Clinical Supply Manufacturing Articles

  1. Process Validation: Working Toward Harmonization Of Terms Used To Identify Validation Lots 10/31/2025

    The terms “confirmatory" and "conformance" batches are inconsistently used in the industry. Since process validation is essential for maintaining compliance and detecting variability, we must work toward harmonization of the terms to avoid confusion.

  2. The Real Cost Of Poor Quality — And What You Should Do About It 7/30/2024

    It is well recognized that poor quality can lead to supply disruption. To drive positive change, the sector should seek to greater enhance quality maturity.

  3. 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.

  4. The Holistic Guide To Supply Chain For Cell & Gene Therapy Startups 1/19/2023

    How does the cell and gene therapy supply chain team stay ahead of the expected changes and respond at the speed the developing program expects? Supplier selection, raw materials, built-in quality, warehousing and logistics, and traceability are all covered in this article.

  5. 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. 

  6. Beware The Manufacturing Bottleneck: Lessons From Inside 6/6/2022

    Steven Kelly, President & CEO, Carisma, a biotech with a CAR M therapy in phase one, is a repeat-CEO. “I’ve had a varied experience, and different functional responsibilities,” he says, "but when I think about manufacturing, two experiences stand out for me.” 

  7. NK Cell Therapies: How Artiva Biotherapeutics Leverages Its "Manufacturing First" Approach 4/24/2024

    We caught up with Chris Horan, Artiva Biotherapeutics' CTO, to discuss natural killer cell therapies and Artiva’s experiences and strategies with its candidate, AlloNK.

  8. Quick Takes From Takeda Austria's Annex 1 Rollout 3/25/2024

    At ISPE's 2024 Aseptic Conference, Takeda Austria's site head spoke about lessons learned from Annex 1 implementation. We caught up with her and asked for the highlights.

  9. 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.

  10. 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.