GUEST COLUMNISTS

• 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.

• UK's Decentralized Manufacturing Could Be A Revolution; Mind The Risk

  Decentralized manufacture will only improve patient outcomes if the pharmaceutical quality system at the control site is strong enough to carry the weight of the network.

• All The Ways Global Biopharma Still Grapples With Annex 1

  Biopharma companies can't consistently meet Annex 1 expectations. At the heart of the problems, regulators have shifted the burden of proof to manufacturers.

• Clearing The Fog On New First Air Visualization Expectations

  Assessing first air using standard smoke studies is qualitative in nature, and it's difficult to establish clear criteria. Here is how regulator positions are evolving.