Cell and Gene Outsourcing

  1. December 2025 — CDMO Opportunities And Threats Report 1/20/2026

    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. The Science Of Collaboration: Building Smarter Cell Therapy Partnership 1/20/2026

    Successful cell therapy programs rely on evolving, science‑driven partnerships that integrate CMC strategy, deepen rigor over time, and translate complex research into scalable, compliant, clinically ready processes.

  3. Built‑In Quality For Audit‑Ready Manufacturing 1/20/2026

    Pre‑approval inspection readiness requires embedding quality, traceability, contamination control, and robust analytical and documentation practices into everyday cell therapy manufacturing to prevent delays and ensure regulatory confidence.

  4. Balancing Speed And Regulation In Cell Therapy 1/20/2026

    Rapid cell therapy development demands early planning for scalability, standardized platforms, and inspection‑ready operations to meet rising regulatory expectations and avoid costly rework in later clinical phases.

  5. Designing Cell Therapy Analytical Programs For Regulatory Success 1/20/2026

    Expedited cell therapy pathways demand early, reliable analytical development to ensure robust data, regulatory confidence, and smooth transitions from discovery through clinical stages without costly delays.

  6. New Standards For Elastomeric Components In Sterile Packaging 1/20/2026

    USP’s new elastomeric packaging standards shift testing to full system‑level evaluation, strengthen integrity and usability expectations, and place compliance responsibility on drug developers.

  7. Modern Lentiviral Platforms For Scalable Cell Therapy 1/20/2026

    A new platform approach streamlines lentiviral vector design and manufacturing, boosting yield, lowering costs, and accelerating access to gene‑modified cell therapies worldwide.

  8. Small Scale Proof. Large Scale Confidence. 1/16/2026

    Proof of concept studies with a proven path to manufacturing success.

  9. Sterile Injectables: Why Innovation Matters More Than Ever 1/15/2026

    New technologies and regulatory changes are shaping safer, more efficient filling processes. Discover why innovation is key to protecting patients and advancing therapies.

  10. Choosing The Right CDMO Partner In Biopharma 1/15/2026

    Selecting a CDMO is a high-stakes strategic decision impacting quality, timelines, and regulatory success. The right partner offers integrated capabilities, scientific expertise, agility, transparency, innovation, and shared purpose.