volume 109, issue 12, P3579-3589 2020
DOI: 10.1016/j.xphs.2020.09.014
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Abstract: Monoclonal antibodies requiring higher doses for exerting therapeutic effect but having lower stability, are administered as dilute infusions, or as two (low concentration) injections both resulting in reduced patient compliance. Present research summarizes impact of manufacturing conditions on ultra-high concentration (≥150mg/mL) IgG1 formulation, which can be administered as one subcutaneous injection. IgG1 was concentrated to ∼200mg/mL using tangential flow filtration (TFF). Alternatively, spray dried (SPD)…

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