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…

Dom and John discuss the role early non-clinical bio analysis plays in your project, why it is important, how it has changed over the years, and what might be next for this growing part of the industry. To view/listen to the episode of “the Weekly Bioanalysis” click the…

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…

Being that it is a relatively “niche” segment of the industry, there are several key areas that need to be considered in the field of molecular services related to cell and gene therapies. First and foremost, it is important to recognize that regulatory guidelines within this field are…

Anyone who has been following KCAS for any amount of time has likely heard us discuss the advantages of Hybrid LC-MS/MS for the bioanalysis of large molecules. As pioneers in the technology for many years, KCAS has become a strong proponent of working with our customers to demonstrate the quality…

Understanding the interactions between drugs and biological systems is critical for the success of a new drug. One key tool in this process is functional assays. Functional assays are customized assays that evaluate the impact of drugs on the functionality of cells. They test for a drug’s specific biological mechanism…

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)…

With 2022 firmly planted in our rearview mirror, and the planning for the new year essentially complete, we all look forward to a new year with cautious optimism as we wait to…

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…

Dose Formulation Analysis is an essential step in regulated nonclinical studies. Robust analytical methods, rapid turnaround, and efficient communication helps deliver your GLP studies’ dose formulation analysis results on time…