12.09.25 -- Why Early Manufacturing Decisions In Cell & Gene Therapy Matter

Explore the reasoning behind the increasing demand for cleanroom technology as well as the advantages modular cleanroom design brings to the sterile processing of complex therapies.

Take an inside look into the growth characteristics, morphological features, and quality attributes of hMSCs and hiPSCs cultured and expanded advanced in vertical-wheel bioreactors.

Assimilate how comprehensive and effective disinfection solutions can ensure safety and compliance in pharmaceutical manufacturing by managing viral contaminants and enhancing patient protection.

Scalable rAAV production is achievable with a transient cell line and optimized bioreactor setup, delivering high titers and reduced impurities, now validated at 200 L scale for commercial readiness.

With 4,800 immune cell therapy products in development, cytokines are crucial for cultivating diverse immune cells. See how fine-tuning cytokines can enhance cell proliferation and advance immune cell therapy.

Lipid nanoparticles (LNPs) carry immense potential as delivery systems. Learn about the development of isocratic and gradient methods for high-throughput separation of lipids used in LNP formulations.

Demand for EVs is rising due to their therapeutic promise. Explore two scalable platforms that address production challenges to support EVs' expanding clinical and commercial applications.

Delve into a two-part system comprising a proven Sf-9 cell line devoid of Sf-rhabdovirus and a chemically defined medium engineered for it. Explore the performance of this medium for AAV2 production.

Non-viral gene editing is a powerful method for cell therapy. Learn how to address key challenges like cell viability and thermal damage with an innovative approach designed to improve performance.

The EXCiPACT certification for Excipient GMP quality media and buffers ensures the safety, efficacy, and scalability of cell and gene therapies, accelerating development and improving patient access.

Transferring cell cultures between scales is challenging and error-prone. Uncover a bioreactor scaling software that predicts optimal settings to enable efficient scale-up and progression to clinical studies.

Optimize your CHO-K1 GS cell line with advanced chemically defined, animal origin-free feeds. Achieve higher titers and reliable product quality.

Examine a DOE-based study that reveals how buffer conditions impact virus and impurity clearance using a mixed-mode resin, as well as gain practical guidance for optimizing downstream purification.

Discover how custom manifolds enhance allogeneic therapy development from formulation to commercialization by improving process control, scalability, and efficiency.