Clinical Supply Manufacturing Articles

31. July Update — U.S. Generic Drug Tariffs: Implications For Pharma And Outsourcing 8/7/2026

    Mathini Ilancheran updates us on how delayed U.S. tariffs on generic drug imports could reshape supply, sourcing, and trial planning.

32. When Does GMP Matter In Non-GMP Settings? 4/5/2024

    Would you ever need to follow GMP standards in workspaces where GMP is not required or possible? This article digs into why, when, and how to follow the principles of GMP.

33. Making Cancer Vaccines Is Complex; New Platform Guidance Could Help 7/3/2024

    FDA's draft guidance on platforms is mostly for established, well-characterized modalities, but it also has implications for the emerging area of personalized medicine.

34. Inside Arbor Biotech's In Vivo Gene Therapy Approach 8/6/2025

    Following recent news about first-in-human testing, two executives discuss the science and manufacturing strategy for the company's lead candidate, ABO-101.

35. Inside GCSG 2026: Clinical Supply Impact On Patient Experience 5/21/2026

    This GCSG 2026 event recap with Steve Jacobs (including video) highlights how clinical testing and supply decisions shape patient experience, among other buzzy topics.

36. Comparability Considerations For mRNA Product Development 2/28/2024

    Given the mRNA-based products' variability and unique challenges, you may need to modify the standard comparability approach. Let’s discuss strategies for any development stage.

37. 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.

38. Managing Supply Chain Risk In Scale-Up And Multisite Trials 1/23/2026

    Scaling trials across sites can lock in supply risk early. Learn how biologic variability, long lead times, and multisite complexity threaten trials and how to spot warning signs fast.

39. Challenges And Opportunities Of Outsourcing Biopharma Development 2/19/2025

    Oversight, knowledge management, and operational/compliance risk make up the three key challenge classifications to consider when approaching a new outsourcing agreement.

40. New DSCSA Compliance Blueprint Includes FDA & Industry Input 4/12/2023

    Pharmaceutical manufacturers, distributors, and pharmacies must all ensure they are ready for the Drug Supply Chain Security Act (DSCSA)'s full implementation starting on Nov. 27, 2023. The Partnership for DSCSA Governance, a public-private partnership, has published a blueprint compiling input from every sector, including FDA, industry, and solution providers.