INSIGHTS ON CELL & GENE REGULATORY ISSUES

  • Regulators, Standards Groups Address Emerging Tech In Biopharma
    Regulators, Standards Groups Address Emerging Tech In Biopharma

    Manufacturers, suppliers, and regulators have recognized that introducing new technologies also introduces a degree of unfamiliarity and uncertainty.

  • New Microbiological Methods In Bioprocessing
    New Microbiological Methods In Bioprocessing

    Testing for evidence of microbial contamination in bioprocessing has a long history — and can be expensive, slow, and burdensome. So suppliers, testing facilities, and regulators have been seeking improvements.

  • 4 Steps For Successful Tech Transfer Of Gene And Cell Therapy Products
    4 Steps For Successful Tech Transfer Of Gene And Cell Therapy Products

    As the gene and cell therapy sector develops and its products start to move from development to commercial manufacture — from smaller or academic establishments and development laboratories to larger facilities with greater capacity — the requirement for the technology transfer of these products will only increase.

  • An Analysis Of FDA FY2017 Drug GMP Warning Letters
    An Analysis Of FDA FY2017 Drug GMP Warning Letters

    FY2017 saw another year of increase in the number of drug GMP warning letters issued by the FDA, though not as dramatic a difference as between FY2015 and FY2016. This article presents a detailed summary of those warning letters, as well as a comparison of trends since fiscal year 2013.

  • CRS Files Lawsuit Against FDA
    CRS Files Lawsuit Against FDA

    The watchdog group Center for Responsible Science (CRS), along with clinical trial participants and the father of a deceased trial participant, has filed a lawsuit against the FDA for denial of CRS’ citizen petition, which was originally submitted in June 2014 and has since had several amendments.

  • 5 Keys To Aseptic Processing Improvement & Efficiency
    5 Keys To Aseptic Processing Improvement & Efficiency

    In recent years, we’ve seen a rise in regulatory concern over adequately determining the risk factors that challenge aseptic and sterile products processing. There needs to be a renewed emphasis on assurance and controls, including leveraging the best available technologies and conducting thorough, science-based risk assessments of processes.

  • Commissioner Gottlieb, CAR T-Cells, & The Future Of Rare Disease Therapies
    Commissioner Gottlieb, CAR T-Cells, & The Future Of Rare Disease Therapies

    This article explores some of the policy changes happening now in the regulatory rare disease space as the FDA’s leadership team implements these changes at the agency.

  • Autologous Cell Therapies At Crossroads With FDA: What To Do Now?
    Autologous Cell Therapies At Crossroads With FDA: What To Do Now?

    Regulatory controls on local collection and processing of autologous cells present a major challenge to clinics that want to provide individualized therapies. How can pharma overcome the hurdles?

  • Lessons In Navigating The Complex World Of Orphan Drug Commercialization
    Lessons In Navigating The Complex World Of Orphan Drug Commercialization

    The Orphan Drug Act of 1983 (ODA) has been wildly successful in its primary goal of spurring innovation that has led to lifesaving therapies. Unfortunately, the design of the ODA and several of the incentives the act provides have led to a host of unintended consequences.

  • Cell Therapy: Process Design Considerations To Support Commercialization
    Cell Therapy: Process Design Considerations To Support Commercialization

    Cell therapies have the potential to revolutionize the biopharmaceutical world, but today’s processes, logistics, and delivery make for a challenging entry into the sector’s growth curve. As the industry evolves, we have to answer (at least) three important questions when bringing these exciting new therapies to market.

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