Peptide Mapping by LC-MS: A Multi-Attribute Method for the Characterization of Therapeutic Proteins
23rd July 2018
Category: Bioanalytical
Tags: LC-MS, peptide mapping, QbD
By: Dr Martin De Cecco - Senior Scientist,
A hot topic in the field of biopharmaceutical analysis is the concept of a multi-attribute method (MAM)¹, i.e. the characterization of several different product quality attributes with a single assay. The appeal to developers of biotherapeutics is clear: more information from a smaller number of tests. Such an approach is in keeping with the principle More
The Impact of Human Serum on ADCC Assays
3rd July 2018
Category: Bioanalytical
Tags: ADCC assay, biosimilar development
By: Laura McAleer, PhD - Senior Scientist, Product Development,
Antibody-Dependent Cellular Cytotoxicity (ADCC) is a mechanism adopted by the immune system to remove infected or cancerous cells. Antibodies bind a specific antigen on the target cell surface, which in turn binds the FcγRIIIa receptor on effector cells (e.g Natural Killer (NK) Cells) via the Fc region, resulting in the lysis of the target cell. Although in More