Stream 3

Analytical & Quality


The weeklong Analytical & Quality stream offers perspectives on the most critical analytical and quality issues in product development, manufacturing and the safety of biologics. Leading industry and academic speakers will present strategies and case studies from early to late stage development in support of regulatory filings, and cutting edge tools for characterization of proteins stability. As part of this stream, a new conference on viral safety will discuss technical and regulatory aspects of detection, risk management of adventitious agent contamination coming from raw materials, cell culture processes, bioreactor and downstream processing.

Conferences Include:

August 3-4
Rapid Methods to Assess Quality & Stability of Biologics

August 5-6
Early Analytical Development for Biotherapeutics

August 6-7
Virus Detection, Clearance and Safety of Biologics