Featured Insights

  1. Sterility Assurance With Louise Ui Fhatharta 1/17/2025

    This discussion explores critical aspects of maintaining sterility in pharmaceutical manufacturing, from facility design and environmental monitoring to regulatory compliance and common misconceptions.

  2. Unraveling The Complexity Of Cell Therapy: Advancements And Challenges 11/26/2024

    Cell therapy has emerged as a powerful tool for addressing critical medical challenges, but its rapid evolution necessitates a clear regulatory framework and consistent terminology.

  3. Strategic Management Of The Mature Product Portfolio 4/7/2024

    Explore a new outsourcing paradigm that integrates expertise, regulatory knowledge, efficiency, and cost containment, moving beyond traditional low-cost offshore staffing models.

  4. Partnering With Health Systems: Essential Tips For CGT Commercialization 12/5/2025

    Successful cell and gene therapy commercialization requires early, detailed manufacturer collaboration with health systems to ensure scalable operations and seamless patient access beyond the clinical trial.

  5. Navigating The CGT Supply Chain: Key Logistical Challenges And Solutions 7/16/2025

    Commercializing cell and gene therapies requires overcoming complex logistical hurdles. Customized strategies for temperature control, compliance, and end-to-end delivery are crucial to prevent supply chain issues.

  6. A Year Of Reflection And Preparation 1/3/2025

    The Trial Master File (TMF) landscape in 2025 will require companies to stay attuned to the evolving ICH E6(R3) guidelines and the full implementation of the CTIS.

  7. Navigating The Complex Regulatory World Of ATMPs/CGTs 1/15/2026

    Discover how shifting definitions for ATMPs and CGTs impact global development strategies, from CMC validation requirements to navigating the latest European pharmaceutical legislation and expedited regulatory pathways.

  8. Navigating The Cell And Gene Regulatory Landscape 10/3/2024

    Navigating the complex regulatory landscape is essential for cell and gene therapy success. Explore key considerations, challenges, and best practices for companies operating in this space.

  9. Evolving And Expanding Global Consulting With Local Expertise 2/3/2025

    Experts discuss global market expansion, emphasizing regulatory complexities, product lifecycle investments, and integrating local expertise to ensure successful product launches and long-term market sustainability.

  10. The Need For Adaptive Distribution Partners For Cell And Gene Therapies 1/6/2026

    Optimize your commercial strategy by exploring how adaptive distribution models navigate reimbursement challenges and improve patient access. Partner early to align workflows and ensure operational success.