Guest Columns

  1. June 2026 — CDMO Opportunities And Threats Report 7/30/2026

    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 Decision Rights Matrix: Making Sponsor-CDMO Governance Enforceable 7/29/2026

    In LVV manufacturing, the quality target product profile and the DRM are designed to work together. One defines what is being governed, the other names who governs it.

  3. Defining Quality In A Sponsor-Owned QTPP Before The CDMO Even Starts 7/29/2026

    Version-controlled quality target product profiles, authored by the drug sponsor, close any gaps between the CDMO's and sponsor's definitions of quality.

  4. Demonstrating Non-Inferiority Of BFPCs Vs. Traditional Air Monitoring 7/22/2026

    Demonstrating non-inferiority of bio-fluorescent particle counter (BFPC) technology to traditional active air-sampling methods is essential for implementation. Here's how to approach it.

  5. Let's Stop Treating Allogeneic Cell Therapy As One Thing 7/14/2026

    Industry is beginning to accept that allogeneic cell therapy spans categories, and success depends on aligning biology, regulation, and economics unique to each product.

  6. Allogeneic Cell Therapy Is Still Learning What Biology Will Allow 7/14/2026

    Allogeneic cell therapy is advancing through smarter donor selection and manufacturing control, showing how biology, process design, and product consistency drive success.

  7. Building CGT Manufacturing Capacity For The Next Commercial Era 7/13/2026

    Recent investments — mostly by CDMOs — are expanding manufacturing capacity to support the growing cell and gene therapy pipeline. We also discuss associated trends and impacts.

  8. Top 5 Challenges In Antibody-Oligonucleotide Manufacturing 7/10/2026

    AOC manufacturing breaks programs in five predictable ways. Learn where antibody-oligonucleotide conjugate development stalls, from synthesis impurities to conjugation chemistry, and what preparation actually looks like.

  9. Managing The Presence Of Visible Particulates In Cell Therapies 7/10/2026

    Here's a holistic approach to developing a comprehensive particulate control strategy for cell therapies, focusing on particle characterization, detection, and manufacturing controls. 

  10. Analyzing And Managing CDMO Project Risks Using Causal Mechanism & Effect Analysis 7/8/2026

    Since every sponsor–CDMO relationship can have widely different scopes, requirements, and procedures, this article focuses on the basic principles for analyzing and managing the risks of not achieving the relationship’s objectives.