Posts by Lindsay Rutherford, Ph.D.

Lindsay is currently a Scientific Advisor at KCAS Bio, supporting Ligand Binding Assay (LBA) services. Lindsay has over 15 years of experience in assay development and previously worked at ICON overseeing the Large Molecule Method development team. Prior to her CRO work, Lindsay spent 10 years in the diagnostic and drug development space. She received her Ph.D. in Chemistry at the University of Arkansas and works out of the Kansas City area.

LBA Assays Blogs
Read article The Singlet vs. Duplicate Sample Analysis Dilemma for support of LBA assays

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…

KCAS-blog-thumb_2024-Considerations Blogs
Read article Considerations During Bioanalytical Biomarker Development

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 to…

PATTERN_BLUE_1320x780_3 Blogs
Read article Overcoming Challenges in Bioanalytical Method Transfers

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…

KCAS-blog-thumb_2023-07B_PK-ADCs Blogs
Read article Recent FDA Guidance for Pharmacokinetics and Antibody Drug Conjugates, and What They Mean for Your Projects at KCAS

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…