GUEST COLUMNISTS

• FDA Explains How To Respond To Form 483 Observations In New Draft Guidance

  In March 2026, the FDA issued a new draft guidance titled Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection Guidance for Industry.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

• Where Does 3D-Printed Single-Use Tech Fit In The Development Pipeline?

  Additive manufacturing in early-phase process development is growing more common, but the practice comes with important considerations.

• Use Of AI In FDA Inspection Activities: Strategies For Effective Preparation

  Are you ready? FDA has begun to implement the use of artificial intelligence in its operations, particularly during inspection activities.