Guest Columns

  1. September 2025 — CDMO Opportunities And Threats Report 10/14/2025

    Each month, Outsourced Pharma works in conjunction with PharmSource, part of GlobalData, to present its “Contract Manufacturing: Opportunities and Threats (CMOT) Report” to our readers. The report identifies CDMOs that might be impacted by key events affecting their clients, including company acquisitions, product acquisitions and licenses, product approvals, late clinical product terminations, and FDA rejections.

  2. Should We Refocus On The Product, Then Engineer The Process? 10/14/2025

    Logic behind the "process is the product" refrain collapses when you accept that starting material is non-uniform by design. These experts want to rethink a tired cliche.

  3. CRISPR And iPSC Disease Modeling And Drug Screening 10/14/2025

    iPSCs combined with the CRISPR-Cas9 gene editing system can construct or repair mutations and establish highly accurate, controllable in vitro models.

  4. 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.

  5. 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.

  6. 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.

  7. 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. 

  8. 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.

  9. 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).

  10. 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.