12.16.25 -- Could Chicken Wisdom Help Cell Therapies Spread Wings?

This chapter discusses basics of gene therapies, including function, anticipated growth rates, companies involved and estimates of therapies in pipeline, and examples of commercial products and indications.

Equip yourself with the knowledge necessary to make well-informed decisions by exploring the main challenges and considerations inherent in cell therapy process development.

Gain insights into the nuances of cleanroom conceptual design for GMP operations and learn how an integrated approach can ensure regulatory compliance, functionality, and environmental performance.

Equine mesenchymal stromal cells (eMSCs) offer therapeutic potential for various conditions. Dive into the examination of eCB-MSCs using microcarriers for enhanced cell yield, reproducibility, and homogeneity.

Traditional biomanufacturing relies too heavily on trial and error. By integrating AI and mechanistic models into early design, developers can overcome productivity limits and accelerate timelines for therapeutic modalities.

See the development of a novel Sf-RVN® cell line, with a companion chemically defined medium, which can be combined and offer a Sf-Rhabdovirus-free alternative for the BICS production of biologics.

Whether you are preparing to launch your first ADC study or looking to optimize current programs, this session will deliver practical insights you can put into action immediately.

Gain a foundational understanding of the process for culturing mesenchymal stem cells in stirred-tank bioreactors and learn about the key parameters for successful scale-up.

As oligonucleotide-based drugs gain momentum in therapeutic development, refining their manufacturing processes through solutions like ion exchange chromatography (IEX) becomes crucial.

As CGT developers gain knowledge about their processes, single-use technologies (SUT) manufacturers can better address the sector's unique autologous needs by adapting to smaller volume production.

A key reason why mRNA is considered such a significant breakthrough is its potential to enable drug development. Learn about the development hurdles that must be overcome to deliver on the promise of mRNA.

Explore how tangential flow filtration (TFF) systems streamline lentivirus purification to enhance efficiency and scalability in CAR-T cell production, which is a crucial advancement in cancer immunotherapy.

Media selection is key to CAR-T cell success. Assimilate how a serum-free, xeno-free medium boosts transduction efficiency, maintains quality, and streamlines the path to clinical scale-up.

Discover NIH's innovative solution to clinical-stage viral vector production: Delve into how two mobile cGMP facilities deliver adaptability and compliance to Bethesda's National Institute of Health.

Master how automated workflows are addressing challenges in cell therapy production, from reducing errors to ensuring data security and compliance.