KCAS-event_2024-SOT March 10 - March 14

The Society of Toxicology’s annual meeting is just around the corner, and it’s shaping up to be an event you won’t want to miss. This year’s meeting will be held in Salt Lake City, Utah, from March 10th to 14th, 2024, and it promises to be an exciting gathering of…

PATTERN_ORANGE_1320x780 Webinars
View webinar KCAS Bio Webinar “Navigating the Complex Landscape of Lipid Panels & Small Molecule Biomarkers in Drug Discovery”

Produced by AAPS Organized by Sciex Recorded on December 6, 2023 eChalkTalk available here.  Webinar Description: In this webinar, scientists from KCAS Bio, along with specialists from SCIEX Biopharma & Pharma Solutions discuss • Developing robust assays for PD biomarkers and their challenges…

KCAS-blog-thumb_2023-09A_LBAs-Plethora Blogs
Read article Ligand Binding Assays: a Plethora of Technologies to Address Your Projects’ Requirements

Ligand binding assays (LBAs) have been our core activity for decades. LBAs are commonly used to measure interactions between two proteins, a ligand and its receptor, a monoclonal antibody (mAb) and its target, or biologics and Anti-Drug Antibodies (ADA). Throughout the development of New…

KCAS-blog-thumb_2023-07B_PK-ADCs Blogs
Read article Recent FDA Guidance for Pharmacokinetics and Antibody Drug Conjugates, and What They Mean for Your Projects at KCAS

With recent guidance released from the FDA, there are changes for PKs (Pharmacokinetics) and ADCs (Antibody Drug Conjugates) that must be clearly understood before making decisions for your drug product testing. ADCs combine the target specificity of monoclonal antibodies with the…

KCAS-podcast-thumb_TWB-067 Podcasts
Listen to podcast The Weekly Bioanalysis Podcast Eps #67: “Evolution of PK Modalities & the Impact on Regulations”

In the world of bioanalysis, pharmacokinetics is a key step in the process of measuring and identifying elements of the drug. It is a baseline for sample analysis, and in episode 67 of “The Weekly Bioanalysis”, Dom and John discuss the history and evolution drug and pharmacokinetic modalities…

KCAS-podcast-thumb_TWB-066 Podcasts
Listen to podcast The Weekly Bioanalysis Podcast Eps #66: “Recent Advances in Hybrid LC-MS/MS with Special Guests”

Special guests Dawn Duffield, PhD of KCAS and Barry Jones, PhD of Crinetics join John and Dom in the 66th episode of “The Weekly Bioanalysis” to discuss the ways Hybrid LC-MS/MS has advanced in recent years and how the technology has gone from “new” and somewhat obscure to…

KCAS-blog-thumb_2023-03_neuro-diseases Blogs
Read article Therapeutic Efficacy in Neurodegenerative Disorders​

Neurodegenerative diseases affect millions worldwide. Fifty million people are living with Alzheimer’s disease or other dementias. Although Alzheimer’s disease is one of the most recognized, it is just one of many neurological disorders, such as Multiple Sclerosis, Parkinson’s, or Huntington’s disease. These conditions lead to a…

PATTERN_AMBER_1320x780_3 Blogs
Read article The ICH M10 Guideline as the Gold Standard

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…

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…

KCAS-blog-thumb_2022_Paper-w-Gilead-Cyclodextrin-1 Blogs
Read article KCAS Bio and Gilead’s Joint Effort in SBECD Quantitation Assay Development

Dr. Sohrab Habibi Goudarzi – Senior Director of Pharma Discovery and R&D Services, Bryan Parmentier – Senior Principal Scientist of Pharma Method Development, and Yu-Hui (Ann) Fu -Principal Scientist of Pharma Regulatory, along with other scientists at KCAS Bioanalytical & Biomarker Services, coauthored with scientists at Gilead Sciences, Inc. in…