Formulation and manufacturability of biologics.

By S. Shire. Current Opinion in Biotechnology, 2009

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The CamSol method of rational design of protein mutants with enhanced solubility. (2015, background): “Thus, protein aggregation represents also a major biotechnological issue, preventing many proteins to be produced at economically convenient yields [13,20,22].”
The immunogenicity of humanized and fully human antibodies (2010, background): “Extrinsic factors such as aggregates and adjuvant-like contaminants are well known to cause issues and have been largely resolved by improvements in manufacturing and formulating practices.(19,20) Extrinsic factors such as the co-medication of the patient, and the patient’s immunological status can ”
Utilizing graph machine learning within drug discovery and development (2021, background): “New biological entities (NBE) refer to biological products or biologics, that are produced in living systems [183].”