11.13.25 -- Designing Early Manufacturing For Long-Term Success In CGT

Proactive, risk-based oversight must be established to manage outsourced GXP activities. This requires a robust QMS and comprehensive quality agreements to safeguard product quality and data integrity.

Adopt next-generation, physiologic T cell activation strategies to enable faster, more consistent, and scalable CAR-T manufacturing that improves expansion, persistence, and patient access.

Explore the current state-of-the-art in RNA nanoparticle formulation, examining the technologies and strategies used to optimize RNA delivery for preclinical and clinical development.

Using cells with a pre-engineered TARGATT™ landing pad, we achieve inducible expression within just 4-6 weeks after donor plasmid creation, significantly reducing development time and effort.

This study aims to explore the kinetics of capsid formation and impurity profiles over time, offering insights that can inform future process improvements and optimization strategies.

See how this label-free whole-body QMSI combined with plasma LC-MS/MS can help identify the root causes of limited bioavailability and guide smarter optimization strategies early in development.

Ensure cell therapy products are consistently manufactured with safety, quality, and potency, supporting regulatory approval and successful clinical development.

Infectious disease mAb therapies are entering clinical trials at a record pace. Review the trends driving the use of mAb treatments as well as key considerations to remain competitive in the race to market.

Uncover how a proprietary transposase technology works and why it can be beneficial for enhancing the development process for the efficient expression of biologics.

Discover how a Microbubble Cell Separation System outperformed standard magnetic methods in T cell recovery, speed, and scalability — achieving higher cell quality with an innovative microbubble technology.

This comprehensive exploration aims to shed light on the critical aspects of expediting curative therapies, with a focus on the strategic role that CDMOs can play in this transformative journey.