Posts by Lindsay Rutherford, Ph.D.
Lindsay is currently a Senior Scientific Advisor at KCAS Bio, supporting Ligand Binding Assay (LBA) services. With more than 15 years of experience in assay development, she previously led the Large Molecule Method Development team at ICON. Prior to working in the CRO space, she spent a decade in diagnostics specializing in biomarker discovery and development. Her expertise spans the full spectrum of biomarkers and bioanalytical assay design. She received her Ph.D. in Chemistry at the University of Arkansas and works out of the Kansas City area.
Blogs
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…
Blogs
You might be asking what type of laboratory my biomarker assay requires or what level of qualification or validation my assay needs. These are complex questions which there continues to be a significant amount of misunderstanding around. Fortunately, KCAS Bio has extensive experience with both biomarker development and qualification/validation…
Blogs
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…
Blogs
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…