Yvette Stallwood
Lonza Biologics, UK
Title: Predicting, avoiding and mitigating risk of failure when developing biotherapeutics
Biography
Biography: Yvette Stallwood
Abstract
This presentation will discuss how in silico and in vitro methodologies are employed to perform a developability and immunogenicity risk assessment in order to highlight potential risks of failure for the development of biotherapeutics. In silico methods can be used to evaluate protein sequence and structure to assess the likelihood of immunogenic responses and potential manufacturability issues including aggregation and PTMs. Ex vivo T and B-Cell responses enable the assessment of overall immunogenicity risks; different approaches are highlighted to further identify processed and presented epitopes.