity for the manufacture of ADC payloads
  • World leader in HPLC chromatography

Novasep ADC Payloads Purification

Extremely high toxicity of the final products and intermediates

  • Le Mans facility equipped to handle compounds with an OEL below 30 ng/m³/8hrs for R&D, small & large scale production and QC

Flexible cGMP production capabilities

  • Small scale & large scale workshops
  • 30g to 1kg per batch
  • Wide range of synthesis & purification equipment
  • Experience in process scale-up from bench to large scale and successful process validation at small & large scale 
  • Last FDA inspection: No 483

Novasep Services For ADC Payloads

Our ADC payload solutions

Novasep offers a full range of ADC payloads manufacturing services, from process development to cGMP production:

R&D laboratories

  • Analytical & process transfer / Familiarization
  • Process & analytical development
  • Process characterization
  • DoE – Design of Experiments (more information – faster – using less product)
  • Batch size: Up to 10g

Kilolabs

  • cGMP production for clinical trials
  • Process validation
  • cGMP production for commercial supply
  • Batch size: Up to 500g

Large-scale production

  • cGMP production for clinical trials
  • Process validation
  • cGMP for commercial supply
  • Batch size: Up to 1kg

Quality control

  • Method development, transfer and validation
  • IPC
  • Release testing
  • Stability studies

Novasep ADC Payload Case StudyDownload our case study about the successful process development and manufacturing of an ADC payload to learn more about our expertise!

 

Our centre of excellence for ADCs

Located one hour from Paris by high-speed train, our Le Mans manufacturing site benefits from more than 30 years of experience in HPAPIs and industrial chromatography.
The site offers a full range of ADC payloads and bioconjugation services.
Having ADC payloads manufacturing and bioconjugation on the same site brings chain simplification, timeline and cost optimization, and risk reduction (no shipment of the highly potent material, no border to cross, etc.).
This centralized activity also allows a better project management, with one global development contract and quality agreement.

Novasep Le Mans Facility

 

Our latest investments for ADC payloads & bioconjugation

A plant extension for ADC payloads manufacturing (4M€)

  • Chemistry workshop (reactions down to -60°C)
  • Purification capabilities for potent and extremely potent ADC payloads (two separate Prochrom® preparative HPLC lines)
  • Commercial scale with an OEL lower than 30 ng/m³/8hrs
  • Multi-kg scale per batch
  • Le Mans, France
    Learn more about this investment

Novasep Le Mans Site 1

A new antibody drug conjugate (ADC) bioconjugation unit (11M€)

  • Clinical and commercial ADC manufacturing
  • R&D services, QC and scale-up laboratories
  • Two flexible GMP production suites (10L to 400L vessels)
  • Purpose-built facility
  • Le Mans, France
    Learn more about this investment

Novasep New ADC Bioconjugation Unit

Downloads
  • Case study: ADC payload process development and manufacturing
    Case study: ADC payload process development and manufacturing
    Novasep was approached by a top 10 pharmaceutical company looking for a reliable partner to manufact...
    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 +
  • 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 +
  • 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 +
  • 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 +
  • 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 +
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!