03.16.23 -- Global Market Outlook On Stem Cell Manufacturing

Determining the appropriate critical tasks to be evaluated and assessed is crucial to the human factors engineering (HF/HFE) process and needs to be addressed with the appropriate risk-based approach.

The road to final approval for a biotherapeutic is long and filled with obstacles, from manufacturing and scale-up to regulatory adherence and business practices.

Learn more about how allogeneic approaches have the power to revolutionize the use of CAR-T cell therapies.

We present a simple protocol for scaling up AAV production using HEK293 host cells cultured in suspension and under serum-free conditions.

Learn about the three most common sources of filtration failures and how to prevent these problems.

Surmounting some of the challenges related to AAV manufacturing and scale-up represents an important opportunity for the advanced therapeutics sector.

Learn how to approach key challenges in CRISPR cell and gene therapy development such as regulatory hurdles, ensuring consistency, finding qualified and experienced staff, and obtaining GMP-grade reagents.

Cell therapy process development is nearly impossible with current tools. Discover a platform that enables cell therapy therapeutics developers to build a more robust and understood manufacturing process.

The objective of this study was to test transfection of T cells with GFP mRNA for evaluation of cell viability, transfection efficiency, and post-transfection growth using Kytopen’s Flowfect technology.

The world is heavily burdened by glaucoma, which is the second-leading cause of blindness and the primary cause of irreversible blindness. Learn about its effects in the Asia Pacific.

In this article we review how particulate removal through filtration affects column life and how to handle difficult-to-filter samples.

Listen as Rachel Smith, portfolio director at Veristat, reviews considerations for setting up natural history studies and the value they bring to rare and ultra-rare clinical research, despite the challenges in their design.

Learn more about a system that uses a gentle elutriation process to give manufacturers a cleaner cell population to begin cell therapy production processes such as CAR-T.

Examine open small format tubing in cell and gene therapy labs – and what technologies are on the horizon to help make more sterile connections going forward.

Learn more about current research on perfusion technology for expanding autologous T cells and the step you should consider when expanding your own T cell manufacturing process.

Explore ways to make establishing MSCs and exosomes within programs, scaling them for product and process development, and translating them into the clinic easier.