Ligand Binding Assays: LBAs continue to be the primary tool used in the biopharmaceutical sciences to quantitate proteins and anti-drug antibodies in biological fluids and tissues. This assay platform is a useful tool used from early drug discovery, through preclinical toxicology work, and clinical studies.
LC-MS/MS: Combined with various sophisticated sample preparation techniques, LC-MS/MS is used to meet bioanalytical needs for drug discovery, preclinical, and clinical studies, including bioanalysis of drugs and metabolites, biomarkers, and active endogenous compounds in biological fluids and tissues.Â
Antibody drug conjugates (ADCs) remain a popular oncology therapeutic modality. ADC analyses require. . .
The translation of an assay from Discovery to Preclinical/Clinical is an important part of drug deve. . .
Colorimetric analysis is a method of determining the concentration of a chemical element or chemical. . .
Affinity capture elution (ACE) is a method used in detecting ADA to increase the assay drug toleranc. . .
Aggregate analysis is done to identify potential protein aggregation that can contribute to the over. . .
The analysis of free amino acids (20 naturally occurring) in plasma or other biological matrices thr. . .
Cell based neutralization assays encompass a variety of methods that can be utilized in the developm. . .
Cell based assays are highly specialized in vitro methods that can evaluate the functional and bioch. . .
Regulated clinical bioanalysis is a key focus at KCAS. Our data has been used in the approval of ove. . .
Critical reagents are essential components of analytical methods whose unique characteristics are cr. . .
Should define what it is first… ie Bridging Validation is a run when one is trying to move from one. . .
KCAS provides dose form analysis (DFA) for clinical and non-clinical investigations, with a wide ran. . .
Flow cytometry is a technique used to detect and measure physical and chemical characteristics of a. . .
Fluorescence is used mainly for measuring compounds in solution, or in the case of flow cytometry, b. . .
Hybrid LCMS is a technique which combines an enrichment step (typically an antibody enrichment on be. . .
All biotherapeutics will need to undergo immunogenicity assessment sometime in their drug developmen. . .
Luminescence immunoassays use the low-temperature emission of light (as by a chemical or physiologic. . .
At KCAS, methods are developed with a fit-for-purpose design in mind, based on our Client’s needs. T. . .
Regulated clinical bioanalysis is a key focus at KCAS, supporting both human and animal health progr. . .
Non-clinical (or often referred to as preclinical studies) non GLP samples are often used for biomar. . .
PD Analysis is the assistance with design, regulatory requirements and final data interpretation. Of. . .
Biomarkers come in many favors. They can vary from serum/plasma analytes to the measurement of drug. . .
Pharmacokinetics (PK) is the determination of the extent of Absorption, Distribution, Metabolism and. . .
Polymeric conjugates are polymer backbones used as delivery systems for drugs conjugated to them. Po. . .
Size Exclusion Chromatography (SEC) is a chromatography method that allows for the separation of mac. . .
The analysis of a class of lipids referred to as glycosphingolipids (GSL’s). This class of lipids i. . .
Time resolved fluorescence (TRF) relies on the use of very specific fluorescent molecules called lan. . .
Tissue bioanalysis is an essential area in understanding the extent of drug distribution, metabolism. . .