Ulrike Konrad
Protagen Protein Services, Germany
Title: CMC considerations for biosimilar drug development
Biography
Biography: Ulrike Konrad
Abstract
Developing a biosimilar from a CMC perspective is a scientific and risk based approach and not a list with checkboxes to be ticked off. Following the quality strategy, the biosimilarity cannot be tested in the clinical trials but must be demonstrated on the drug substance and product level. For this, there are typical road maps always starting with a quality target product profile of the originator molecules. This talk will focus on typical analytical modules on the road map also touching the comparison of degradation profiles and impurities of biosimilar and originator molecules in a side-by-side analytical situation. All that must be adapted to the company’s strategy for market, time for development, budget and partners. Typical examples will be presented combined with pitfalls that companies are facing during the development.