As more cell and gene therapies become approved for clinical use, there has been a rapid increase in the need for innovative cell manufacturing technologies that can improve product efficiency and maintain cell product integrity while meeting scale-up demands. To overcome this commercialization challenge, it is important to identify process development workflow stages where optimization is necessary, test and qualify new technologies that improve that stage of the workflow, and establish supplier relationships to secure raw materials for scale-up.
In this On Demand webinar our expert panel discuss how to plan the successful development of new cell therapies using emerging raw materials and technologies. During the On Demand the panel will explore:
Following a presentation by Sean Kevlahan, PhD, Senior Director of Cell and Gene Therapy at Bio-Techne, he is joined by our expert panel:
SK: We assess the impacts of process changes on cell performance using panels of flow cytometry antibodies, both before and after transfection/transduction and cell expansion. We also look at cytokine expression using multianalyte immunoassay technologies such as, Ella and Luminex. Our raw materials are designed to minimize variability of performance across culture conditions, but the impact of a raw material change really depends on the culture conditions for your manufacturing protocol.
SK: Any reagent that materially affects the cell therapeutic product, such as cell phenotype and killing potential, should be considered critical. This can include exogenous cytokines, cell activation reagents, and transduction vectors. Critical reagents such as these can be changed, typically during the phase 1 trials, but this becomes harder at later phases because more detailed comparability studies are typically needed.
SK: Manufacturing cell culture media using a aseptic process and providing it in closed-system packaging is important. When possible, sourcing media and other essential raw materials in closed system bags is a way to streamline manufacturing and maintain sterile continuity.
SK: In the United States, follow USP Chapter <1043>, Ancillary Materials for Cell, Gene, and Tissue-Engineered Products. In Europe, follow Ph. Eur. General Chapter 5.2.12, Raw Materials of Biological Origin for the Production of Cell-based and Gene Therapy Medicinal Products. For more information about Bio-Techne regulatory policies visit – https://www.rndsystems.com/products/gmp-quality-policy-and-regulatory-support
SK: At Bio-Techne, we define quality as limited lot-to-lot variability, robust and detailed specifications on a Certificate of Analysis, and products being developed and built using quality by design processes.
SK:Raw materials should follow USP <1043> guidance for ancillary material. Use of Xeno-free or animal-free derived products is preferential.
SK:Only in the absence of a GMP manufactured products should RUO material be used. If using RUO, then it will be important to identify a supplier with high quality product and can provide a stable supply chain through clinical trials.