KCAS is a rapidly growing industry leader that continues to increase its vast knowledge surrounding assay transfers not only internally but externally as well. As KCAS expands as a global leader in the bioanalytical space we have taken our knowledge surrounding internal assay transfers and extended that knowledge to external transfers whether it be another lab in another region of the world or transferring an assay to another laboratory in a cross-validation setting. Our industry leading development and validation teams are proficient at transferring assays between the groups as well as the transfer of assays between KCAS labs, whether that be to another group within the same facility or to a KCAS lab in another region of the world. There are several crucial aspects of assay to consider when thinking about assay transfer.
A successful assay transfer always begins with method development. KCAS’s method development scientists have decades of experience and knowledge to developed robust methods. When starting method development, it’s important to start with high quality critical reagents. When evaluating commercially available critical reagents, it’s essential to evaluate availability, lot to lot variability, and stability. Robustness is another key parameter to assess when developing an assay that will be transferred. This parameter evaluates the variability of the assay using different analysts, different days, different instruments. Another critical aspect of assay transfer is ensuring well written and detailed SOPs and test procedures are shared by KCAS’s operations team to the receiving lab. KCAS’s method development team transfers hundreds of assays internally per year. We understand the significance of an assay transfer step for the success of a study.
Cross validation guidelines have continued to evolve over the years. In the recent ICH M10 Guideline it states cross validation should be assessed by measuring the same set of QCs (low, medium, and high) in triplicate and study samples should span the concentration range of the assay in both laboratories. When available, at least 30 study samples should be used. There are no specific guidelines regarding cross validation of immunogenicity assays, however, reproducibility should be determined between laboratories. Comparable assay performance, including sensitivity, drug tolerance, and precision should be established between laboratories.
Open communication and close collaboration between KCAS and the client as well as between labs are the key to a successful assay transfer. Whether it be assay transfer between departments at KCAS, harnessing their internal knowledge to transfer an assay to another lab, or assist a client with a cross validation, we at KCAS have been able to extend our assay transfer knowledge to help our clients with successful method transfers to labs across the globe.
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