Editors' Desk

  1. 4 Ways To Building A Better CMC Tech Transfer 9/23/2026

    A technology transfer can falter long before a process reaches the plant. Gaps in process knowledge, mismatched equipment, and insufficient scale-up data can all undermine reproducibility, timelines, and cost.

  2. AI Governance Is Just Like Driving A Race Car 9/1/2026

    Though some skeptics remain, nearly every business is at some stage of AI adoption. The technology has proven applications in pharmaceutical manufacturing, but effective governance must keep pace with its rapid development. That challenge is familiar to Bill Reid, healthcare and life sciences lead in Google’s Chief Information Security Office (CISO).

  3. Can U.S. Policy Bring Generic Drug Manufacturing Back Home? 8/25/2026

    Generic medicines imported into the U.S. were not subject to the recently imposed tariffs on imported pharmaceuticals, but President Trump posted in July that this could change within two years.

  4. AI Needs Human Oversight To Better GMP Documentation 8/12/2026

    In a Pharmaceutical Online Live discussion on building inspection-ready systems with digital documentation, panelists emphasized that AI can accelerate review, trend analysis, and inspection response, but only when governed, validated, and kept firmly under human quality oversight.

  5. 6 Reasons Pharma Manufacturing Has Eyes On Puerto Rico 8/1/2026

    Several advantages explain why Puerto Rico continues to attract pharma investment, especially as manufacturers reassess supply chain risk and look for options closer to the U.S. mainland.

  6. Building AI Readiness Through Cross Collaboration 7/22/2026

    AbbVie’s Operations Quality Assurance Innovation Accelerator offers a practical model for moving from AI enthusiasm to governed, people-centered execution.

  7. Bayer Adds A Spine To Modularity For Scale Without Disruption 7/16/2026

    Modular facility concepts offer a different path, giving manufacturers the ability to expand capacity stepwise, standardize core infrastructure, and adapt production environments as product portfolios evolve

  8. 7 Facilities Pilot PreCheck for Faster Approval 7/13/2026

    A more streamlined path to operational new pharmaceutical facilities in the U.S. may be on the horizon. Nearly a year after the PreCheck Pilot Program was introduced by the U.S. Food and Drug Administration (FDA) in August 2025, the first seven participating facilities have been announced.

  9. Inside Chugai's Digital Infrastructure Strategy 6/29/2026

    When a facility is fully automated and designed for manufacturing flexibility, it needs a digital infrastructure that pulls the systems together, reports data accurately and efficiently, and recognizes areas for continuous improvement.

  10. [VIDEO] GLP-1 Manufacturing's New Bottlenecks At Multi-Ton Scale 6/24/2026

    “At multi-ton scale, the challenge becomes less about making the molecule and more about controlling the variability of the process in this interconnected system,” explained Villain.