Expert Insights on GCT Cold Chain Logistics

31. A Comprehensive Guide For Supplier Quality Agreements 10/29/2024

    This overview of SQAs includes a handy matrix template, which is useful for determining who is responsible for managing specific responsibilities.

32. Cell & Gene Therapies: Avoid This Common Pitfall In Supply Chain Planning 10/24/2024

    BioPhorum members propose a Design for Supply model for cell and gene therapy supply chain planning. Don't let it take a backseat until the later stages of the product life cycle.

33. What's Next After FDA's DSCSA Extension? 10/18/2024

    Facing growing pressure from industry and Congress, FDA extended its enforcement deadline yet again, which has important implications for manufacturers.

34. Data Quality Issues At The Heart Of FDA's DSCSA Troubles 10/18/2024

    Industry still struggles to manage complex data requirements, which forced the FDA to once again delay enforcement of the Drug Supply Chain Security Act.

35. What's In The Leukopak Matters For Cell Therapy Manufacturing 10/11/2024

    Advanced cell-based therapies are impossible without high-quality leukopaks from high-quality donors.

36. How Elixirgen Manufactures Hematopoietic Stem Cells At The Bedside 10/9/2024

    The company uses a mobile manufacturing system to produce autologous stem cell therapy for patients with dyskeratosis congenita and other telomere biology disorders.

37. A Guide To Selecting Cell & Gene Therapy Tools, Tech, & Services 8/15/2024

    These recommendations guide cell and gene therapy companies through the selection process for innovative tools, technology, and services with an eye to enable forward compatibility from early to later stages of development. 

38. DSCSA Implementation Is Progressing, But More Complexity May Be Coming 8/5/2024

    The FDA recently announced it would exempt small dispensers from requirements of the Drug Supply Chain Security Act (DSCSA) until Nov. 27, 2026. The industry has made tremendous progress so far with DSCSA, but this discretion will make compliance more challenging.

39. New 'WEE' Urgency Raised As FDA Requires DSCSA EDDS Interoperability 6/28/2024

    A June meeting showed industry is struggling to meet the DSCSA's November deadline. Eligible companies might find relief in an FDA waivers and exemptions program.

40. Sorting Through Winners And Losers Of New Technology In Pharma 5/30/2024

    Innovation and improvement are often used synonymously, but sometimes innovation hinders more than helps. Here’s a cold-eyed look at recent blockbuster tech advances.