Featured Outsourcing Editorial

  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. 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.

  4. Fermentation Of Live Biotherapeutic Products In cGMP Environments 10/8/2025

    We follow the journey from master cell bank to large-scale anaerobic fermentation, highlighting the unique needs for working with oxygen-sensitive, strictly anaerobic therapeutic microbes in a cGMP setting. 

  5. 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.

  6. 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).

  7. 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.

  8. What If We Had Just One Developability Parameter? 10/3/2025

    Research suggests years-long stability studies that gobble up material can be reduced to a single day using milligram quantities.

  9. Trust But Verify: Validating AI In Pharma's GxP World 10/3/2025

    Here are practical tips to build validated, transparent, and auditable AI systems that align with GxP principles, paving the way for smarter and more resilient manufacturing processes.

  10. What You Should Know About USP's Bioassay Updates 10/2/2025

    The United States Pharmacopeia is overhauling general chapters to align them with current industry standards. One scientist on the project helps us unpack the changes.