Jeff Heiser

Company: BA Sciences

Job title: Chief Scientific Officer of Microbial and Advanced Therapeutic Platforms

Seminars:

CMC Considerations for Consortia Based LBP Programs – Streamlining Early Phase Analytics to Ensure IND Acceptance 4:00 pm

·      It is important to effectively characterize an LBP process to ensure IND acceptance in a timely manner. ·      How do you balance phase appropriate qualification with comprehensive characterization initiatives? ·      What are some of the challenges with performing stability studies on products that contain live microorganisms? ·      Purity assays, such as USP <61> and <62> seem like they…Read more

day: Conference Day One