Clinical Supply Manufacturing Articles

  1. On The Potency Assurance Journey, Travelers Need A Road Map 11/13/2025

    When regulatory expectations change by the phase, the route can be difficult and confusing to navigate for both new and experienced potency investigators.

  2. The Potential Impact Of U.S. Tariffs On The Biotech Sector: Manufacturing, Funding, And Clinical Trials 5/12/2025

    Syner-G Biopharma Group's Raymond Forslund, Ph.D., MBA explores how U.S. tariffs might affect biotech manufacturing, funding, and clinical research.

  3. A Multi-Omics Approach For Characterizing Clinical-Scale iPSC Batches 11/6/2025

    The transition from 2D to 3D cell culture requires a combination of advanced analytical techniques, but aligning new methods with established principles can be challenging.

  4. Designing Highly Agile Bio/Pharma Manufacturing Facilities 4/5/2024

    In bio/pharma, agile manufacturing is achieved through multipurpose designs that support a variety of unit operations manipulated and operated as independent yet connected modules. 

  5. Multiplying Forces Of Clinical Supply Outsourcing 1/30/2023

    There are a number of varying and converging forces baring down on sponsors looking for CROs/CDMOs who can provide a full slate of services around their clinical-trial material. Both CDMOs and sponsors need to add or subtract from their strategies to adjust.

  6. The 4 Technologies Poised To Transform The Pharmaceutical Supply Chain In 2025 And Beyond 12/2/2024

    These key technological advancements will significantly impact the pharma/biotech supply chain in 2025 and beyond. If you aren't implementing any of them yet, you may want to rethink your plans.

  7. Solving The Leukopak Supply Chain Issue With Cryopreservation 11/25/2024

    Allogeneic cell therapy developers report an alarming number of starting materials arrive at the wrong temperatures, late, or fail to arrive altogether.

  8. 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.

  9. AstraZeneca's Digitally Connected Strategy For API Manufacturing 12/3/2024

    The company's packing in the latest technology at its APICOM facility in Dublin. A key feature is more effective and timely use of process data.

  10. 7 Steps To Accelerate Biopharma Manufacturing Processes 5/21/2024

    Now more than ever, manufacturing capability can make or break success. To navigate the challenges, small biopharma companies must adopt these strategic approaches.