06.29.26 -- May 2026 — CDMO Opportunities And Threats Report

Discover how one family defied the odds — bringing a lifesaving gene therapy from idea to treatment in just 14 months after a devastating rare disease diagnosis.

Pre‑approval inspection readiness requires embedding traceability, contamination control, and robust documentation practices into everyday manufacturing to prevent delays and ensure regulatory confidence.

Alternative AAV manufacturing approaches can dramatically reduce cost per dose, improve scalability, and increase yields across serotypes, enabling broader patient access to gene therapies.

Learn how next-generation workflows are being developed to streamline iPSC manufacturing, enhance differentiation strategies, and overcome the hurdles of scalability and consistency.

Early, phase-appropriate CMC planning is critical for advanced therapy success. Proactively managing regulatory risks and applying Quality by Design principles secures a clear path to market.

Accurate AAV capsid ratios are critical to gene therapy efficacy. See how mass photometry delivers faster, lower-cost E/F analysis with single-particle resolution.

Explore the demonstration of precise, site‑specific integration of a 50 kb multi‑gene construct into human iPSCs, overcoming size limits of traditional genome‑engineering approaches.

A next‑gen single‑stranded DNA template improves non‑viral gene editing by boosting viability, knock‑in efficiency, delivery flexibility, and stability while overcoming limits of viral vectors.