Monoclonal Antibodies

Experts in development and production of mAbs

Expertise - Troubleshooting - Training

Monoclonal Antibodies

The global market for monoclonal antibodies (mAbs) is expected to continue to develop over the next few decades.
Many companies, start-ups and pharmaceutical companies are developing new therapeutic mAbs. At the same time, regulatory requirements are becoming more stringent in order to ensure effective and safe products

Axys-Network can draw on its technical knowledge and extensive experience in the biotechnology sector, from the start of product development to commercial and routine manufacturing.
Process Development

  • Process development: how to get a reliable and efficient process
  • Scale-up to commercial lots
  • Process characterization studies
  • Viral risk and vCJD mitigation strategy
  • Definition of the design space and determination of key parameters
  • Implementation of a process control strategy (PCS)
  • Process validation
  • CMC and inspection support
  • CMO interface
Process improvement
  • Process improvement and optimization to increase performance and safety
  • Process characterization studies
  • Technical transfer
  • Product Comparability Pack
  • Troubleshooting and technical investigations
  • CMC and inspection support

Other services 

Take advantage of experienced experts and benefit from their experience

Annexe 1
CMO CDMO Selection
Downstream Processing
Protéin Aggregation