Guest Columns & From The Editor

41. Inside Cell & Gene Live “How To Reduce Batch-To-Batch Variation In Cell Therapy Manufacturing” 2/26/2024

    Here's a recap of our recent Cell & Gene Live, How to Reduce Batch-to-Batch Variation in Cell Therapy Manufacturing, featuring expert panelists, Omkar Kawalekar, Ph.D., Head of Manufacturing and Supply Chain at NextGen Therapies Consulting at Deloitte and Donna Rill, Chief Technology Officer at Triumvira Immunologics.

42. Mass General Cancer Center’s Dr. Genevieve Boland on Amtagvi Approval 2/26/2024

    The FDA’s approval of Amtagvi addresses an unmet need in melanoma patient care. Here, Genevieve Boland, M.D., Ph.D., from Mass General Cancer Center shares her insight on the approval.

43. Process Mapping For More Effective Knowledge Management 2/26/2024

    It takes a patchwork of knowledge from multiple complementary mapping tools to generate the process knowledge needed for success in pharmaceutical and biologics manufacturing.

44. Site Feasibility Tips For Cell And Gene Therapy Clinical Trials 2/22/2024

    Site feasibility assessment can be challenging. Therefore, it’s essential to have a solid understanding of the regulatory obligations for investigators and sites when it comes to choosing each. 

45. Understanding And Navigating Diverse Regulatory Environments 2/21/2024

    Drug developers aspire to treat patients globally, but navigating diverse regulatory structures around the world gets tricky. These consultants offer a primer on the regulatory bodies of the world.

46. A Novel Approach To Managing Risks In Aseptic Processing Of Cell & Gene Therapies 2/21/2024

    Establishing a robust contamination control strategy for advanced therapy medicinal products, also referred to as cellular and gene therapy products, is of utmost importance. We must employ risk assessments and risk-based approaches. In this article, the authors introduce the aseptic risk evaluation model (AREM), which is compliant with the evolving global regulatory landscape and best practices.

47. Let’s Clean Up That Bioburden — The Aseptic Suite’s Persistent Plague 2/16/2024

    After decades of helping to rescue biotech and pharma companies from environmental monitoring excursions, Herman and Erich Bozenhardt bring this discussion about specific problems you should avoid.

48. A Data-Derived Approach For Selecting Criticality Levels In FMECAs For Cleaning Process Risk Analysis 2/16/2024

    The ASTM E55 Cleaning Team, in collaboration with F04 Medical Device Committee members, felt that the commonly used three-level criticality system was inadequate for use in a science- and risk-based standard for cleaning process development, validation, and monitoring. This article will provide a detailed discussion of how science-based and data-driven criticality levels were derived, the meaning of each level, and how they can be used for guiding the selection of risk reduction and risk control measures.

49. FDA’s CBER Issues Final Guidance For CAR T Cell Products 2/15/2024

    The FDA issued the final guidance document, Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products, on January 29. This article shares a useful and thorough summary of the guidance and where it differs (or not) from the earlier draft version of the guidance.

50. New DSCSA Guidance Details Layers Of Verification System Requirements 2/15/2024

    A recent FDA final guidance interpreting the DSCSA details verification systems expectations for trading partners. Just how they should meet these expectations, however, remains unclear.