Over the past decade, a continued discussion point has been the idea around analyzing samples on Ligand Binding Assay (LBA) platforms in singlet (one well) versus the standard duplicate analysis (Single sample added to two different wells). In the recent M10 Bioanalytical Method Validation Guideline issued for guidance in June…

Immunoassays are bioanalytical methods that generally use antibodies to detect and quantify specific analytes, often proteins, in biological samples. The process involves the capture of a target protein by an immobilized antibody, followed by its detection with another antibody conjugated either to enzymes, such as phosphatase alkaline or horseradish peroxidase…

KCAS is a rapidly growing industry leader that continues to increase its vast knowledge surrounding assay transfers not only internally but externally as well.  As KCAS expands as a global leader in the bioanalytical space we have taken our knowledge surrounding internal assay transfers and extended that knowledge to external…

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…

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

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…