Industry Insights

1. Bringing Next-Gen Sequencing To GMP Scale 9/10/2026

   NGS enables broad detection of known and novel viruses in a single assay. Its high sensitivity, specificity, and scalability can meet GMP throughput levels.

2. Risk Managing Through The Void Of ATMP Visible Particle Guidance 9/8/2026

   Regulators expect cell therapy manufacturers to prove they control for visible particles, but guidance remains notably quiet on the matter. Companies must get creative or risk clinical holds.

3. Engineering CAR T Cells With mRNA-LNPs: Applying Oncology Learnings To Allergic Diseases 9/4/2026

   Targeted lipid nanoparticles (LNPs) could deliver mRNA encoding a CAR directly to T cells inside a patient with allergic disease. The potential implications extend beyond a single allergic condition. 

4. The Promise Of MRD-Guided CAR-T Treatment 9/3/2026

   Minimal residual disease markers can reveal relapse before clinical signs appear, when off-the-shelf cell therapy may have its greatest advantage.

5. CDMO Quality Oversight: How FDA And Pharma Leaders Are Rethinking Data, AI, And Culture 9/2/2026

   Discover strategies for risk-based governance, AI-enabled quality management, stronger collaboration, and fostering a culture that supports long-term operational excellence.

6. Autoimmune CAR T Has Hit A Critical Moment. Are We Asking The Right Questions? 9/2/2026

   The promise of autoimmune CAR T is enormous, but recent safety pauses from Novartis and BMS underscore why the field needs a more patient-centered approach to risk, clinical outcomes, access, and real-world delivery.

7. A QMS That Anticipates Cell And Gene Therapy Quality Challenges 9/2/2026

   Some quality system elements are non-negotiable in Phase 1 cell and gene therapy. For the rest, a risk matrix can help define flexible, defensible specifications.

8. Using Digital Platforms To Find Your CDMO 9/2/2026

   In recent years, digital platforms have emerged to help pharma/biotech companies discover, evaluate, and connect with CDMOs more efficiently. These resources have different functions and limitations.

9. July 2026 — CDMO Opportunities And Threats Report 9/1/2026

   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.

10. ADC CDMO Selection For Small Biotech 8/31/2026

    Manufacturing is a critical factor in ADC success. Discover how to align CDMO capabilities with molecule complexity, mitigate risks, and navigate capacity limits.