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Meeting biopharmaceutical analytical requirements for subvisible particle sizing and counting

22 October 2015  •  Author(s): John Carpenter, University of Colorado / Amber Haynes, Fradkin KBI Biopharma / Christina Vessely, Biologics Consulting Group Inc.

Quantifying and sizing subvisible particles in biopharmaceutical products are crucial aspects of formulation development, stability studies, process development, product release and extended characterisation of the final drug product. The particles, which may consist of aggregated proteins, and/or components shed from process materials or container closure systems, can directly impact on the efficacy and immunogenicity of a drug product. Also, they often act as nucleation sites for further protein aggregation and/or lead to the development of larger particles by agglomeration. Measuring the size and concentration of subvisible particles within a formulation is an essential precursor to their effective control, and of growing importance as the industry works towards ‘zero defect’ and ‘essentially particle-free’ products. In this article we consider requirements for subvisible particle measurement within the context of current regulatory expectations, and more broadly, review the technology available to meet them.

Subvisible particle sizing and counting

Analytical instrumentation for the biopharmaceutical industry continues to develop to meet evolving needs, and new tools are being commercialised on a regular basis. Such innovations allow researchers to use orthogonal techniques for subvisible particle characterisation and to gain the insight needed to formulate safe, stable and effective products.

Investigating the impact of subvisible particles

Subvisible particles are usually defined as being in the size range 0.1μm to 100μm, often above the upper size limit for measurement by sizeexclusion chromatography but not sufficiently large to be detectable by eye. Such particles may be proteinaceous (aggregates or proteins adsorbed onto other contaminants), silicone oil from the syringes, devices and stoppers used during drug delivery, or other contaminants arising from either the manufacturing or drug delivery process.

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