GUEST COLUMNISTS

• FDA's First cGMP Enforcement Action On AI Misuse In Drug Manufacturing

  The warning letter, issued to Purolea Cosmetics Lab, describes a manufacturer that used AI agents to generate drug product specifications and more. Here's why the outsourced pharma industry should take note.

• U.S. Pharma Tariffs And MFN Become Law After April 2 Update

  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.

• How To Implement Post-Approval Changes On A Global Level

  To prepare for inevitable process changes after market authorization, this overview provides critical planning advice for assessing risk and minimizing delays.

• The Business Case For Continuous Manufacturing In Biologics

  The question for leadership is not if continuous manufacturing will transform biologics, but when and how quickly to invest.

• From Principles To Practice: Building Quality Into Generative AI-Assisted Pharma Operations

  Learn what regulators are already asking about AI, what quality must mean in this new context, and how organizations can begin building the governance infrastructure.

• New Research: Co-Expression Could Make Plant-Based Systems Viable

  By co-expressing Protein A with the protein of interest, the work proposes to reduce the abundant cost of chromatography resins with a one-pot purification approach.

• Quantifying Single-Use Waste Produced During mAb Manufacture

  Discover the current scale of plastic single-use technology waste and its projected growth, specifically for the biomanufacturing domain. There is an increasing need for sustainable solutions.