Outsourced Pharma Editorial

  1. 4 Facility Considerations for API Manufacturing 4/6/2026

    Success depends not only on equipment and infrastructure, but also on specialized workforce training, rigorous quality control, robust data management, and increasingly sophisticated supply chain and manufacturing technologies.

  2. From Principles To Practice: Building Quality Into Generative AI-Assisted Pharma Operations 4/6/2026

    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.

  3. Quantifying Single-Use Waste Produced During mAb Manufacture 4/2/2026

    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.

  4. From QM To QMM For AI-Assisted Pharmaceutical Manufacturing Operations 4/1/2026

    The FDA’s focus has shifted from tracking quality metrics to promoting quality management maturity. AI/ML is poised to help with efforts, though it introduces additional complexity around data integrity.

  5. The Systems And Choreography Needed For Grade B ATMP Material Transfer 3/31/2026

    Traditional material air locks often fail to account for the sheer throughput needed for cell therapy workflows. These design tips help prevent traffic jams.

  6. Does Biotech Need More Government Funding — Or A New Business Model? 3/30/2026

    Should government financing appreciably recede – whether through policy shifts, budget pressures, or ideological bent – what would happen to the biotech business model? To ascertain such a question, first we must look at the fundamentals of the existing model, and then understand investors (and service providers) better.

  7. Rethinking ATMP Assurance When Sterility Timelines, Reality Misalign 3/27/2026

    The compendial 14-day sterility testing window exposes product and patient to numerous risks, but settling on a rapid alternative also presents its own set of challenges.

  8. Immobilized Enzymes Promise Alternative To Cyanogen Bromide's Toxicity 3/27/2026

    Proteases may be more expensive up front, but the benefits of cutting out a highly toxic substance quickly add up when disposal and environmental safety costs go down.

  9. Navigating GMP Biosafety Challenges In ATMP Manufacturing 3/26/2026

    BioPhorum's survey findings reveal a wide variation in how biosafety is managed within GMP environments for viral-based ATMPs, underscoring the need for harmonized guidance.

  10. What If The U.S. Government Stopped Funding Biotech? 3/23/2026

    It sets off a real tension – ideological, economic, even personal. But what would happen if the U.S. government cut direct financial support for “biotechnology research,” leaving it entirely to investors, private and public markets, and bigger pharma? "Our industry’s mind-meld says with no government largesse our biotech industry collapses," writes Chief Editor Louis Garguilo. It's an "outlandish hypothetical," but he asks for a few minutes to go through this. And he has help in making his case.