Guest Columns

  1. FDA's Guidance On Cell And Gene CMC Codifies Flexibility 6/11/2026

    The final guidance articulates common practices around validation, stability data, and reserve samples that, up until now, had been applied on a case-by-case basis.

  2. 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.

  3. Emerging Technologies In Aseptic Processing: Hype Vs. Operational Reality 6/8/2026

    Let's debunk the misconception that robotics, gloveless systems, or fully closed isolators automatically result in Annex 1 compliance for cell and gene therapies.

  4. 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.

  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. Managing Organic Impurities And Nitrosamines In APIs 6/4/2026

    How API manufacturers can assess and mitigate organic impurities and nitrosamines using risk-based strategies aligned with global regulatory expectations.

  7. 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.

  8. 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.

  9. 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.

  10. 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.