Finding a laboratory to successfully transfer and GLP validate your PK method can be a challenge. Yes sure the big labs can do it, but if you are not a preferred provider you may find yourself working with the B team that doesn’t move as fast as you need, and that at a higher cost – both in actual dollars as well as the cost of time. At KCAS Bioanalytical and Biomarker Services we take an orchestrated approach to get your assay in tune with our process, and I’d like to show you how we do that.
In drug development, PK testing of a compound is performed to determine the drugs distribution, absorption, metabolism and/or excretion after administration to an animal or human. The performance characteristics of the method are critical to enable scientists to have confidence in the results, which allows physicians to evaluate how a drug should be dosed to patients.
When a PK method is first developed and qualified in a non-GLP lab or an academic institution, it’s not a simple transfer to a GLP environment. The method is often not able to pass the rigors of a GLP validation. In our experience, qualified methods fail selectivity, stability, or GLP accuracy/precision acceptance criteria. Additionally, the quality control levels are not designed to meet GLP requirements.
Recently, we validated a PK assay that had been previously qualified by an academic lab. After the first few transfer experiments it became clear this method was not going to pass a GLP validation. We proceed to redevelopment the method using our standard ELISA process for blocking the plate, the plate type, and incubation times and practices, which have been engineered to meet GLP validation guidelines. We successfully lowered the LLOQ 15-fold. The validation passed both FDA and EMA guidelines.
Have you ever had a PK method performing flawlessly in your research lab, but when transferred to a CRO they can’t get it to work? You may have even gone to the length of going to the CRO to show them how to perform the assay, yet they still can’t get it to pass a GLP validation. What we do at KCAS to avoid this issue is we take the assay and incorporate it into our process. We don’t change the building blocks (capture antibody, detecting antibody, and drug), but we incorporate those building blocks into our process for optimization and validation of PK assays. Think of your assay as an instrument in the orchestra. We tune it to the oboe, and together with all of the other instruments (assays running in our lab), the concert begins.
If you need a PK assay for detection of your drug, whether it be a humanized monoclonal antibody, chimeric protein, endogenous protein, cytokine, enzyme replacement, or fusion protein, and either don’t have a lab in mind, or are working with a CRO who is not proficient with the performance characteristics acceptance criteria for GLP assays, we look forward to starting a conversation to see if we can provide you reliable and defendable data for your drug development program.
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