11.03.25 -- Best Practices When Working With A CDMO

This roundtable weaves together diverse perspectives from across the industry, providing a multifaceted look at what it will take to create a sustainable path forward in rare disease drug development.

To ensure the long-term success of gene therapy programs, learn why it is crucial to partner with a CRO that not only understands the science but can navigate the challenges of viral vector development and testing.

A cost-effective approach with a comprehensive AAV analytical package holds the potential to advance the application of rAAV in cell and gene therapy for the treatment of human diseases.

Discover the potential of T1 cell-derived nanoparticles (CDNPs) to accelerate T-cell activation. See how CDNPs’ unique mechanism of mimicking physiological immune stimulation positions them for broad use.

By working with a single supplier that manages the manufacturing value chain—from early development through final production—companies can reduce risk, improve operational flexibility, and accelerate their time to market.

To overcome persistent manufacturing bottlenecks and reduce the high cost of gene therapies, our ATLAS platform has identified novel factors that significantly boost rAAV9 production over 30-fold.

Assimilate more about the potential of allogeneic cell therapies to combine the efficacy of personalized medicine with the scalability, accessibility, and uniformity of traditional off-the-shelf therapeutics.

Despite rapid approvals, ATMP patient access is limited by operational bottlenecks. Successfully delivering these complex therapies demands tightly synchronized logistics and resilient contingency planning.

Unlock deeper insights into the immune system with spectral flow cytometry — a powerful tool to drive cell therapy development, optimize treatments, and improve patient outcomes.

Choosing the CDMO best suited to manufacture your rare disease therapy can be challenging. Ideally, a CDMO will prioritize your goals while working to ensure quality and regulatory success.

Grasp the strategies for Annex 1 compliance, focusing on Contamination Control Strategy, Pre-Use Post Sterilization Integrity Testing, and critical zone controls to secure aseptic manufacturing processes.

From identity and purity testing using chromatography and electrophoresis to PCR and microbial studies, explore advanced analytical solutions tailored for siRNA, miRNA, pDNA, and mRNA products.