Journal of Bioequivalence & Bioavailability

Significance of stability studies for biosimilars

International Conference and Exhibition on Biowaivers & Biosimilars

September 10-12, 2012 Hilton San Antonio Airport, USA

Rajiv Dua

Posters: J Bioequiv Availab

Abstract:

To ensure product safety and efficacy, protein therapeutics must meet defined quality characteristics after manufacture as well at the end of their designated shelf lives. Many physical and chemical factors can affect the quality and stability of biopharmaceutical products, particularly after long-term storage in a container?closure system likely to be subject to variations in temperature, light, and agitation with shipping and handling. Compared with traditional chemical pharmaceuticals, proteins are considerably larger molecular entities with inherent physiochemical complexities. Proteins are typically sensitive to slight changes in solution chemistry. They remain compositionally and conformationally stable only within a relatively narrow range of pH and osmolarity, and many require additionally supportive formulation components to remain in solution, particularly over time. Even lyophilized protein products experience degradation. Advances in analytical chemistry have identified many degradation pathways that can occur in recombinant protein therapeutics over time. These pathways generate either chemical or physical instability. Contents: ? What is Stability??? ? Significance of Stability studies. ? Approach for Stability Testing. ? Types of stability studies and there trend analysis with case studies. ? Stability indicating methods. ? Stability guidelines we follow?. ? Supporting stability Studies with case studies. ? Temperature Excursion studies and its significance. ? Stability Study Management - Phases of Drug Development.

Biography :

Rajiv Dua holds Masters in Biochemistry and B.S (Chemistry Major) from university of Pune, India, In addition to that two post graduate diploma in Operations and Hospital/Healthcare management from symbiosis. More than 3.5 years of experience in biosimilar industry. His professional life started with Intas biopharmaceuticals R&D unit, India dealing with Analytical method development and Stability studies of biotherapeutic proteins. Currently functioning with Quality control department of Lupin Ltd, (Biotech Div.), He has authored one Research and couple of review articles on biosimilars and also holds a patent.