Cell and Gene Regulatory

1. Inside Kyverna's Autoimmune CAR T Platform Beyond SPS 9/16/2026

   Kyverna's progress suggests that autoimmune CAR T's commercial viability will depend as much on manufacturing readiness and focused indication selection as on its potential to deliver durable, drug-free remission.

2. New USP Guidelines, Standards Address Lentivirus Characterization 9/16/2026

   The United States Pharmacopeia is rolling out new standards and tools to help manufacturers characterize fragile, complex lentiviral vectors.

3. GLP-1 Peptides Around The World Part III: EU Evolution – Expanded Expectations And Emerging Enforcement 9/15/2026

   Navigating GLP-1 development in Europe? Discover how stricter CMC, Annex 1, serialization, and supply chain requirements are influencing manufacturing strategies.

4. Making Complex Science Dependable 9/15/2026

   Advance small molecule programs with the right mix of scientific expertise, scalable manufacturing, regulatory readiness, and analytical support from discovery to launch.

5. De-Risking Cell Culture Media Scale-Up For Late-Stage Manufacturing 9/11/2026

   Explore practical approaches to scaling cell culture media manufacturing, from supply assurance to evolving quality requirements, digital formulation tools, and strategies for controlling costs.

6. Pharmacovigilance Is Not A Checkbox: Rethinking Safety Monitoring From Day One 9/10/2026

   Cell and gene therapies demand a pharmacovigilance approach built from the ground up, not adapted from frameworks designed for conventional drug products.

7. Beyond Breakdowns: Building A Culture Of Proactive Maintenance 9/8/2026

   Reactive maintenance can drive costly downtime, deviations, and reliability challenges. Learn how proactive maintenance strategies help improve equipment uptime and strengthen compliance.

8. Focusing On Quality Unit Independence With Tatyana Matveeva, Ph.D. 9/8/2026

   In this episode of “Better Biopharma,” host Tyler Menichiello is joined by Tatyana Matveeva, Ph.D., an expert in cGMP manufacturing and regulatory compliance.

9. Accelerating CAR T-Cell Therapy Manufacturing For Autoimmune Disease 9/7/2026

   Proactive alignment and integrated quality systems can shorten cell therapy timelines. Rapid tech transfer and in-house analytics support regulatory rigor and reduce scaling risks.

10. Breaking The Limits Of Automated Sample Preparation 9/2/2026

    Automated nucleic acid purification can deliver high throughput without limiting flexibility or consuming valuable bench space. See how adaptable workflows support efficient sample preparation.