BIOPHARMACEUTICAL SERVICES

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. 

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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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Colorimetric analysis is a method of determining the concentration of a chemical element or chemical compound in a solution with the aid of a colorizing reagent. It is applicable to both organic compo. . .

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Should define what it is first… ie Bridging Validation is a run when one is trying to move from one methodology/set of parameters to another… etc.. Bridging validation is an essential when testing bio. . .

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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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Affinity capture elution (ACE) is a method used in detecting ADA to increase the assay drug tolerance. The method uses acid disassociation of ADA-therapeutic interaction to allow for preferential capt. . .

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Aggregate analysis is done to identify potential protein aggregation that can contribute to the overall purity profile of a biotherapeutic. Aggregates may form due to several reasons, including storag. . .

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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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Cell based neutralization assays encompass a variety of methods that can be utilized in the development of a drug and can include both neutralizing antibody methods or confirmation of the mechanism of. . .

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Cell based assays are highly specialized in vitro methods that can evaluate the functional and biochemical effects of a drug.  Biopharmaceuticals LBA Cell Culture Services allow for the complex study. . .

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

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Flow cytometry is a technique used to detect and measure physical and chemical characteristics of a population of cells or particles. Tens of thousands of cells can be quickly examined and the data ga. . .

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Fluorescence is used mainly for measuring compounds in solution, or in the case of flow cytometry, both on the cell surface & intracellularly. In fluorescence testing, both an excitation spectrum (the. . .

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Hybrid LCMS is a technique which combines an enrichment step (typically an antibody enrichment on beads or columns) with the selectivity and sensitivity provided by LC-MS/MS

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All biotherapeutics will need to undergo immunogenicity assessment sometime in their drug development life cycle.  Need to define what immunogenicity is.  Immunogenicity is analyzed in a tiered approa. . .

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Luminescence immunoassays use the low-temperature emission of light (as by a chemical or physiological process) and are a variation of the standard ELISA assay. There are many types of luminescence as. . .

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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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Neutralizing Antibody (NAB) Studies                             All biotherapeutics will need to undergo immunogenicity assessment. . .

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

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Non-clinical (or often referred to as preclinical studies) non GLP samples are often used for biomarker and pd (pharmacodynamics) assessments for drug development. In the case of ex vivo therapies and. . .

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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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Size Exclusion Chromatography (SEC) is a chromatography method that allows for the separation of macromolecules based on molecule size. This technique is useful in determining percentage of high molec. . .

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Time resolved fluorescence (TRF) relies on the use of very specific fluorescent molecules called lanthanides. These fluorescent molecules have the unusual property of emitting over long periods of tim. . .

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