Novasep

39 Rue St Jean de Dieu, Lyon, Auvergne-Rhone-Alpes, 69007

ADC payloads manufacturing and development services

ADC payloads manufacturing and development services

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, Camptothecins (CPT), 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
Camptothecins (CPT)
Customer proprietary payloads

Purification of complex molecules

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

Extremely high toxicity of the final products and intermediates

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

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

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 chainsimplification,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.

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

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