Cell and Gene Regulatory

31. Solving The Stem Cell Consistency Conundrum With iMSCs 11/17/2025

    The ability to produce unlimited batches of induced mesenchymal stem cells from a single iPSC cell bank is, perhaps, one of their most alluring features.

32. Sensitive Critical Starting Materials Need A 'Just-In-Data' Approach 11/14/2025

    Here's a blueprint for transforming the fragmented, high-risk interface between vector and cell therapy platforms into a unified, predictable, and compliant system.

33. Annex 1: Ensuring Sterile Pharmaceutical Manufacturing Standards 11/13/2025

    Adhering to the rigorous standards set by the EMA's Annex 1 requires strategic, risk-based compliance for facility design and processes, all of which is key to patient safety and future innovation.

34. On The Potency Assurance Journey, Travelers Need A Road Map 11/13/2025

    When regulatory expectations change by the phase, the route can be difficult and confusing to navigate for both new and experienced potency investigators.

35. Why Manufacturing And Quality Are Critical To Meeting FDA Expectations 11/12/2025

    CMC failures are a top reason for BLA rejections in cell and gene therapy. Learn proactive strategies to spot subtle quality gaps and ensure your manufacturing aligns with strict FDA expectations.

36. Managing Complex Data In Process Development And CMC 11/12/2025

    Learn how automated platforms streamline data capture, integration, and analysis—enabling better decisions, improved consistency, and faster workflows across CMC and process development.

37. Designing Viral Clearance Studies By Phase, Modality, And Regulation 11/12/2025

    Gain practical strategies and regulatory insight on viral clearance studies, including virus selection, performance benchmarks, case studies, and submission-ready data for biologic products.​

38. It's Not Just You, Everyone's Talking About OPV 11/12/2025

    Ongoing process verification has evolved beyond a compliance exercise to a strategic priority thanks, in part, to technology advancements.

39. A Straightforward Path Toward Regulatory Compliance & Data Integrity With Your Microbial Testing Systems 11/10/2025

    In this webinar, we will share a variety of strategies for implementing and validating microbial identification systems in the cGMP environment, possible difficulties along the way, and a comprehensive solution that addresses these challenges.

40. Driving Sustainability In Bioprocessing With Biobased Single-Use Solutions 11/7/2025

    Discover how biobased materials in bioprocessing enable measurable carbon emission reductions. Learn practical strategies to meet decarbonization goals and adopt greener, operationally sound practices.