GUEST COLUMNISTS

• 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.

• A Comparison Of 6 Analytical Validation Guidelines Using Data Envelopment Analysis

  This is the first published application of data envelopment analysis to six major pharmaceutical analytical validation guidelines, including ICH Q2(R2), USP, ChP, and Brazil's ANVISA.

• Affinity Membranes Are Moving Closer To Commercial Reality

  A recent review shows advances in surface chemistry and ligand engineering are moving the needle for next-generation affinity membranes.

• AI Has Arrived In Biotech CMC Amid Patchwork Governance

  AI is surfacing within regulatory and CMC workflows at a vigorous pace. Unfortunately, in small and midsize biotechs, it's happening faster than governance can keep up.