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Effect Of Agitation On Protein Aggregation In Vials Made From Glass Or Plastics, Birgit Mueller-Chorus, Erica Tullo, Vinod Vilivalam, Lloyd Waxman

Single-use Technologies II: Bridging Polymer Science to Biotechnology Applications

The increasing use of proteins as therapeutics including monoclonal antibodies has focused attention on the need to maintain the stability of these labile molecules during both storage and shipment. The degradation of therapeutic proteins can arise from aggregation and adsorption in primary containers, as well as from exposure to leachables, and chemical damage due to exposure to oxygen or light. Since vials continue to be used as primary containers for multiple-use applications, including vaccines and lyophilized drug products, we have compared the effect of mechanical stress on protein aggregation in vials made of glass versus vials made of the plastic …