Training Overview
The environment for recombinant proteins used as biotherapeutics is changing. In the context of developing new biological entities, the bioindustry should further improve speed to clinic,
gain in manufacturing flexibility while reducing costs of good sales (COGS).
Despite at start of the recombinant era in the 80s/90s, continuous upstream processes have been applied especially for sensitive molecules such as hormones, cytokines and blood factors, the development of monoclonal antibodies as drugs was mainly based on large-scale fed-batch upstream connected to chromatography-based purification operated in batch. However, since the last ten years, it seems that the productivity of manufacturing processes of recombinant proteins based on large-scale fed-batch and classical chromatography processes has reached a plateau. As new technologies in cell separation and automatization of chromatographybased processes emerged, continuous manufacturing becomes a valid option for improving manufacturing productivity, flexibility and COGS.
Whereas continuous manufacturing is now well considered for small molecules, it is not yet the case for biologics. Despite, some challenges still exist in applying continuous manufacturing processing for biologics, that approach could address some of the current limitations of largescale fed-batch processes.
Key Takeaways:
- Setting-up the context of the bioindustry leading to develop and implement new manufacturing technologies for recombinant proteins
- Understand the upstream and downstream manufacturing technologies, past, present and future, their respective benefits and drawbacks
- Propose methods to build up a continuous process
- Understand the benefits of applying continuous manufacturing (regulatory flexibility, manufacturing flexibility, productivity and economics)
Who should attend?
Big, media and small size pharma companies, medical device companies, biopharma companies
from all around Europe.
• Process development scientists and managers
• CMC development program managers
• Manufacturing managers
• QC and stability control managers
• Heads of Quality Assurance
• Drug Regulatory Affairs managers
Trainer
