GUEST COLUMNISTS

• Transforming Computer System Validation In The Life Sciences Industry

  Regulators acknowledge how traditional CSV methods fail to meet modern demands for speed and flexibility. The scene is changing in favor of smarter, leaner validation.

• Analyzing And Managing CDMO Project Risks Using Causal Mechanism & Effect Analysis

  Since every sponsor–CDMO relationship can have widely different scopes, requirements, and procedures, this article focuses on the basic principles for analyzing and managing the risks of not achieving the relationship’s objectives.

• Achieving Annex 1 Compliance In Sterile Manufacturing, Part 3: Building A Compliant Program

  In this third and final article of this series, let's take a closer look at what a well-constructed Annex 1-compliant program looks like at each stage, from gap assessment through governance.

• An Open-Source Modeling Tool For Suspended Continuous Lyophilization

  Building on a continuous suspended-vial lyophilization workflow, process developers can model critical variables before doing physical experiments.

• Mapping Early-Phase Supply Chain Bottlenecks That Doom Pipelines

  Many sponsors miscast preclinical development as an unglamorous step between discovery and the clinic. Here's how the consequences may lead to irrevocable losses.

• Achieving Annex 1 Compliance In Sterile Manufacturing, Part 2: Objective Measurement Tools

  Let's examine the objective measurement tools that directly address each of the gaps between Annex 1 expectations and what drug manufacturing facilities can currently demonstrate in practice.

• FDA Explains How To Respond To Form 483 Observations In New Draft Guidance

  In March 2026, the FDA issued a new draft guidance titled Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection Guidance for Industry. Let's take a closer look.