GUEST COLUMNISTS

• 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.

• From QM To QMM For AI-Assisted Pharmaceutical Manufacturing Operations

  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.

• Immobilized Enzymes Promise Alternative To Cyanogen Bromide's Toxicity

  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.

• Ever Wonder What Running A $50B Capital Facilities Project Feels Like?

  Eli Lilly and Company's projects in the U.S. include greenfield sites where little infrastructure exists. Here's how the company's approaching the challenge.

• Generative AI Can Write The Code, But Who Builds In The Quality?

  Code democratization demands a return to the fundamentals of quality in pharmaceutical and regulated environments.