Challenges in the development of high protein concentration formulations.

By S. Shire, Z. Shahrokh, Jun Liu. Journal of Pharmacy and Science, 2004

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Design of therapeutic proteins with enhanced stability (2009, background): “One of the major problems encountered in antibody-based therapies is that these antibodies tend to aggregate under the high concentration formulations required for disease treatment (3).”
Protein aggregation: pathways, induction factors and analysis. (2009, methodology): “Furthermore, altering the protein concentration through dilution could cause the dissociation of reversible aggregates.(69,124,125) Other potential sources of error in DLS include temperature fluctuations, measurement duration, sample’s rheological properties, protein concentration range, irregular ”
Formulation and manufacturability of biologics. (2009, background): “However, the emergence of monoclonal antibody therapies for home-use, subcutaneous (SC) administration, has necessitated the development and manufacture of high concentration formulations >100 mg/mL [4 ].”
Protein drug stability: a formulation challenge (2005, methodology): “Of the many techniques used for concentrating proteins, none are without problem”