Characterizing and Minimizing Aggregation and Particle Formation of Three Recombinant Fusion-Protein Bulk Antigens for Use in a Candidate Trivalent Rotavirus Vaccine

In a companion paper, the structural integrity, conformational stability, and degradation mechanisms of 3 recombinant fusion-protein antigens comprising a non-replicating rotavirus (NRRV) vaccine candidate (currently being evaluated in early-stage clinical trials) are described. In this work, we foc...

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Veröffentlicht in:	Journal of pharmaceutical sciences 2020-01, Vol.109 (1), p.394-406
Hauptverfasser:	Agarwal, Sanjeev, Sahni, Neha, Hickey, John M., Robertson, George A., Sitrin, Robert, Cryz, Stanley, Joshi, Sangeeta B., Volkin, David B.
Format:	Artikel
Sprache:	eng
Schlagworte:	aggregation Antigens, Viral - chemistry Drug Compounding Drug Stability Drug Storage Drugs, Investigational - chemistry Excipients - chemistry formulation Freezing Particle Size Pharmaceutical Biotechnology Protein Aggregates Protein Stability Recombinant Fusion Proteins - chemistry recombinant protein rotavirus Rotavirus Vaccines - chemistry stability subunit vaccine Vaccines, Subunit - chemistry
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