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