Industry Insights

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. 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.

7. 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.

8. 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.

9. 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.

10. 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.