Industry Insights

  1. Gene Therapy Remains On Course To Broadly Transform Medicine 2/1/2023

    AVROBIO's President and CEO, Geoff MacKay, explains three themes he expects to play out for the gene therapy industry in 2023.

  2. After Decades Of Biomanufacturing Workforce Development, What’s Next? 2/1/2023

    We have seen exponential growth of the biotech industry in recent decades. Companies have struggled to find qualified workers. To close that workforce gap, we need to leverage the lessons from successful biomanufacturing training programs and consider new approaches.

  3. 4 “Hot Takes” On Cell & Gene Therapy Manufacturing From Advanced Therapies Week 2023 1/24/2023

    There is truly no article more difficult to write than a takeaway article from a conference. But as I recently spent the past week attending various panels and hearing different perspectives at Phacilitate’s Advanced Therapies Week, I wanted to attempt to do “the impossible” (for me): Share four of the burning manufacturing takeaways that jumped out at me most during the week.

  4. How Do Cell & Gene Therapy Requirements Differ Between FDA & EMA? 1/24/2023

    This article examines the similarities and differences between how the FDA and the European Medicines Agency (EMA) approach cell and gene therapies. Where do the regulatory perspectives align and where do they diverge?

  5. The Promise Of Outcomes-Based Agreements For Cell & Gene Therapies 1/20/2023

    There is a pressing need for stakeholders to find cost-effective ways to help more patients gain access to cell and gene therapies. While many types of innovative payment models exist, outcomes-based agreements — in which manufacturers and payers agree to specific performance and outcome metrics — are emerging as an attractive best practice option for both parties.

  6. The Holistic Guide To Supply Chain For Cell & Gene Therapy Startups 1/19/2023

    How does the cell and gene therapy supply chain team stay ahead of the expected changes and respond at the speed the developing program expects? Supplier selection, raw materials, built-in quality, warehousing and logistics, and traceability are all covered in this article.

  7. EMA's Revised GMP Annex 1 Addresses Common Global Challenges for Sterile Products 1/18/2023

    The new EMA GMP Annex 1, “Manufacture of Sterile Medicinal Products," is in line with other international regulations, e.g., ICH and PIC/S. FDA involvement in its writing is a clear indication that the contents will be the FDA position in general terms. Fortunately, the annex contains many checklists to help you assess and remedy your systems.

  8. FDA Releases Final Guidance On Early-Phase Cell & Gene Therapy Trials 1/18/2023

    The cell and gene therapy development process involves screening different variants of a product type. To aid this process and to ensure that suitable evidence is gathered so that effective variants of the product are taken through to later-stage trials, the FDA has produced a final guidance, Studying Multiple Versions of a Cellular or Gene Therapy Product in an Early-Phase Clinical Trial.

  9. Revision Of The ASTM E3263 Standard For Visual Inspection Of Pharmaceutical Manufacturing Equipment And Medical Devices For Residues 1/17/2023

    ASTM has published the revision of ASTM E3263 "Standard Practice For Qualification Of Visual Inspection Of Pharmaceutical Manufacturing Equipment And Medical Devices For Residues.” This article, written by the ASTM revision team itself, explains the reasons behind the revision and delves into the key updates.

  10. Defining The RNA Therapeutics Industry In 2023 1/16/2023

    Four executives outline which industry challenges, strategic considerations, and opportunities should be top of mind as RNA therapeutics companies establish their to-do lists for 2023.