Production Featured Articles

  1. U.S. Pharma Tariffs And MFN Become Law After April 2 Update 4/15/2026

    Beginning July 31, 2026, a U.S. pharmaceutical tariff will apply to patented products and their APIs, beginning with large companies. Beroe Inc.'s Mathini Ilancheran breaks down the tariff's impact, explores its risks, and proposes five procurement strategies to addressing them.

  2. FDA's New Flexible CMC Framework For CGT 4/14/2026

    The FDA is rethinking CMC oversight for cell and gene therapies, prioritizing science‑based justification over rigid validation models. Learn how this lifecycle‑focused approach could reduce burden.

  3. Is Your API Manufacturable — Or Just Technically Feasible? 4/13/2026

    Build manufacturability into your process from the start by evaluating scalability, cost, and cross-functional performance early to ensure consistent, efficient success at every stage of development.

  4. How Patent Expirations Will Reshape The Dry Powder Inhaler (DPI) Market 4/10/2026

    Patent expirations on dry powder inhalers are driving rapid market competition. Discover how optimized mechanical dosing speeds scale-up and protects profit margins.

  5. Part 2: Execution Intelligence: Embedding AI Inside Validated Manufacturing 3/31/2026

    In regulated manufacturing, AI creates value when embedded in validated execution rather than layered above it, tied to batch state, workflow governance, and QA authority.

  6. Video Series: The People Behind The Workcells 3/25/2026

    Learn more about the expertise and decision-making behind dependable workcell performance, offering a closer look at how consistent quality is built, step by step.

  7. 9 Pillars Of Inspection Readiness For GMP Manufacturers: A Practical CSA Playbook 3/25/2026

    Inspection readiness depends on operational systems rather than last-minute preparation. A nine-part framework traces where inspectors look, and where maintenance, calibration, and equipment records carry the most weight.

  8. Why Integrating EAM And QMS Is The Next Step In Digital Quality For Life Sciences: A Practical CSA Playbook 3/24/2026

    Maintenance and quality teams often work from separate systems, leaving gaps in calibration, deviation, and change records. Connecting them in both directions changes how GMP investigations and inspections are handled.

  9. The Evolution Of Parenteral Manufacturing For Sensitive Drugs 3/23/2026

    Parenteral manufacturing is advancing with better facilities, single‑use systems, continuous processing, and Annex 1 compliance to meet demand for specialised biologics and personalised therapies.

  10. Streamline HME Projects With Early Partner Engagement 3/18/2026

    Global partner delivering end‑to‑end drug development, manufacturing, and packaging with deep expertise, advanced facilities, and support across key modalities.