All biotherapeutics will need to undergo immunogenicity assessment sometime in their drug development life cycle. Immunogenicity is analyzed in a tiered approach where samples are first screened, then confirmed, and finally characterized through quasi-quantitation and sometimes even domain specificity. Later in the clinical development of a biotherapeutic, it is also necessary to understand if the confirmed positive anti-drug antibodies are also neutralizing.
KCAS scientists have a wealth of experience in developing analytical method utilizing cells as an important reagent to explain the system biology. Our team of cell culture specialists have over 30 years of experience culturing and generating working cell banks for use in method development and validation of live cell methods. We know how to build and manage a cell bank to ensure that proper passage number of cells are optimized for the cell based method. We can transfer a method and if needed optimize the method to meet regulatory requirements.
KCAS has a dedicated, isolated cell culture suite to dramatically reduce the change in potential contamination of the cell during culture and processing. We have multiple tools to assist us in choosing the most appropriate output for your assay, whether that be flow cytometry, imaging, cAMP readouts, etc.