Chris Broomell
Company: Omega Therapeutics
Job title: Head of Analytical Development
Seminars:
Panel Discussion: Navigating the Phase Appropriate Regulatory Prospective & Expectations of Potency Assays to Meet CQAs & CPIs to De-Risk Regulatory Submissions 12:00 pm
What is the phase appropriate expectation for potency assays? Protein expression versus activity-based methods What is the feedback on potency assays when using cell lines that do not match the site of indication? Debating the need to measure the potency of each component or drug substance of an mRNA-LNP, compared to just formulated drug product…Read more
day: Conference Day One
Roundtable Discussion: Invigorating QC-Friendly Practices & Workflows to Improve the Transfer of Analytical Methods & Expedite Regulatory Compliant Method Qualification 4:10 pm
Determining the phase-appropriate readiness of an analytical methods for method transfer and QC qualification Assessing fitness for use, key quality parameters, and method robustness to streamline and de-risk qualification Optimizing mRNA assays for scalability and consistency in quality control operationsRead more
day: Conference Day One