Systems Serology Applications
Systems Serology Applications
Antibody polyfunctionality assessment using the versatile System Serology platform links antibody structure with antibody function with clinical outcome. It is being used along the drug development process from discovery to development and to support regulatory filings, as a clinical trial endpoint or to demonstrate product comparability.
For Vaccines
DISCOVERY
Identify the mechanistic correlates associated with natural disease (recovery/convalescence) or protection by vaccination.
LEAD SELECTION
Development of vaccine design strategies (e.g., prime/boost, dose and timing, formulation assessment including adjuvants)
ASSAY DEVELOPMENT, QUALIFICATION, VALIDATION
Which assays need to be demonstrated to be statistically robust so that data from them can be included in regulatory filings?Â
For Immunotherapies
DISCOVERY
What function or mix of function correlates with therapeutic efficacy of immunotherapies including monoclonal therapeutic antibodies?
MANUFACTURING
SCALE UP
Does therapeutic product biophysical and functional quality stay the same during process development?
