High quality flow cytometry service to support your development from pre-clinical to clinical sample analysis
- Tailored to your specific needs
- Underpinned by extensive Tissue Culture Facility
- Access to in-house panels
- Experienced Principal Scientist team
- Validated 21 CFR part 11 Compliant Acquisition & Analysis software
- Collaboration with National Measurement Laboratory
Contact us to discuss flow cytometry
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 run GxP regulated studies & provide full method development & validation services. Alongside our established PK, PD & immunogenicity testing, our flow cytometry service provides supplementary quantitation of immunological endpoints.
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-ligand binding assays (receptor occupancy)
• Intracellular cytokines
• Cellular activation
Flow Cytometry Platform
- Two Beckman Coulter CytoFLEX, 3 laser
- Two configuration matched instruments
- 13 Fluorescence, Standard FSC/SSC+ Violet SSC
- Cross Standardized for each assay
- Linearity, >99%
- Fully Validated to current guidelines (2021)
- Dedicated Cell Culture and handling
- Cell washer for improved precision
- Technical specialist team
- FCS Express Fully validated to current guidelines
- All assays are Aligned with current H62 guideline (published 2021)
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.