Featured Bioprocessing Editorial

1. May 2026 — CDMO Opportunities And Threats Report 6/16/2026

   Each month, Outsourced Pharma works in conjunction with PharmSource, part of GlobalData, to present its “Contract Manufacturing: Opportunities and Threats (CMOT) Report” to our readers. The report identifies CDMOs that might be impacted by key events affecting their clients, including company acquisitions, product acquisitions and licenses, product approvals, late clinical product terminations, and FDA rejections.

2. 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.

3. 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.

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. 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.

7. 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.

8. 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.

9. 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.

10. 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.