GUEST COLUMNISTS

• Tips For Deploying Advanced Modeling In Commercial Phase Bioprocessing

  In-silico tools are ubiquitous in development, but big hurdles prevent them from showing up meaningfully in commercial manufacturing. These tips could help clear them.

• Should You Be Using Unique Container Identification?

  Unique identifiers on glass vials could solve a host of problems. ISPE developed a new guide to help manufacturers apply them on primary parenteral containers.

• The Influence Of Flows In cGMP Architectural Design

  In drug manufacturing facility layout, balancing the roles of layout and procedure plays a critical role. This article examines how the interplay may be resolved, and how this resolution affects facility layout during design.

• NIST, IBBR Researchers Explore Excipient-Influenced mAb Dynamics At Atomic Level

  Nuclear magnetic resonance spectroscopy is powerful technique used to investigate the structure and dynamics of the drug substance in various drug formulations.

• FDA Issues Draft Guidance On Use-Related Risk Analysis (URRA)

  The FDA released a new draft guidance, "Purpose and Content of Use-Related Risk Analyses for Drugs, Biological Products, and Combination Products," in July. The public comment period closes on Sept. 9, 2024.

• This Takeda Official Thinks Pharma 4.0 Won't Be Optional Much Longer

  Advanced technology like automation was once seen only as a competitive advantage. That viewpoint is shifting amid greater reliance on digital technology.

• 2024 Emerging Trends In Cleanroom Technologies

  This article shares new market research on pharma/biotech cleanroom technologies, including regional trends, prominent vendors in the space, and more.