What is Immunogenicity Assessment? Immunogenicity refers to the ability of a substance, such as a New Biological Entity (NBE) or a vaccine, to provoke an immune response when administered in the body. The recognition of the substance as foreign triggers an immune response, which involves the production of antibodies and…

Along with a series of studies we plan to present related to our experiences with hybrid LC-MS/MS technology, KCAS will also be presenting on a study where we analyzed a compound that involved looking at urea in plasma and lung fluid (urea, of course, being a biomarker). Urea is endogenous…

For years, Dawn Dufield, PhD and I have been doing our best to get the word out (via as many venues as possible) about KCAS’s unique expertise with hybrid LC-MS/MS. This year’s upcoming EBF meeting in Barcelona is just such an opportunity, and one we are very much looking…

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…

In 2022 we had 42 FDA Drug Approvals and 3 were Gene Therapies using a viral vector.  2 of the approvals in 2022 were AAV based.  The third is manufactured by adding functional copies of the transgene to the patient’s own Hematopoietic Stem Cells (HSCs)…

Due to the relative maturity of the technology, most people’s instinct when thinking about bioanalysis of large molecules is towards ligand binding assays. However, we urge people to be open to a more flexible approach. Using hybrid LC-MS/MS can be an equally useful tool for quantitation of biological therapeutics and…

Tissue and Non-Liquid Matrices (such as cell lines, red blood cells, PBMCs, bone marrow aspirates, and suspension cells) are valuable matrices[] to test for biomarkers (PD) and drug levels (PK). Testing of tissues and…

To read part one of this 2-part series, click here. With increasing focus on large molecule therapeutics and interest in large molecule biomarkers it’s essential to have LC/MS available as a complimentary technology to ligand…

A recent trend in the pipelines of pharmaceutical companies & biotechs has been a shift to large molecule therapeutics. This presents a challenge for bioanalysis by LC/MS because the molecular weights of the target…

Protein characterization is a broad term describing the profile or fingerprint of a large molecule’s (or biologic’s) physical, chemical, and biological properties. Characterization of the protein will test the purity, activity, and the quantity…