Guest Columns & From The Editor

  1. DEA Reveals Hidden Costs Of Analytical Validation Guidelines 10/2/2026

    By treating distinct validation guidelines as decision-making units, data envelopment analysis (DEA) allows for the mathematical evaluation of their resource efficiency.

  2. What LSPA's Life Sciences Future Says About The Road Ahead For CGT 10/2/2026

    The LSPA’s Life Sciences Future 2026 highlighted how shifting capital, M&A, global competition, and commercial pressures are reshaping CGT.

  3. FDA Modernizes Container Closure Guidance: What Is Changing And Why It Matters 10/1/2026

    The proposed revision reflects changes in packaging technology, drug delivery systems, quality risk management, and more that have occurred since 1999's guidance.

  4. CDMO Selection Beyond Capabilities And Price 9/30/2026

    Some of the most useful information relevant to CDMO selection is also the hardest to obtain. Here are suggestions for uncovering data that tells the whole capability story.

  5. August 2026 — CDMO Opportunities And Threats Report 9/28/2026

    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.

  6. ICH M4Q(R2) And M16 Modernize The CTD For Digital Submissions 9/28/2026

    A former FDA assessor explains how recent changes to the common technical document bring long-overdue updates to the submission process, accounting for greater data demands.

  7. Inside Scaling Next-Gen MSCs Without Scaling Risk 9/25/2026

    Here's why scaling MSC therapies requires maintaining product consistency, potency, and comparability as manufacturing evolves.

  8. Building Sustainable Biopharma Supply Chains Starts With Procurement 9/24/2026

    Nearly all the industry's emissions happen upstream from core manufacturing functions. This puts sustainability almost entirely on the shoulders of purchasing.

  9. Sustainable Facility Design Brings Bayer Instant Savings 9/23/2026

    ROI for sustainability initiatives often come later as lower maintenance and utility costs. Bayer's pursuit of LEED certification led to substantial savings up front.

  10. In Case You Missed Them: Recapping The FDA's Recent Guidances For Cell And Gene Therapies 9/17/2026

    I review 10 of the FDA’s guidances spanning the last 12 months, all of which aid cell and gene therapy companies to assure safety and efficacy of these medicines.