Pharmaceutical Services

Discovery: In the discovery phase of the drug development pipeline, new drug molecular structures, delivery mechanisms, or simply ideas will be too many to see through every single one of them. The Discovery Group is focused on providing fast turnaround times to testing our clients’ research ideas.
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. 

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Antibody drug conjugates (ADCs) remain a popular oncology therapeutic modality. ADC analyses require complex bioanalytical strategies to ensure complete pharmacokinetic and immunogenicity data is accu. . .

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The translation of an assay from Discovery to Preclinical/Clinical is an important part of drug development. It requires an understanding of the context of use of the assay, as well as, the robustness. . .

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Methods transferred into a new laboratory need to be re-established for regulatory compliance.  The extent to which an assay has to be re-validated varies, however, most methods necessitate full valid. . .

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The analysis of free amino acids (20 naturally occurring) in plasma or other biological matrices through derivatization and UPLC-MS/MS.

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Bioavailability (BA) is the percentage that a drug or its pro-drug form is absorbed into the general circulation. BA is calculated by comparing the blood concentration profile of test article given in. . .

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A significant number of drugs contain a chiral center that allows the compound to properly fit into an active site for optimum pharmacologic effect. Therefore, assays capable separating the isomers ar. . .

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Regulated clinical bioanalysis is a key focus at KCAS. Our data has been used in the approval of over 300 drugs over our 40 years of operation.

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Critical reagents are essential components of analytical methods whose unique characteristics are crucial to assay performance.  The 2018 FDA Bioanalytical Method Validation Guidance for Industry spec. . .

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The accelerated pace within industry for quick “go / no-go” decisions in drug development, necessitates laboratories to be able to meet timely results.

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KCAS provides dose form analysis (DFA) for clinical and non-clinical investigations, with a wide range of excipients potentially present.

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At KCAS, methods are developed with a fit-for-purpose design in mind, based on our Client’s needs. This can range from developing an assay in support of a proof-of-concept to a GLP-compliant investiga. . .

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A fit-for-purpose approach is used by KCAS in method qualifications. Each method is designed to achieve not only a client’s objectives but budgetary constraints.

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KCAS has extensive experience in validating methods in a wide range of bioanalytical platforms.  Our methods are designed to meet regulatory compliance with FDA, EMA, Health Canada and can meet guidel. . .

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

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The discovery phase in drug development requires rapid and reliable data in making key decisions for investigations that may range from proof-of-concept to drug candidate selection. Therefore, the cri. . .

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PD Analysis is the assistance with design, regulatory requirements and final data interpretation. Often it can be the difference between the success and failure of a drug. The ever increasing relevanc. . .

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Biomarkers come in many favors. They can vary from serum/plasma analytes to the measurement of drug pathways. KCAS can assist with your biomarker needs in a variety of ways.

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Pharmacokinetics (PK) is the determination of the extent of Absorption, Distribution, Metabolism and Excretion (ADME) of a Small Molecule compounds, peptides, and Biologics/Large Molecules.   KCAS can. . .

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Polymeric conjugates are polymer backbones used as delivery systems for drugs conjugated to them. Polymeric conjugates may also be fusions with  proteins or peptides fused with a polymer (such as PEG). . .

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The extent to which a drug binds to plasma proteins can range from neglible to 99.9+% with compounds such as warfarin. Drugs with high protein binding fractions can have significant impact, if co-admi. . .

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Pharmacological activity of a drug molecule is influenced by many factors.  The way a molecule is metabolized can affect the safety of the drug and its efficacy.  The identification of those metabolit. . .

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