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. Inside AstraZeneca's Fully Electrified Cell Therapy Facility 6/5/2026

    The company won an ISPE FOYA for its Rockville, Maryland, manufacturing site that boasts 100% uptime and flexible capacity to produce thousands of batches annually.

  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. 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.

  6. 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.

  7. Mastering Temperature Control And Advanced Therapy Logistics In Global Clinical Supply Chains 6/3/2026

    Cold chain failures can derail patient dosing in global trials. Real-time visibility and predictive logistics are becoming mission critical.

  8. 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.

  9. 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.

  10. 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.