Cell & Gene Therapy Solutions
Whether you are working on cell therapies, gene therapies, or a combination of cell and gene therapies, KCAS, along with our newly acquired FlowMetric and Active Biomarkers, have you covered. With extensive technological advances like CRISPR and CAR-T, cell and gene therapy has become a viable way to treat cancer and other diseases. KCAS provides bioanalytical services using complementary bioanalytical platforms to be your partner in all phases of the development of your cell and gene therapy programs including biomarker, immunogenicity, PK/PD, shedding, and cell-based assays.
KCAS can support your Cell and Gene Therapy project
Our team has over 100+ years of combined experience in molecular services using qPCR and ddPCR to support pre-clinical and clinical trials in various species and matrices. Our new state-of-the-art facility has a unidirectional workflow with two dedicated preamplification areas and a dedicated post-amplification area to support molecular services.
KCAS Cell & Gene Therapy Services
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….
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…
Cell based assays are highly specialized in vitro methods that can evaluate the functional and…
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…
Flow cytometry is a technique used to detect and measure physical and chemical characteristics…
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…
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…
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…
Tissue bioanalysis is an essential area in understanding the extent of drug distribution, meta…