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Discovery & Development Formulation, Quality & Compliance, Standards & Regulation, Bioprocessing - Upstream & Downstream, Technology and Equipment, Small Molecules, Bioprocessing - Single Use Systems, Technology and Equipment, Analytical Science

Therapeutic protein products used for the differentiation and characterization of subvisible particulates


The formation of protein aggregates is a particular concern for parenteral administration biopharmaceuticals due to the potential for increased immunogenicity. As a consequence, there is an expectation from regulatory agencies for companies to monitor and, if required, reduce the levels of sub-visible particles present in therapeutic protein from manufacture through their complete shelf life. While immunogenicity can be induced by a variety of mechanisms, contamination by non-protein material is known to be a potential cause. The presence of silicone oil in parenterals has attracted considerable interest, due to its use in syringe-based administration systems and the difficulty in distinguishing oil droplets from protein aggregates. In addition to protein aggregates, non-biological contaminants may act as nucleation points for aggregate growth. Consequently, particle sizing alone is not sufficient.

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  1. Guidance for Industry: Immunogenicity Assessment for Therapeutic Protein Products (2013): FDA
  2. Code of Federal Regulations; CFR21, Part211.65
  3. Characterization and Quantitation of Aggregates and Particles in Interferon-β Products: Potential Links Between Product Quality Attributes and Immunogenicity (2013): J. Pharm. Sci. (102) p.915
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