GUEST COLUMNISTS

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• FDA Explains How To Respond To Form 483 Observations In New Draft Guidance

  In March 2026, the FDA issued a new draft guidance titled Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection Guidance for Industry.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

• Achieving Annex 1 Compliance In Sterile Manufacturing, Part 1: Common Compliance Failures

  A persistent gap remains between what Annex 1 requires and what facilities can demonstrate. Let's take a closer look at four common compliance failures.

• Is Your AI Model Trustworthy And Credible In GMP Processes?

  Credibility and trustworthiness in AI models are related but distinct attributes. If you're using them in GMP manufacturing, you should understand the difference.