Immunophenotyping

Method Transfer

Let our experts collaborate with your team. We know that method transfer is an important step and requires careful attention. A quality method transfer is a fundamental step to ensure consistency and reliability of results across different locations and phases of clinical trials. Whether your assay is ready for an “as is” transfer or requires some additional optimization, we are poised to help.

Method Development

The critical first step for successful development is understanding the assay’s research application. This ensures that the sample matrix, flow cytometry panels, and gating strategies can be designed and optimized accordingly and assures adherence to all regulatory guidelines and principles (Good Laboratory Practice GLP, Good Clinical Laboratory Practice, GCLP). With a firm understanding of the research application, we carefully select the antibody clones, fluorochromes, titrations, and sample matrices during method development and optimization. 

Method Qualification

(or Method Validation) Once custom development is complete, the assay may undergo method qualification or validation, depending on the end application. This fit-for-purpose step will ensure the assay is robust and reliable. At KCAS Bio, we adhere to rigorous standards. All method validations are completed according to the Clinical and Laboratory Standards Institute (CLSI) H62 guidelines for validation of assays by flow cytometry.  Evaluation parameters can include: stability, robustness, precision, accuracy, linearity, Limit of Detection, and Limit of Quantitation. 

Which way to go?

When considering the application of flow cytometry in your study, understanding the difference between Method Qualification and Method Validation is crucial to deciding which is appropriate for your needs.

Method Qualification

Advantages​

Method qualification ensures that a flow cytometry method is suitable for its intended use. Customizable to meet the assay need, it typically involves fit-for-purpose test scripts demonstrating that the method can reliably identify and quantify cell populations of interest. ​

When to Use​

Method qualification is generally used in preclinical studies, early-phase clinical trials, or exploratory research, where the regulatory requirements are not as stringent and the primary goal is to gather preliminary data.​

Method Validation

Advantages​

Method validation is a comprehensive process establishing that a flow cytometry method is reproducible and reliable for specific clinical or regulatory purposes. Unlike many other platforms, flow cytometry lacks target standards from regulatory agencies, so validation strategies and approaches differ across laboratories. The validation should be designed to thoroughly evaluate various parameters and be prepared to meet strict regulatory requirements. This is critical for later-phase clinical trials and studies that will be submitted to regulatory bodies. ​

When to Use​

Method validation is recommended for late-phase clinical trials, regulatory submissions, and studies where the accuracy and reliability of the data are paramount.​