Oncobiologics expound on biosimilar CMC in New Jersey this November
Principal Scientist Hiten Gutka will discuss considerations for drug product and formulation development. The presentation will focus on excipient quality and influence on biosimilar drug product quality and stability, as well as container closure effect on stability of the biosimilar.
Rajani Srikakulam, also a Principal Scientist, will present a session on functional similarity assessment which talks about the importance of functional assays/bioassays in biosimilar development and why they are as important as in-depth structural characterization. The talk will also discuss how to select appropriate bioassay methodologies as well as tiering of functional attributes based on mechanism of action and known clinical relevance.
Hiten and Rajani join a speaker line-up comprised of experts shaping up the biosimilars landscape in North America including representatives from Sandoz, Harvest Moon Pharmaceuticals, Momenta, FUJIFILM Diosynth, Pfenex, Adelio, Covance, Zuckerman & Spaeder and more.
The full roster of speakers and their topics can be found on www.biosimilars-
SMi's Biosimilars North America conference will explore significant developmental topics within the sector including the impact of FDA's newly implemented biosimilar interchangeability guidelines, the US market access landscape, and biosimilars of orphan drugs.
Registration is now live on the event website and there For more information visit www.biosimilars-
4th Biosimilars North America
November 15 & 16, 2017
Renaissance Woodbridge Hotel, Iselin, NJ, USA
--- END ---
About SMi Group:
Established since 1993, the SMi Group is a global event-production company that specializes in Business-to-