This webcast features: Steven Perry, PE, Senior Director of Manufacturing Sciences, Catalent Biologics
Biologic drug substance development and biomanufacturing is a critical step in the long, complex pathway to approval. There are many considerations to be made around cell line and process development, analytical testing and late stage activities such as process characterization and validation.
This presentation discusses:
- Critical drug substance resource needs of sponsor companies
- How expertise and collaboration amongst the key stakeholders enables successful development and scale up
- Thinking ahead to what will be needed for successful Drug Product development and fill/finish
|More information about Catalent’s can be found in this Poster:
Step-wise strategy to address process characterization and late phase development – toward the definition of a standardized approach