Cell and Gene Regulatory

51. Prioritizing Quality, Fit, And Supplier Reliability In CGT Materials 4/1/2026

    In this segment of Cell & Gene Live, "Materials Matter: Ensuring Quality of CGT Materials," Anthony Blaszczyk, Ph.D., Senior Scientist at the U.S. Pharmacopeia, and Basak Clements, Ph.D., Founder and Senior Advisor at biomatria, were joined by Cell & Gene Chief Editor Erin Harris to discuss why companies should prioritize technical fit, quality, and supply chain reliability when selecting materials in cell and gene therapy.

52. Bridging Analytical Gaps To Ensure CGT Material Quality 4/1/2026

    In this segment of Cell & Gene Live, "Materials Matter: Ensuring Quality of CGT Materials," Cell & Gene Chief Editor Erin Harris was joined by Anthony Blaszczyk, Ph.D., Senior Scientist at the U.S. Pharmacopeia, and Basak Clements, Ph.D., Founder and Senior Advisor at biomatria, to discuss why analytical gaps remain a major challenge in cell and gene therapy.

53. Making USP Guidance Actionable For CGT Materials 4/1/2026

    In this segment of Cell & Gene Live, Anthony Blaszczyk, Ph.D., Senior Scientist at the U.S. Pharmacopeia, and Basak Clements, Ph.D., Founder and Senior Advisor at biomatria, were joined by Cell & Gene Chief Editor Erin Harris to discuss USP’s Cell & Gene Therapy Expert Committee, which is working to make existing guidance, such as USP 1043, more practical and actionable, while developing updated frameworks that clarify roles across the supply chain and strengthen risk-based control of raw materials.

54. Inside The Phased, Risk-Based Approach For CGT Materials 4/1/2026

    In this segment of Cell & Gene Live, Anthony Blaszczyk, Ph.D., Senior Scientist at the U.S. Pharmacopeia, and Basak Clements, Ph.D., Founder and Senior Advisor at biomatria, were joined by Cell & Gene Chief Editor Erin Harris to discuss the efforts that are underway to close the gap in particulate guidance for cell and gene therapy by developing new best practices and fostering cross-industry collaboration, recognizing that particulates remain a complex, unsolved challenge.

55. FDA's Plausible Mechanism Pathway For Personalized Gene Therapies 3/31/2026

    As personalized gene therapies emerge, FDA’s plausible‑mechanism pathway offers a faster route to approval. Learn how this new framework could reshape development strategies and accelerate breakthrough therapies.

56. Navigating FDA's CMC Expectations For Cell And Gene Therapy 3/31/2026

    As FDA updates CMC expectations for cell and gene therapies, developers must address critical quality, consistency, and safety requirements. Learn how strategic manufacturing choices can speed and strengthen development.

57. Unlocking CAR‑T Success With Essential FDA Guidance Insights 3/31/2026

    CAR‑T therapies promise breakthrough impact but come with tough clinical and regulatory demands. Get the key FDA guidance sponsors need to navigate complexity and accelerate these transformative programs.

58. Equipment Service Solutions 3/31/2026

    Take a look at how proactive service planning, preventive maintenance, and digital support can help reduce downtime, simplify compliance, and keep manufacturing equipment performing reliably.

59. Building Bulletproof Bioprocesses With Equipment Qualification 3/31/2026

    Consistent equipment performance is critical for compliant biomanufacturing. Learn how lifecycle‑based, risk‑driven qualification strategies can reduce risk and improve efficiency.

60. Qualification And Requalification Services 3/31/2026

    Equipment changes, maintenance, and regulatory updates can quietly put compliance at risk. Learn how a lifecycle-based approach to qualification helps maintain performance and inspection readiness.