03.12.24 -- Examining The 2024 Regulatory Landscape Of CGT

Read about the benefits of automated data capture for clinical trial researchers and how teams within the cell and gene space are getting the help they need amidst added pandemic and protocol stress.

Here, the authors demystify why the determination of biodistribution in preclinical and early clinical phases is an essential aspect of developing these novel cell and gene-based therapeutics.

One of the most intriguing, high-stakes aspects of R&D is the realm of biosimilars. Explore the challenges of biosimilar production as well as aseptic processing considerations for biosimilars.

If you're a CGT manufacturing company transitioning to automation, consider the strategies and manufacturing road map provided herein and how they can improve efficiencies in development.

Explore approaches for the capture and separation of capsids, upstream strategies for reducing the level of empty and partially filled capsids, trends in AAV capsid design impacting purification, and more.

Learn about a scalable process for the production of rAAV using triple plasmid transfection of suspension cells in an animal-derived component-free medium.

For R&D and PD applications, closed single-use systems can protect against both biological and cross-contamination, saving valuable research time and money.

There are three major options when building a pharmaceutical grade cleanroom on your existing site — stick built, modular, or podular. Here, modular installation and stick built construction are compared.

Support reproducible culture processes and media preparations for a variety of cell lines by routinely monitoring slight changes in media components as the serum is added to the basal media formulations.

Gain an understanding of gene therapy, including its history, advantages, disadvantages, and in vivo and ex vivo processes, and how organ-chips can be utilized to advance gene therapy development.

As the cost of developing a biologic drug remains high, explore ways to improve your CLD process by eliminating bottlenecks in clone selection, fast-tracking timelines, and reducing costs.

A test conducted on a novel fragmentation mode for the detailed characterization of lipids reveals information that can be used to determine drug efficacy and safety from formulated LNPs.