The bioanalysis world has exploded with the need for molecular assays (qPCR, dPCR, NGS, Hybridization technologies) due to the demand for both biodistribution/PK and PD/BM analysis of various drug modalities. Many of these molecular assays have been around for decades and are now routine methods. CLIA and reference labs have…

KCAS Bio is attending CYTO2024, the 37th annual Congress of the International Society for the Advancement of Cytometry in Edinburgh, Scotland! A great occasion to explore the latest advancements in cytometry science and to discuss our flow cytometry services with the community. At this edition, Alessandra Roberto, PhD…

In the ever-evolving landscape of pharmaceutical research, biodistribution studies play a pivotal role in understanding how drugs and therapies are distributed within the body. These studies are critical for assessing the efficacy and safety of new treatments, particularly in the realm of cell…

Recently, Matthew Pennington, PhD (one of KCAS’s Senior Scientists) was the senior author on a publication entitled “A Validated Droplet Digital Polymerase Chain Reaction Assay for the Detection of Adeno Associated Viral Vectors in Bio Shedding Studies of Tears”. Below, Matt explains the significance in what they accomplished…

Spectral flow has come a long way in recent years, transforming from a mere whisper of possibility to an essential tool in bioanalysis. Initially gaining traction in academic institutions, it quickly caught the attention…

In 2022 we had 42 FDA Drug Approvals and 3 were Gene Therapies using a viral vector.  2 of the approvals in 2022 were AAV based.  The third is manufactured by adding functional copies of the transgene to the patient’s own Hematopoietic Stem Cells (HSCs)…

Cell and Gene Therapies (CGTs) has an estimated market size value in 2022 of USD 8.22 billion and a revenue forecast in 2030 of USD 24.5 billion. This is a CAGR (compound annual growth rate) of 14.6% from 2022 to 2030. Needless to say, the…

Assay validation is required during the development of new drugs or biologics in order to be in compliance with regulatory requirements for all studies that are not considered research/exploratory in nature. Beyond compliance, what is the point of assay validation? Assays must be precise, robust, and specific during use in preclinical studies and clinical trials in order to assure that drug candidates can be accurately evaluated for safety and efficacy. Validation plans assure that an assay will work reliably, even if an assay is run at different sites or by different users. Consider these other elements of assay validation to understand why it is a critical to preclinical and clinical research:   Fit-for-purpose strategy: Each validation plan determines if an assay is made to be fit-for-purpose for a given client’s evaluation needs. Assays can be customized to meet the specific needs of a preclinical screening or clinical trial and fit-for-purpose validation assures that reliable data can be obtained from assay. Test scripts: Test scripts are a series of procedures to be executed during a validation in order to determine if an assay satisfies the necessary specifications or to reveal errors that must be addressed. Running test scripts is essential to the development and continued reliability of a validated assay. GLP compliance: Assay validation must be carried out under the same conditions as will be used for routine assay use. Good laboratory practices (GLP) conditions are needed for many preclinical and clinical applications, and routine quality assurance/quality control monitoring may also be necessary. Be aware of these special circumstances during assay validation. Validation is so much more than a regulatory hurdle. Validation gives you confidence that an assay will yield reliable results that can be trusted to make critical decisions for advancing drug candidates or evaluating clinical efficacy.

Flow cytometry has been developed and used as a clinical tool since the invention of the first cytometers in the 1970s. At present, flow cytometry is considered essential for many routine clinical diagnostics, including assays for leukemia and lymphoma, stem cell enumeration, solid organ transplantation, HIV infection status, immunodeficiencies, and hematologic abnormalities. Many scientists involved in clinical trials or drug development are faced with developing clinical flow cytometry assays for multiple phases of clinical development. If you find yourself starting to plan a clinical flow cytometry assay, here are the top 3 issues to think about as you plan your experiment.