Biologics with a difference
Sarah E Lee
Baxter Healthcare, USA
: J Pharm Drug Deliv Res
Abstract
As biologics continue to evolve, the delivery platform/method plays an increasingly critical role. In parallel, clinical guidelines are also calling for increased safety and simplicity in medication delivery. Due to complexity related to heat-intolerance, biologics requiring intravenous dosing are typically reconstituted just prior to use. Aseptic-filling is a method which does not involve the use of heat for sterilization, and is a proven sterilization approach for commercial-scale filling of biologics and other heat-sensitive molecules. Baxter’s R&D scientists have performed stability, oxidation and agitation studies including the evaluation of aggregation and bioactivity for two monoclonal antibodies and a therapeutic protein (hormone). Data will be presented that demonstrates compatibility of biologics in an aseptically-filled, flexible IV container using Baxter’s proprietary process/technology. This process/technology in flexible IV container presentation for biologics and other heat-sensitive molecules is exclusive to Baxter. The presentation is intended to demonstrate the science behind delivering biologics with a difference.
Biography
