Systems Serology Applications

Systems Serology Applications

Systems Serology is a versatile platform that 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

Downstream of correlates, Systems Serology supports the 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? 

For Immunotherapies

DISCOVERY

What function or mix of function correlates with therapeutic efficacy of  immunotherapies including monoclonal therapeutic antibodies?

LEAD SELECTION

What product construct best delivers the desired mix of function?

MANUFACTURING
SCALE UP

Does therapeutic product biophysical and functional quality stay the same during process development?

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