The development and commercialization of biopharmaceutical products is paving the way for significant growth in the pharmaceutical industry. Virtual and small biotech companies are researching and developing new biotechnology-based products that help large pharmaceutical companies backfill their pipelines. Many of these products have been in development for years and are finally reaching the point of commercialization. Because of the nature of many of these substances, they are sensitive to their environment, their packaging and their delivery systems…
Tag: <span>aggregation</span>
The biologic activity of protein therapeutics is often compromised by the formation of soluble aggregates and protein precipitates. While the detailed molecular mechanism of protein aggregation remains unclear, substantial evidence suggests that factors that promote protein unfolding and exposure of hydrophobic residues play a significant role in aggregate formation. These can vary according to the particular protein of interest, the solvent system, and storage conditions. Slight changes in temperature, pH, and ionic strength have been documented to have a significant effect on the aggregation phenomena of numerous proteins. Freezing and subsequent thawing of a preparation (whether by design or accident) during processing, shipping, and storage can induce subtle changes in the ionic strength, solute concentration, and pH of a given preparation and induce aggregate formation…