Bridging the Gap in GLP/GCLP Molecular Assay Validation with Automated Data Analysis Blogs
Read article Bridging the Gap in GLP/GCLP Molecular Assay Validation with Automated Data Analysis

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-blog-thumb_2024-011_ADA_Immunogenicity Assay Development Blogs
Read article The Critical Role of Immunogenicity in Drug Development: Why It Matters

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…

KCAS-blog-thumb_2024-010_Biomarker-Assay-Development2 Webinars
View webinar KCAS Bio Webinar- Biomarker Assay Development: Qualification Vs Validation Debate

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…

KCAS-blog-thumb_2024-04_Cyto Blogs
Read article Validation of Flow Cytometry Panels – Poster Presentation at CYTO2024

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…

PATTERN_BLUE_1320x780 Blogs
Read article Biodistribution Studies: Qualified vs. Validated Methods

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…

PATTERN_AMBER_1320x780_2 Blogs
Read article Understanding AAV Shedding in Tears: KCAS Bio’s Latest Study

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…

KCAS-blog-thumb_2023-08D_Soluble-Biomarkers Blogs
Read article Soluble Biomarkers: A Global Perspective on Bioanalysis

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…

PATTERN_AMBER_1320x780_3 Blogs
Read article Expanding Spectral Flow Capabilities with Cytek Aurora

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…

KCAS-blog-thumb_2023_01-B_Viral-Vectors-1 Blogs
Read article The Role of Bioanalysis in Viral Vector Development

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)…

KCAS-blog-thumb_2022_GLP-CGT Blogs
Read article The Role of GLP Toxicology Studies in Bioanalysis for CGT

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…

KCAS-blog-thumb_2022_Webinar-CGT-June-2022-1 Webinars
View webinar Upcoming KCAS Webinar (June 24th): “The Age of Cell and Gene Therapies is Upon Us – So What Does That Mean for Bioanalysis?”

Being produced by Xtalks on Friday, June 24, 2022 | 12pm EDT (NA) / 5pm BST (UK) / 6pm CEST (EU-Central) 60 min Webinar Description: Cell and gene therapies (CGTs) are types of treatment that use cellular or genetic material with the goal of treating a disease or a…