From the Agenda

CMC Considerations for Biosimilar Drug Development

2017-11-23 14:30

Ulrike Konrag

Business Development Manager

Ulrike Konrad has gained more than 10 years of experience in Biotech/Pharma with focus on protein analytics and biosimilar development to reach and demonstrate biosimilarity.
She graduated in chemistry at the University in Heidelberg/Germany and finished two years later her Master of Business Administration. She has worked as project manager in different Biotech companies and joined Protagen Protein Services in 2012.
In her role, she has supported numerous biosimilar developments including the consulting for the analytical and regulatory strategy for Europe, USA, India, Korea, Brazil and Mexico.
Ulrike represents PPS as a speaker at several International Biosimilar conferences

Protagen Protein Services GmbH (PPS) is a leading CRO for Protein Analytics of Biotherapeutics.
The long experience in business (since 1997), 80 protein analytical specialist and the comprehensive, GMP compliant spectrum of state of the art analytical methods ensure the highest quality in the field of pharmaceutical, biotech, and the entire life science industry.
Besides new biological entities (NBE) including ADCs, PPS is currently supporting 25 Biosimilar Developers in all stages of Biosimilar developments targeting 30 different Reference Molecules.
Data generated at PPS is already accepted by EMA, FDA, and many other agencies for scientific advices, phases1 to 3, MA and release testing.