Neil Schauer
Schauer Biologics Consulting LLC, USA
Title: Risk based development and manufacturing of biosimilars
Biography
Biography: Neil Schauer
Abstract
The development of biosimilars presents a unique risk profile to biopharmaceutical companies when compared to proprietary biologics development. This risk profile will be examined and used to explain why biosimilars must be developed and manufactured differently than originator molecules, in order to insure commercial success. For biosimilars, commercial
endpoint oriented process development should start earlier for biosimilars than for originator products. To buy down risk, at-scale manufacturing may be desirable as early as nonclinical / phase I manufacturing.