09.29.25 -- CDMO Opportunities And Threats Report

If you’re hoping to improve your QC toolkit to better accommodate complex modalities like cell and gene therapies, it's time to build a program that accounts for risk and unique product characteristics.

Safeguard your cell banks with secure, compliant storage and streamlined delivery solutions that keep manufacturing on schedule and therapies moving forward.

Review more details on the FDA expedited review programs, the incentives for obtaining such designations, and the required information/data to better position your investigational product for success.

Explore nucleic acid extraction approaches for PCR analysis, emphasizing best practices, matrix-specific strategies, validation, normalization, and troubleshooting in cell and gene therapy applications.

Discover how scalable innovation is transforming viral vector production and driving broader, more equitable access to advanced gene therapies.

Build a reliable, de-risked path to the clinic while avoiding unforeseen costs and compliance-related delays with advice from Suparna Sanyal, Ph.D., Head of Viral Vectors Commercial Development.

Explore how to select the right CDMO partner for your pharmaceutical project to navigate the evolving drug development landscape from discovery to commercialization and ensure successful outcomes.

Streamline cell therapy development by transforming complex cellular characteristics into a predictive, multiparametric metric that guides the selection of high-potential starting material.

Explore the building blocks of plasmid manufacturing capability, highlighting how one approach supports AAV programs by helping manage production costs while maintaining high productivity.

Gain insight into end-to-end plasmid DNA solutions, leveraging robust cGMP-compliant processes and single-use manufacturing platforms to accelerate your cell and gene therapy programs.