Blogs
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…
Blogs
Immunogenicity, why do we keep talking about it? Immunogenicity can, in the simplest of terms, be described as a subject’s ability to generate antibodies specific to the dosed protein therapeutic. While stating it this way understates the complexity of the immune system and the methods needed to detect and characterize…
Webinars
Webinar Description: Biomarkers are a critical aspect of bioanalytical testing, as they provide a vast amount of information, from the effects of a drug on the subject to determining the drug’s mechanism of action and the correct dose for a patient. When developing a biomarker, it is important to understand…
Blogs
When you examine how to develop and validate/qualify a Biodistribution assay by PCR…
Blogs
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…
Blogs
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…
Blogs
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…
Blogs
A biomarker is a defined characteristic that is measured as an indicator of normal biological processes, pathogenic processes, or biological responses to an exposure or intervention, including therapeutic interventions(1). With the development of innovative and personalized therapies, biomarker tracking is increasingly important to support the clinical development…
Blogs
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…
Blogs
ICH M10 (International Committee of Harmonization Multidisciplinary guideline) provides guidance on bioanalytical method validation and study sample analysis for the measurement of chemical and biological human drugs and their metabolites in biological samples. Such pharmacokinetic/toxicokinetic data serve as the basis for regulatory decisions on the safety, dosage, and…
Blogs
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)…
Blogs
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…