Biologics are drugs derived from complex molecules like antibodies. Over the last two decades they have re-emerged as…
As with the lineup of equine subjects above, cell populations can take similar forms and act the same in a lot of ways – but to the trained eye, there are clear…
In the world of scientific research and development, certain analytes pose unique challenges that require specialized expertise to overcome. Oligonucleotides, a class of analytes consisting of short DNA or RNA sequences, are notorious for their complexity and demanding nature. With their increasing importance in the…
Business Wire – May 24, 2023 11:00 AM EST – In an effort to continue…
Clinical research carries significant risks and numerous obstacles that must be overcome to achieve success. Identifying the ideal Contract…
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…