Cell and Gene Regulatory

  1. Gene Therapy In-Use And Device Compatibility Studies 7/28/2025

    Discover an essential aspect of development that ensures gene therapy products remain safe, stable, and effective throughout preparation and administration by simulating real-world clinical conditions.

  2. Innovation That Is Evolving The CGT Landscape In 2025 7/28/2025

    Uncover how cell and gene therapy leaders are adapting to funding pressures, regulatory shifts, and global complexity by prioritizing scalability and strategic partnerships for long-term success.

  3. The 3 FDA Oncology Approvals That Will Have The Biggest Impact In 2025 7/25/2025

    The FDA wrapped up 2024 with 3 notable approvals. Harpreet Singh, MD and CMO, provides a recap.

  4. The FDA's New Guidance May Be Shaking Up Biotech 7/25/2025

    The FDA’s recent draft guidance on accelerated approval outlines tougher standards for confirmatory trials and introduces a faster process for withdrawing approvals.

  5. Next Generation Sequencing In Viral Safety Testing 7/25/2025

    Next Generation Sequencing (NGS) offers a sensitive, high-throughput solution for detecting adventitious viral agents (AVAs), improving biopharmaceutical safety and accelerating regulatory-compliant product development.

  6. Designing "Seamless Phase 1/2" Oncology Trials 7/25/2025

    Selecting a CRO with deep oncology expertise and seamless trial experience is vital to navigate these complexities and deliver transformative therapies to patients faster.

  7. Optimizing Contamination Control: Strategy Planning And Execution For Facility Compliance 7/25/2025

    A robust contamination control strategy using a plan-do-study-act framework ensures compliance, product quality, and operational efficiency in biopharmaceutical manufacturing facilities.

  8. Maximizing Results For Viral Clearance Studies 7/25/2025

    Explore virus strain selection and titer strategies to optimize viral clearance studies, covering regulatory expectations, study design, and execution best practices.

  9. Can Your Facility Cleaning, Environmental Monitoring, And Disinfection Process Pass Regulatory Scrutiny? 7/25/2025

    Explore facility cleaning, monitoring, and disinfection strategies to meet regulatory standards, emphasizing planning, stakeholder involvement, testing, trending, documentation, and continuous improvement.

     

  10. 5 Best Practices For Improving AI Literacy In A GxP Environment 7/25/2025

    ERA Sciences' Ben O'Brien shares five tips to improve pharma and biotech companies' AI literacy when operating in a GxP environment.