02.02.26 -- 2026 CDMO Forecast: The 7 Shifts Sponsors Need To Prepare For

To manufacture your rare disease therapy cost effectively, partner with an experienced CDMO from the outset. The right partner will offer development, manufacturing, quality, and regulatory expertise.

Quality is the foundation of leadership and operations, ensuring that collaboration and strategic focus will deliver safe, effective cell therapies without compromising patient safety or regulatory standards.

Adrulipase spray-dried dispersions were evaluated to create an orally delivered, enteric-protected enzyme. Investigate how the lead formulation provided the best acid protection, rapid release, and stability.

See how one family managed to get an investigational gene replacement therapy manufactured and approved by the FDA so their daughter could be dosed just 14 months from her diagnosis.

Accelerate cell and gene therapy development with high-yield, regulatory-compliant plasmid DNA manufacturing that shortens timelines, minimizes risks, and streamlines your supply chain.

Discover how LETI-101 uses AAV5 to deliver a compact CRISPR system to the brain, showing promise as a one-time treatment for Huntington’s disease with strong preclinical safety and efficacy.

Silencing lentiviral cargo genes boosts vector yield, enhances cell viability, and reduces impurities, enabling scalable, cost-effective manufacturing for complex gene therapies.

Early product characterization can serve to uncover crucial information about an advanced therapeutic candidate, affording new insight into its CQAs and helping to shape better analytical assays.

Learn how process analytical models can monitor key CQAs, such as RNA concentration and nucleoside triphosphate consumption, and explore RBP and MIT’s vision for revolutionizing biomanufacturing.