Cell and Gene Regulatory

1. Navigating Tariffs: Implications And Strategies For Pharmaceuticals Manufacturers 4/17/2025

   The U.S. tariffs on trading partners bring a whole new set of challenges, but there are tactics and strategies companies can deploy to help offset the cost and operational impacts. 

2. Accelerate Your Oncology Breakthroughs 4/16/2025

   Finding the right partnership can help your oncology clinical trials overcome trial complexities through strategic planning, a deep scientific understanding, and operational excellence.

3. Ensuring Consistent Removal Of Residual Impurities 4/15/2025

   In this Cell & Gene Live segment, Pratik Jaluria, Ph.D., SVP Technical Development Strategy at BlueRock Therapeutics, Bruno Marques, Ph.D. VP, Process and Product Development at Century Therapeutics, and Kate Rochlin, Ph.D., COO at IN8bio discuss validating impurity removal in allogeneic cell therapies involves collecting extensive data from early research through GMP manufacturing to support regulatory submissions.

4. Assessing Residuals In Processing And Fill/Finish For iPSCs 4/15/2025

   In this segment of Cell & Gene Live, Optimizing Storage Solutions for iPSCs, our expert panelists, Pratik Jaluria, Ph.D., SVP Technical Development Strategy at BlueRock Therapeutics, Bruno Marques, Ph.D. VP, Process and Product Development at Century Therapeutics, and Kate Rochlin, Ph.D., COO at IN8bio explain why detecting and quantifying trace levels of cryoprotectants and excipients in cell therapy products involves a risk-based approach, starting with theoretical worst-case calculations based on formulation concentrations and patient exposure limits.

5. Advancing Rare Disease Clinical Trials: A High-Touch, Patient-Centered Approach For Biotechs 4/15/2025

   On your journey to developing and executing a successful rare disease trial, it is critical to focus on patient experience and accessibility from the earliest stages of trial design.

6. De-Mystifying Regulatory Support During Viral Vector-Based Development 4/15/2025

   Navigating clinical trials for viral vector-based cell and gene therapies demands specialized expertise and regulatory insight. Learn how scientific acumen and strategic planning bring innovative therapies from lab to patient.

7. Ramping Up GMP-Compliant CAR-NK Manufacturing At Scale With iPSCs 4/15/2025

   The ability to produce billions of NK cells in a single production run represents a transformative shift in the economics and logistics of cell therapy.

8. Control Strategies And Method Development For Nitrosamines In APIs And Drug Products 4/15/2025

   Explore regulatory insights, analytical strategies, and real-world case studies for effective nitrosamine control in APIs and drug products.

9. From Tissue Donation To Distribution: Understanding EU Regulatory Requirements In Cell Therapy Clinical Trials 4/14/2025

   Understanding how the European Union's Directive 2004/23/EC interacts with GMP — and where its jurisdiction begins and ends — is essential for successful clinical trial planning, compliance, and execution.

10. Clinical Trial Regulations 4/11/2025

    Explore this essential guide for mastering the complex landscape of clinical trial regulations, providing a clear, practical breakdown of regulatory timelines, submission procedures via the CTIS, and the legal obligations for both EU and non-EU sponsors.