Biologics are drugs derived from complex molecules like antibodies. Over the last two decades they have re-emerged as…

In recent years, immunology…

Business Wire – May 24, 2023 11:00 AM EST – In an effort to continue providing the…

Clinical research carries significant risks and numerous obstacles that must be overcome to achieve success. Identifying the ideal Contract…

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…

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…

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…

Due to its ability to analyze multiple parameters across different cell types within a sample, flow cytometry provides rich and clinically valuable data sets from even small volumes of blood. However, flow cytometry is a challenging platform to master, and requires significant investment in equipment and technical training.

After an open call that went out earlier this year, Shane De Büchel, Sr Manager of Quality Assurance (Compliance & Systems) at KCAS, has been selected as one of roughly 50 members of the Society of Quality Assurance to collaborate in authoring an upcoming data integrity book (the…

With the extensive advances in technologies like CRISPR and CAR-T, cell and gene therapy has grown to become a viable way for treating Cancer as well as other diseases. Our team has over 100+ years of collective expertise in molecular services using qPCR and ddPCR for support of…

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…