GloGen’s team has great expertise in the development of analytical methods and can quickly perform bioanalytical method development and validation of sensitive, accurate and robust PK assays. Our analytical scientists have experience working with plasma, serum, urine, other tissues, and will optimize the extraction conditions to provide a reproducible and robust method.
GloGen has temperature controlled and monitored chambers to properly store sensitive samples prior to analysis. Method validations typically include an assessment of pre-preparative stability to demonstrate that drug residues in tissues are stable over the course of the study.
In addition to our in-house capacities, we have strategic alliance with large molecule analysis lab to leverage capacities for PK sample analysis, Immunogenicity & NAB for Biologics and Biosimilar.
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