Research Phase - Clinical Development Solutions
All biotherapeutics will need to undergo immunogenicity assessment sometime in their drug development life cycle. Immunogenicity is analyzed in a tiered approach where samples are first screened, then confirmed, and finally characterized through quasi-quantitation and sometimes even domain specificity. Later in the clinical development of a biotherapeutic, it is also necessary to understand if the confirmed positive anti-drug antibodies are also neutralizing.
KCAS can help your clinical studies start on the right track
KCAS scientists have a wealth of experience in developing analytical method utilizing cells as an important reagent to explain the system biology. Our team of cell culture specialists have over 30 years of experience culturing and generating working cell banks for use in method development and validation of live cell methods.
KCAS Clinical Development 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…
Cell based assays are highly specialized in vitro methods that can evaluate the functional and…
Critical reagents are essential components of analytical methods whose unique characteristics…
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…
Regulated clinical bioanalysis is a key focus at KCAS, supporting both human and animal health…
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…
The Laboratory Collection Manual provides biological sample collection, processing, storage an…
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…