03.19.24 -- 5 Considerations When Licensing Cell Or Gene Therapy Products

To ensure product quality, manufacturers must disinfect as well as clean the cleanrooms they use. Explore considerations for anti-microbial agent selection, steps for successful disinfection, and more.

Due to the flexibility and reduced burdens that they offer, decentralized clinical trials have the potential to positively impact all stakeholders, most importantly, the patients.

AI is dramatically reshaping the manufacturing environment. Uncover a proactive approach to digitizing technology, an integrated digital strategy for workforce management, and much more.

Analyze an experiment conducted to validate a macrophage suppression assay workflow and demonstrate a consistent in vitro macrophage suppression assay used in the validation process.

Review the suggested method for adapting hPSCs originally cultured in Essential 8 Medium (E8) to NutriStem hPSC Medium.

Experts discuss how to develop robust, scalable, and cost-effective processes that yield high titers of high-quality viral vectors.

From tumor resection to therapy delivery, there are a number of hurdles at each stage of your TIL therapy manufacturing workflow. Here, we address key challenges at each stage of the workflow.

As cell and gene therapies grow in the pharmaceutical industry, drug sponsors must determine how to successfully navigate evolving regulations, study design considerations, and a lack of animal models.

Current advances in cell, gene, and tissue therapies require a rethinking of how — and where — cleanroom manufacturing facilities could be built, enabling more options for sponsor process control.

Mesenchymal stem cells have been used to show equivalent expansion kinetics during a seven-day expansion protocol on both the small and standard bioreactors, revealing efficiency differences.