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

Time: 4:00 pm
day: Conference Day One


·      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 are easy, but can be quite challenging with LBP consortia’s contain facultative anaerobes. How do we overcome those challenges?

·      Partnering with an analytical expert ensures the analytical panel utilized will be accepted by regulatory authorities.