GUEST COLUMNISTS

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• FDA Explains How To Respond To Form 483 Observations In New Draft Guidance

  In March 2026, the FDA issued a new draft guidance titled Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection Guidance for Industry.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

• Solving Glycoengineering Challenges Could Begin At The Cell Line

  Researchers produced a panel of platform cell lines illustrating how glycoform selection can be made experimentally visible earlier in biologics development.

• What Biopharma Often Overlooks In A Scheduled Shutdown

  Shutting down an operating biologics facility upsets systems often designed for continuous operation. One expert shares his tips for preventing unnecessary problems.