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The short guide to understand Novasep's CDMO services for ADCs
Pharmaceuticals

The short guide to understand Novasep's CDMO services for ADCs


The Short Guide To Understand Novasep's CDMO Services For ADCs - Infographics

From clinical to commercial phases

Fast track offer for preclinical studies 

One ADC sample with RoA

1-100 mg ADC sample

Platform analytical methods

6 weeks turnaround time

Phase 1 package 

First in human clinical trials

100-500 g cGMP scale

Stability studies

Process and analytical development

Phase 2 / 3 package

Clinical and validation Package

Process and analytical validation

Registration batches

BLA regulatory support

 

Integrated production site

1. Dedicated facilities for payload and conjugation

2. More than 15 years of cGMP manufacturing

3. State of the art bioconjugation facility

4. Excellent regulatory history

Le Mans, France: payload-linker and bioconjugation

 

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Downloads
  • 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 +
  • 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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