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The biopharmaceutical shift within the drug development industry has focused increasing attention on the behavior of biological molecules in the formulation. Aggregation of proteins is key to formulation and stability assessments, with a recent interest in the 100nm - 1µm aggregate size range, identified as an area of concern for immunogenicity and therefore product safety.
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Protein aggregation characterization is key to successful biopharmaceutical development and manufacturing. Protein aggregates can form at any stage of the development or manufacturing process including bioprocessing, purification, formulation, and packaging, and also during storage.
Protein aggregates can be considered an impurity, or a molecular variant, resulting from changes that take place over time and/or by the action of physical factors such as light, temperature, pH, water, shear-forces, or by reaction with an excipient in the formulation, concentration of buffers or interaction with the container/closure system. Aggregates include reversible non-covalent and irreversible covalent bonded species, dimers, oligomers, and higher multiples, of the desired protein product and can be present as small soluble particles ranging in size from a few nm to large sub-visible/visible particles up to microns.
Aggregation of a protein therapeutic can have serious implications for patient safety, biologic product stability, potency, biological activity, quality, and efficacy. As aggregation has been reported to lead to adverse immune reactions in patients, it is important to mitigate health risks during drug development through a comprehensive understanding of your biomolecule’s propensity to aggregate and characterization of the aggregation state.
While Dynamic Light Scattering (DLS) is used to detect the polydispersity (size spread) of biopharmaceutical formulations, Size Exclusion Chromatography (SEC) products are able to separate particles present in samples by size and enable the quantity of oligomerization to be measured.
Nanoparticle Tracking Analysis (NTA) also provides accurate, reproducible analysis and visualization of particles such as protein aggregates in formulation, in the size range of 50nm to 2000nm diameter. Enabling the fluorescence mode allows specific analysis of labeled or intrinsically fluorescent particles.
Measurement of these parameters can provide valuable information on the suitability of a product formulation and may also give an indication of the stability and prospective shelf-life of a product.
Depending on your requirements and/or position on the development pipeline, we provide suitable solutions on issues around protein aggregation, thus ensuring your product achieves the desired stability and efficacy.