Guest Columns

1. Where Does 3D-Printed Single-Use Tech Fit In The Development Pipeline? 6/10/2026

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

2. Use Of AI In FDA Inspection Activities: Strategies For Effective Preparation 6/8/2026

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

3. A Comparison Of 6 Analytical Validation Guidelines Using Data Envelopment Analysis 6/5/2026

   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.

4. Affinity Membranes Are Moving Closer To Commercial Reality 6/5/2026

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

5. AI Has Arrived In Biotech CMC Amid Patchwork Governance 6/3/2026

   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.

6. Avoiding Common Pitfalls In CDMO–Sponsor Relationships Through Integrated Execution Models 6/2/2026

   Let's delve into the key pitfalls to avoid when working with a CDMO and the integrated execution model that solves or mitigates these pitfalls before they occur.

7. The Future Of Continuous Is Integrated Manufacturing: The 4 Misconceptions About A Lean Process 6/2/2026

   Pharmaceutical continuous manufacturing is an enabler of better manufacturing, but only when implemented with intention.

8. CDMO Selection: Start With The Relationship, Not The RFP 6/1/2026

   Friction often comes from unspoken expectations. Before production begins, treat the combined sponsor-CDMO group as one extended team and intentionally make “how we work together” visible.

9. Why FAT Should Confirm Alignment, Not Reveal Its Absence 6/1/2026

   In many aseptic fill/finish projects, the factory acceptance test (FAT) has become the first true integration test of the entire project. That is a problem. Here's how to flip that mindset.

10. What Reliance, Annex 1, And AI Mean For The Future Of GMP 5/29/2026

    EMA’s Brendan Cuddy explains how regulators are adapting oversight to global supply chains, new technologies, and growing operational complexity.