Industry Insights

  1. Risk-Based Analytical Method Selection In Cleaning Validation Using ASTM International Standards 10/14/2025

    This in-depth article describes risk in cleaning and provides a science- and risk-based framework for selecting analytical methods using ASTM International standards.

  2. Application Of CRISPR Technology In iPSC Gene Correction 10/14/2025

    The CRISPR-iPSC combination is becoming a core tool for precision medicine with advanced editing efficiency, differentiation control, and safety profiles.

  3. Understanding CLL And SLL Treatment Evolution 10/10/2025

    Tevogen Bio's Dr. Neal Flomenberg and Dr. Dolores Grosso discuss the shift from chemotherapy to targeted therapies such as Jaypirca and highlight Tevogen’s antigen-specific T cell platform as a new frontier in cancer and infectious disease treatment.

  4. What Can The Tech Sector's 'Minimally Viable' Concept Teach Biopharma? 10/9/2025

    Deciding what is good enough to get started can support the mindset of building something without sacrificing quality, functionality, or safety.

  5. Cell & Gene Therapy Outsourcing's New Paradigm 10/7/2025

    The industry has flipped from scarcity to surplus, and sponsors now have leverage to set terms, not take numbers.

  6. Survey: 30% Of Biopharmas Cite Cost, Productivity As Top Priorities 10/6/2025

    Both focus areas aim at the same outcome, stronger economics and sustainable competitiveness, according to BioPlan Associates' 22nd Annual Biomanufacturing Report.

  7. Bringing CGT Home: Equipping Community Hospitals For The Next Frontier 10/6/2025

    Decentralizing CGTs to community hospitals presents a crucial opportunity to improve patient access by reducing travel burdens, but requires overcoming significant challenges such as building specialized clinical infrastructure, coordinating complex care pathways, ensuring data interoperability, and more.

  8. Import Product Specifications And Drug Registration Testing For China 10/6/2025

    This overview and its recommendations are valid for drug registration testing (for marketing authorization application in China) as well as import testing (for commercial batches to be imported to China after approval).

  9. Navigating Regulatory Frameworks For Allogeneic CAR-NK Control Strategies 10/3/2025

    The regulatory landscape for this emerging modality is vast and tortuous. One regulatory CMC expert, a former FDA reviewer, helps us with a path through it all.

  10. Advancing Telomere Targeting Therapy For Non-Small Cell Lung Cancer 10/3/2025

    MAIA Biotechnology's Dr. Vlad Vitoc shares insights into how the company is advancing a novel therapeutic strategy that could redefine the treatment landscape for hard-to-treat cancers.