Biopharmaceutical

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Affinity capture elution (ACE) is a method used in detecting ADA to increase the assay drug toleranc. . .

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Aggregate analysis is done to identify potential protein aggregation that can contribute to the over. . .

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The analysis of free amino acids (20 naturally occurring) in plasma or other biological matrices thr. . .

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Antibody drug conjugates (ADCs) remain a popular oncology therapeutic modality. ADC analyses require. . .

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The translation of an assay from Discovery to Preclinical/Clinical is an important part of drug deve. . .

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Cell based neutralization assays encompass a variety of methods that can be utilized in the developm. . .

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Cell based assays are highly specialized in vitro methods that can evaluate the functional and bioch. . .

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Regulated clinical bioanalysis is a key focus at KCAS. Our data has been used in the approval of ove. . .

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Colorimetric analysis is a method of determining the concentration of a chemical element or chemical. . .

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Critical reagents are essential components of analytical methods whose unique characteristics are cr. . .

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Should define what it is first… ie Bridging Validation is a run when one is trying to move from one. . .

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KCAS provides dose form analysis (DFA) for clinical and non-clinical investigations, with a wide ran. . .

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Flow cytometry is a technique used to detect and measure physical and chemical characteristics of a. . .

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Fluorescence is used mainly for measuring compounds in solution, or in the case of flow cytometry, b. . .

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Hybrid LCMS is a technique which combines an enrichment step (typically an antibody enrichment on be. . .

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All biotherapeutics will need to undergo immunogenicity assessment sometime in their drug developmen. . .

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Luminescence immunoassays use the low-temperature emission of light (as by a chemical or physiologic. . .

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At KCAS, methods are developed with a fit-for-purpose design in mind, based on our Client’s needs. T. . .

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A fit-for-purpose approach is used by KCAS in method qualifications. Each method is designed to achi. . .

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Methods transferred into a new laboratory need to be re-established for regulatory compliance.  The. . .

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KCAS has extensive experience in validating methods in a wide range of bioanalytical platforms.  Our. . .

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Neutralizing Antibody (NAB) Studies                  . . .

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Regulated clinical bioanalysis is a key focus at KCAS, supporting both human and animal health progr. . .

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Non-clinical (or often referred to as preclinical studies) non GLP samples are often used for biomar. . .

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PD Analysis is the assistance with design, regulatory requirements and final data interpretation. Of. . .

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Biomarkers come in many favors. They can vary from serum/plasma analytes to the measurement of drug. . .

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Pharmacokinetics (PK) is the determination of the extent of Absorption, Distribution, Metabolism and. . .

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Polymeric conjugates are polymer backbones used as delivery systems for drugs conjugated to them. Po. . .

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Size Exclusion Chromatography (SEC) is a chromatography method that allows for the separation of mac. . .

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The analysis of a class of lipids referred to as glycosphingolipids (GSL’s).  This class of lipids i. . .

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Time resolved fluorescence (TRF) relies on the use of very specific fluorescent molecules called lan. . .

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Tissue bioanalysis is an essential area in understanding the extent of drug distribution, metabolism. . .