Large Molecule Solutions
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 pre-clinical toxicology work, and clinical studies.
KCAS has an advanced team of Large Molecule specialists.
The approach of analyte capture and digestion or other sophisticated sample preparation techniques combined with LC-MS/MS is used to meet bioanalytical needs for large molecule drug discovery, preclinical, and clinical studies, including bioanalysis of proteins, antibodies, antibody-drug conjugates, biomarkers, and active endogenous compounds in biological fluids and tissues.
KCAS Large Molecule Services
Antibody drug conjugates (ADCs) remain a popular oncology therapeutic modality. ADC analyses r…
The translation of an assay from Discovery to Preclinical/Clinical is an important part of dru…
Colorimetric analysis is a method of determining the concentration of a chemical element or ch…
Should define what it is first… ie Bridging Validation is a run when one is trying to move fro…
Methods transferred into a new laboratory need to be re-established for regulatory compliance….
Affinity capture elution (ACE) is a method used in detecting ADA to increase the assay drug to…
Aggregate analysis is done to identify potential protein aggregation that can contribute to th…
Bioavailability (BA) is the percentage that a drug or its pro-drug form is absorbed into the g…
Cell based neutralization assays encompass a variety of methods that can be utilized in the de…
Cell based assays are highly specialized in vitro methods that can evaluate the functional and…
Regulated clinical bioanalysis is a key focus at KCAS. Our data has been used in the approval…
Critical reagents are essential components of analytical methods whose unique characteristics…
The accelerated pace within industry for quick “go / no-go” decisions in drug development, nec…
KCAS provides dose form analysis (DFA) for clinical and non-clinical investigations, with a wi…
Flow cytometry is a technique used to detect and measure physical and chemical characteristics…
Fluorescence is used mainly for measuring compounds in solution, or in the case of flow cytome…
Hybrid LCMS is a technique which combines an enrichment step (typically an antibody enrichment…
All biotherapeutics will need to undergo immunogenicity assessment sometime in their drug deve…
Clinical Sample Kits at KCAS are more than just clinical supplies for the collection of PK sam…
Luminescence immunoassays use the low-temperature emission of light (as by a chemical or physi…
At KCAS, methods are developed with a fit-for-purpose design in mind, based on our Client’s ne…
A fit-for-purpose approach is used by KCAS in method qualifications. Each method is designed t…
KCAS has extensive experience in validating methods in a wide range of bioanalytical platforms…
Multi-plex analysis of biomarkers is a powerful tool for screening of many analytes in a small…
Regulated clinical bioanalysis is a key focus at KCAS, supporting both human and animal health…
Non-clinical (or often referred to as preclinical studies) non GLP samples are often used for…
KCAS’ Kit preparation service can provide kits for  sample collection for Pre-Clinical/ Non-Cl…
The discovery phase in drug development requires rapid and reliable data in making key decisio…
PD Analysis is the assistance with design, regulatory requirements and final data interpretati…
Biomarkers come in many favors. They can vary from serum/plasma analytes to the measurement of…
Pharmacokinetics (PK) is the determination of the extent of Absorption, Distribution, Metaboli…
KCAS’ Clinical Sample Kit (CSK) service provides clinical sample kits for all phases of clinic…
The Laboratory Collection Manual provides biological sample collection, processing, storage an…
Biomarkers come in many flavors and can be used as alternatives for assessing the functionalit…
Size Exclusion Chromatography (SEC) is a chromatography method that allows for the separation…
Time resolved fluorescence (TRF) relies on the use of very specific fluorescent molecules call…
Tissue bioanalysis is an essential area in understanding the extent of drug distribution, meta…