Our hosts, Dom and John, are excited to welcome special guest, Carrie Vyhlidal, to discuss the topic of the 80th episode of “The Weekly Bioanalysis” podcast – The Rapid Evolution of PCR Assays. PCR (or Polymerase Chain Reaction) is like a copying machine for DNA. Scientists have found ways…
The most recent episode of “The Weekly Bioanalysis” podcast is all about genes! The topic was originally inspired by an article entitled “The Coming of Age of One-and-Done Therapies” which jumped out to both of our hosts, Dom and John, and had been on the back burner for a…
KCAS Bio is excited to announce our participation in the annual congress of the French Society for Toxicology, taking place on November 14-15 at the Lyon Convention Center. This landmark event, celebrating the 50th anniversary of the French Society of Toxicology will focus on “Evolutions, Innovations, and New Trends…
Dom and John welcome special guests, Habibi Goudarzi and Rochelle Burke to episode #77 of “The Weekly Bioanalysis”, where they discuss the progression of bioanalytical needs for non-GLP Studies, from Early PK to readiness for GLP Tox Studies. These specialists from the KCAS Bio team begin with an introduction…
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…
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…
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…
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…
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…
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…
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…