INSIGHTS ON CELL & GENE REGULATORY ISSUES

  • Planning Is Everything - Quality Control Testing In Cell And Gene Therapy
    Planning Is Everything - Quality Control Testing In Cell And Gene Therapy

    Compliance with quality control (QC) standards is a basic requirement for products manufactured under good manufacturing practices (GMP) conditions. In this post we will explore the main compendial QC tests that ensure cell and gene therapies are safe for use in patients, and important considerations for integrating QC testing into the manufacturing process.

  • Automating Cell Therapy Manufacturing For Increased GMP Compliance And Consistency
    Automating Cell Therapy Manufacturing For Increased GMP Compliance And Consistency

    Exploring the use of automation in cell therapy and advanced therapeutic medicinal product manufacturing to improve safety, quality, and compliance is a key factor in advancing patient care.

  • FDA FY2018 Human Tissue And Cell Therapy Observations And Trends
    FDA FY2018 Human Tissue And Cell Therapy Observations And Trends

    This article presents the most recent publication of GMP Human Tissue for Transplantation Form 483 observation data from the FDA. We examine data from FY2018 and evaluate a total of four years’ worth of trends in GMP inspection enforcement in this area.

  • MES – The Data Integrity Engine On The Shop Floor
    MES – The Data Integrity Engine On The Shop Floor

    In the last years, the FDA has seen an increase in data integrity violations. Read how using an MES will boost your data integrity compliance and your process understanding, since your processes will be well structured, executed, maintained and documented across the pharmaceutical product life cycle.

  • Regulatory Oversight On Gene Therapy In The U.S. And EU
    Regulatory Oversight On Gene Therapy In The U.S. And EU

    Decades of painstaking research have recently begun to yield gene therapy products that are delivering meaningful benefits to human health. With the rapid evolution of the gene therapy field, regulatory agencies have been working to keep pace with these scientific and clinical breakthroughs. An understanding of the regulations and guidance documents reflecting regulator current thinking surrounding gene therapies is essential to success.

  • Rare Disease: Operationalizing Gene Therapy Trials
    Rare Disease: Operationalizing Gene Therapy Trials

    Even measured against the vast scientific mystery that defines the biotech industry, gene therapy poses extraordinary challenges. This paper explores the history of gene therapy trials, as well as the types of gene therapy vectors and delivery strategies. Also discussed is the regulatory and operational challenges associated with gene therapy trials, including start-up regulations, site selection, recruitment, and retention.

  • How To Speed Up Cell And Gene Therapy Treatments For Patients, Reduce The Number Of Manual Operations And Eliminate Operator Errors
    How To Speed Up Cell And Gene Therapy Treatments For Patients, Reduce The Number Of Manual Operations And Eliminate Operator Errors

    This white paper addresses the unique production problems of cell and gene therapy and explains how a manufacturing execution system (MES) can address them. It provides guidance on how to select an MES and a case study of two CAR-T therapy companies scaling up with and without an MES.

  • Developing A New Biologic Drug: Regulatory Challenges And Considerations
    Developing A New Biologic Drug: Regulatory Challenges And Considerations

    The journey from research lab to market is a long one, and most drug candidates do not make it. For those that do progress to market, there are many regulatory milestones and hurdles. Following are some tips to assist with up-front planning to prevent headaches down the road.

  • FDA Rapid Inquiry Program Takes Aim At Regenerative Medicine Compliance
    FDA Rapid Inquiry Program Takes Aim At Regenerative Medicine Compliance

    Regenerative medicine holds promise, though evidence to back claims about current therapies is underwhelming. The FDA's announcement of the Tissue Reference Group Rapid Inquiry Program returns our attention to the administration's regenerative medicine policy framework.

  • Developing And Manufacturing Cell & Gene Therapies: Do Biopharma Methods Apply?
    Developing And Manufacturing Cell & Gene Therapies: Do Biopharma Methods Apply?

    Are the methods used for developing the current generation of biopharmaceuticals, monoclonal antibodies, hormone replacements, etc., applicable to the next generation of Cellular and gene therapies?

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