James Blackwell, President, Windshire Group, LLC, explores common challenges in cross-functional process development. James is a leading industry consultant with broad chemistry, manufacturing, and controls experience in product development and quality that encompasses early process development to commercial operations for all major therapeutic classes.
Topic covered include:
1:28 – Common stumbling blocks in developing an effective bioprocessing operation
2:18 – Should upstream and downstream processes be developed concurrently or separately?
3:02 – Factors to consider when scaling up a process
4:32 – Factors to consider when scaling out a process
6:05 – Challenges encountered when different process steps are located at different geographically distant facilities or outsourced locations