Cell and Gene Regulatory

  1. Mitigate Clinical Risk In Cell Therapy Development With A GMP Compliant Process 4/21/2025

    Help shape the future of medicine by building better, safer cell therapies. See how expertise in scalable, GMP-compliant cell engineering can effectively mitigate clinical development risks.

  2. Innovating Unmet Needs For Next-Generation Cellular Immunotherapies 4/21/2025

    Advancing cellular immunotherapies requires overcoming key hurdles. Explore innovative technology addressing unmet needs in safety, efficiency, cost, and capacity for next-generation treatments.

  3. Adopting Isolators To Overcome Aseptic Challenges With ATMP Processing 4/21/2025

    Gain insight into how Isolators enhance ATMP production by providing superior control and protection to ensure compliance with GMP regulations and to reduce cleanroom costs.

  4. 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. 

  5. Accelerating Clinical Data Review With Traceable Workflows 4/17/2025

    Discover how streamlined workflows and enhanced collaboration between data managers and medical reviewers can boost clinical trial efficiency, improve data quality, and ensure patient safety.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.