Cell and Gene Regulatory

  1. A Shift Towards Biofluorescent Particle Counters In Manufacturing 5/12/2025

    Sterility in injectable drug manufacturing is vital for patient safety and efficiency. Discover how biofluorescent particle counters revolutionize contamination control, regulatory compliance, and operational excellence in modern pharma.

  2. Achieving Regulatory Compliance With A Unified Immunogenicity Strategy 5/10/2025

    This presentation equips viewers with the knowledge and tools needed to navigate the intricacies of designing immunogenicity assays that comply with both European IVDR and US FDA regulations.

  3. A Case For Paying Allogeneic Cell Therapy Product Donors 5/9/2025

    The debate over whether to pay donors for cell therapy starting materials comes down to four areas of disagreement: altruism, availability, ethics, and safety.

  4. The Flexibility Of Reconsent In Clinical Trials 5/9/2025

    Explore the common misconceptions surrounding reconsent, as well as the reality of its ability to be a flexible, ethics-driven communication practice grounded in respect for participant autonomy.

  5. Excipient GMP: Elevating Standards In Cell Culture Solutions 5/8/2025

    The quality of non-active ingredients, or excipients, directly impacts product safety and efficacy. Learn why Excipient GMP is vital for cell culture solutions and how it elevates manufacturing standards.

  6. The EU Biotech Act Has Been Delayed — Here's What That Means 5/7/2025

    First due at the end of 2025, the act has been delayed until late 2026, which suggests key issues that many say hobble innovation will go unaddressed for longer.

  7. From Preparation To Compliance: DSCSA Implementation Takes Big Steps In 2025 5/7/2025

    The phased exemption periods of the Drug Supply Chain Security Act (DSCSA) expire on different dates throughout 2025 (including one quickly approaching in May), marking a series of milestones for implementation.

  8. Addressing Human "Error" In Pharma Manufacturing 5/7/2025

    Why is it that managers at pharma manufacturing sites continue to be frustrated by what could be labeled as “avoidable” human errors, and what can companies do about it? Let's investigate.

  9. Redefining Heart Failure Treatment with Precision Autologous Cell Therapy with BioCardia's Peter Altman, Ph.D. 5/6/2025

    In this episode of Cell & Gene: The Podcast, Host Erin Harris sits down with Peter Altman, Ph.D., CEO of BioCardia, to discuss the company’s evolution from a cardiac biotherapeutic delivery firm to a developer of autologous and allogeneic cell therapies for cardiovascular and pulmonary diseases.

  10. Compliance With Annex 1- Sterile Fill Finish 5/5/2025

    Eurofins ensures Annex 1 compliance through robotic isolators, PUPSIT, contamination control strategies, and rigorous training for aseptic sterile fill-finish of early-phase clinical products.