With the growth of the biopharmaceuticals industry, the impact of biological drugs on the immune system has been a key area of investigation for pre-clinical and clinical drug development. Flow cytometry provides an ideal tool to examine this impact, allowing the interrogation of immunological changes at the level of a single cell to define drug related effects.
Our flow cytometry service offers a range of assays to support pre-clinical through to late phase drug development. With two 13-colour, Beckman Coulter CytoFLEX cytometers, Drug Development Solutions is well equipped to meet your bioanalytical needs. Both instruments are fully validated to meet GLP and GCP regulatory guidelines.
Complex Assay Development
We have a breadth of experience in the development of complex cytometry end-points, in both human samples and a range of pre-clinical species, including:
• Receptor Occupancy
• Intracellular cytokines
• Cellular activation
Regulations in Flow Cytometry
For method development and validation, we follow the current industry standards for fit-for-purpose flow cytometry method validation and offer a full method development and validation service. At present, there are no formal regulatory guidelines available for the validation of Flow Cytometry assays.