September 6, 2017 CDMOs are champions for customization of single-use equipment
From 21st to 25th August 2017, more than 1,000 bioprocessing experts from all over the world met for this year's The Bioprocessing Summit in Boston MA. Rentschler's Chief Scientific Officer, Dr. Stefan R. Schmidt, took part as speaker and as chairman of a session.
In his talk "Disposables in bioprocessing: catalogue or customization - options and limits of flexibility" Dr. Schmidt gave an overview about benefits and challenges of standardization and customization of single-use equipment in upstream and downstream processing. Numerous single-use components are available as off the shelf catalogue products which can be mass produced at competitive prices. If suitable catalogue products are missing or technical limitations and special biological requirements are existing, single-use equipment can be customized or on-purpose designed. Particularly CDMOs are champions for customization as they have to adapt to many different bioprocesses. But customization causes huge efforts in design and vendor qualification. Therefore, the decision for a customization must be carefully evaluated.
Based on own experiences, Rentschler has established a four-column strategy to decide between to catalogue or customization:
- Good understanding of technical feasibility and the limits of available Systems
- Sound evaluation of manufacturing processes and their critical parameters
- Stable relation to supplier with regular updates on prototypes and new developments
- Decision where benefits outweigh costs of customization
Finally, Dr. Schmidt gave an outlook on future developments which might benefit from miniaturized customized bioreactors for individualized therapy products.
Rentschler Biopharma SE
Dr. Cora Kaiser
Senior Director Corporate Communication