February 21, 2022

NASH, NAFLD, & NIS4: Ask an Expert with Marge Connelly

Dr. Margery Connelly is the lead scientist behind several Non-Alcoholic Fatty Liver Disease (NAFLD) and Non-Alcoholic Steatohepatitis (NASH) tests at Labcorp, as well as testing for other metabolic disorders. Dr. Connelly discusses the clinical significance of NASH and what positive NASH and liver fibrosis test results mean for patients.
June 6, 2023

Released N-glycan analysis of the Fc-fusion protein aflibercept with additional site-specific population and occupancy

Glycosylation is a common post-translational modification of monoclonal antibodies (mAbs) located on a specific asparagine amino acid site, N297. Many glycan variants exist; however, they all share a core structure of two N-acetylglucosamine residues and three mannose residues. A mAb is likely to have two different glycan species attached (glycan pairs), with one on each heavy chain, which means an astounding number of glycoforms, or mAbs with different glycan pairs, can exist. It is imperative to monitor these species, as they can impact patient safety and alter the properties of proteins, such as pharmacokinetics / pharmacodynamics (PK/PD), solubility, stability, and effector functions.
September 30, 2024

Forced degradation of biopharmaceuticals protein stress testing

Forced degradation is defined as the intentional degradation of a biotherapeutic to an appropriate extent by means of various stressing agents. The overall aim of such forced degradation (also known as stress studies) is to understand how a biotherapeutic may undergo degradation, whether this occurs during or following manufacture. More specifically, forced degradation aims to accelerate the chemical and physical changes of a biopharmaceutical molecule in order to determine the mechanisms of degradation depending on the various stresses applied to it.
September 30, 2024

Why cell line screening is crucial for successful complement-dependent cytotoxicity (CDC) assay development

One of the major improvements in oncotherapy of late has been the development of monoclonal antibodies (mAbs) targeting tumor-specific antigens. The ability of these antibodies to kill tumor cells is largely dependent on their Fc effector function. While the complementarity-determining region of the molecule binds the specific tumor antigen, the Fc portion induces target-cell killing by three main mechanisms: complement-dependent cytotoxicity (CDC), antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP). Fc effector functionality is a critical area to assess for mAb therapeutics, and cell-based potency assays are used for QC batch release and biological characterization.
September 30, 2024

Setting the foundation of success in your drug development

The primary function of biopharmaceutical development is to demonstrate that the investigational drug is both safe and efficacious for human use. And aspect of this is to have a comprehensive understanding of both the drug substance and drug product, both from a physiochemical and biological viewpoint. Accordingly, there is a regulatory expectation that any investigational biopharmaceutical will be thoroughly characterized using a wide range of analytical techniques. Due to the highly complex nature of biopharmaceuticals, this is not a trivial exercise, often involving orthogonal analytical techniques to gain deep understanding of the biopharmaceutical product. In this brochure, we outline the regulatory expectations for biopharmaceutical characterization along with the specific requirements for some of the more common modalities that are currently in development.
<span>Identifying and treating inflammatory bowel disease</span>
December 16, 2024

Identifying and treating inflammatory bowel disease

The first week of December marks Chron’s and Colitis Awareness Week. This is when we annually observe and raise awareness for the approximately 3 million people living with inflammatory bowel disease (IBD), the collective term for Crohn’s disease and colitis. Chron’s disease is inflammation of the gastrointestinal tract anywhere from the mouth to the anus, while colitis is inflammation of the colon/large intestine. Both conditions attack the digestive system and are medically incurable, but they can be managed to lessen their impact.