Overview
Cell therapy research is a rapidly advancing field. Multiple cell therapies are now commercially available across the world to treat certain hematological disorders. A plethora of clinical trials for investigational therapies addressing a wide range of diseases like cancer, autoimmune disease and genetic disorders are using autologous or allogeneic cells with rapidly evolving cell engineering and editing approaches. A common theme in cell therapy research is the need to understand cell phenotypes and heterogeneity at every step of the process, including characterization and development of predictive biomarkers and cells isolated from patients as input for cell therapy manufacturing.
Flow cytometry is a powerful tool to characterize cell phenotypes to define critical quality attributes for cell therapy products such as cell viability, identity, potency and purity. Flow cytometry assays are performed at different stages during the development and manufacturing of cell therapy products. Assays are often transferred between multiple manufacturing sites for the final release and QC of therapeutic products.
A Flow Cytometry Partner
at Every Level
BD Biosciences is your global partner in single-cell analysis. We provide extensive scientific resources and tools that enable high-dimensional analysis, automation and standardization because we are committed to partnering with you so that you can advance your cell therapy research programs by delivering high-quality solutions that support your 21 CFR Part 11 compliance.
Cell Therapy Development Journey
Research & Development
During the early stages of cell therapy research, a critical priority for process and product development is to characterize starting material and understand the biology, cell phenotype and function while maximizing data output. Our flexible innovative high-throughput single-cell multiomics platform and high-dimensional flow cytometers allow in-depth characterization of cell function and research for the development of predictive biomarkers.
Manufacturing QC
In cell therapy manufacturing QC, BD’s automated and easy-to-use research flow cytometers, certain of BD’s research reagents manufactured according to GMP standards, and BD’s software that support your 21 CFR Part 11 compliance and lab information systems may be crucial for your product release in accordance with GMP guidelines by the European Medicines Agency (EMA) and U.S. Food and Drug Administration (FDA).
All user-defined flow cytometry research assays used for manufacturing QC release of products must be validated and verified by the user. The user must comply with applicable local regulations and obtain appropriate Health Authority approval as necessary for their intended use.
Optimizing manufacturing processes to reduce complexity and improve scalability requires use of automated technologies. Flow cytometry solutions that are standardized across instruments allow data comparison and consistency of results across manufacturing sites and seamless tech transfers.
