GUEST COLUMNISTS

• A Year In, Sanofi's Journey With Plai AI Is Aiding Quality Decisions

  Sanofi has been a vocal of advocate of AI/ML for years. Here's how it's using technology to facilitate the audit process and get to the bottom of deviations faster.

• Drug Product Formulation & Process Development: The Must-Have Skills At A Glance

  Specialists in drug product formulation and process development at small biopharmas need to balance scientific knowledge and multidisciplinary know-how across the stages of product development.

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• FDA Issues Draft Guidance On Use-Related Risk Analysis (URRA)

  The FDA released a new draft guidance, "Purpose and Content of Use-Related Risk Analyses for Drugs, Biological Products, and Combination Products," in July.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.