11.17.25 -- Are You Still Evaluating CMOs When You Really Need A CDMO?

To prevent path-to-market setbacks, it is critical to develop a Chemistry, Manufacturing, and Controls strategy that proactively identifies scientific and compliance gaps, as well as mitigates risk.

Effective AAV vector shedding assessment is crucial for gene therapy trials. Optimizing qPCR assay sensitivity across complex matrices is key, as is controlling for reagent-based variability like binding buffer acidification.

Review the importance of alternative approaches to viral vector production and the benefits of intensified adherent cell culture for improving efficiency, reducing costs, and accelerating development.

Discover how a systematic and scalable approach to autologous cell therapy manufacturing can help reduce costs, improve reliability, and accelerate patient access to life-changing treatments.

To evaluate performance, we compared a suspension process with an adherent iCELLis (200 m²) system, assessing upstream and downstream recovery, as well as analytics using an AAV testing platform.

Recognizing and integrating diversity, equity, and inclusion (DEI) is essential for fostering innovation, improving team performance, and ensuring long-term competitiveness in a global market.

Enhance the success of your research and cell therapy programs by sourcing high-quality PBMCs with proven functional performance, donor-specific insights, and consistent availability to support your workflows.

By leveraging this innovative combination, the assay achieves detection limits comparable to traditional methodologies while enhancing overall efficiency and reliability.

When it comes to furthering AAV's potential in the wider biopharmaceutical pipeline, partnering with a CDMO that can foment an optimal analytical and manufacturing strategy is crucial.

Explore some of the key considerations in cell line development, how advances in technology are improving the efficiency and productivity of cell lines, and the future of cell line development.

Examine advanced analytical solutions that detect, characterize, and mitigate particle formation in high-concentration biotherapeutics caused by protein aggregation and surfactant degradation.

Mathias Kahl, Director of Process Development, shares insights on overcoming challenges in AAV and LV viral vector manufacturing, including strategies for improving scalability, consistency, and overall process efficiency.