High-Throughput, Fluorescence-Based Esterase Activity Assay for Assessing Polysorbate Degradation Risk during Biopharmaceutical Development

[1] Kerwin BA(2008)Polysorbates 20 and 80 used in the formulation of protein biotherapeutics: structure and degradation pathways J Pharm Sci 97 2924-2935

[2] Khan TA(2015)Key interactions of surfactants in therapeutic protein formulations: a review Eur J Pharm Biopharm 97 60-67

[3] Mahler HC(2011)The degradation of polysorbates 20 and 80 and its potential impact on the stability of biotherapeutics Pharm Res 28 1194-1210

[4] Kishore RS(2011)Degradation of polysorbates 20 and 80: studies on thermal autoxidation and hydrolysis J Pharm Sci 100 721-731

[5] Kishore RS(2015)Understanding particle formation: solubility of free fatty acids as polysorbate 20 degradation byproducts in therapeutic monoclonal antibody formulations Mol Pharm 12 3792-3804

[6] Kiese S(2008)Quantitation of polysorbate 20 in protein solutions using mixed-mode chromatography and evaporative light scattering detection J Chromatogr A 1215 156-160

[7] Fischer S(2011)Mixed-mode and reversed-phase liquid chromatography-tandem mass spectrometry methodologies to study composition and base hydrolysis of polysorbate 20 and 80 J Chromatogr A 1218 2138-2145

[8] Pappenberger A(2015)Polysorbate 20 degradation in biopharmaceutical formulations: quantification of free fatty acids, characterization of particulates, and insights into the degradation mechanism Mol Pharm 12 3805-3815

[9] Grauschopf U(2016)Polysorbates 20 and 80 degradation by group XV lysosomal phospholipase A2 isomer X1 in monoclonal antibody formulations J Pharm Sci 105 1633-1642

[10] Mahler HC(2019)A rapid high-sensitivity reversed-phase ultra high performance liquid chromatography mass spectrometry method for assessing polysorbate 20 degradation in protein therapeutics J Pharm Sci 108 2880-2886

[1] Kerwin BA(2008)Polysorbates 20 and 80 used in the formulation of protein biotherapeutics: structure and degradation pathways J Pharm Sci 97 2924-2935

[2] Khan TA(2015)Key interactions of surfactants in therapeutic protein formulations: a review Eur J Pharm Biopharm 97 60-67

[3] Mahler HC(2011)The degradation of polysorbates 20 and 80 and its potential impact on the stability of biotherapeutics Pharm Res 28 1194-1210

[4] Kishore RS(2011)Degradation of polysorbates 20 and 80: studies on thermal autoxidation and hydrolysis J Pharm Sci 100 721-731

[5] Kishore RS(2015)Understanding particle formation: solubility of free fatty acids as polysorbate 20 degradation byproducts in therapeutic monoclonal antibody formulations Mol Pharm 12 3792-3804

[6] Kiese S(2008)Quantitation of polysorbate 20 in protein solutions using mixed-mode chromatography and evaporative light scattering detection J Chromatogr A 1215 156-160

[7] Fischer S(2011)Mixed-mode and reversed-phase liquid chromatography-tandem mass spectrometry methodologies to study composition and base hydrolysis of polysorbate 20 and 80 J Chromatogr A 1218 2138-2145

[8] Pappenberger A(2015)Polysorbate 20 degradation in biopharmaceutical formulations: quantification of free fatty acids, characterization of particulates, and insights into the degradation mechanism Mol Pharm 12 3805-3815

[9] Grauschopf U(2016)Polysorbates 20 and 80 degradation by group XV lysosomal phospholipase A2 isomer X1 in monoclonal antibody formulations J Pharm Sci 105 1633-1642

[10] Mahler HC(2019)A rapid high-sensitivity reversed-phase ultra high performance liquid chromatography mass spectrometry method for assessing polysorbate 20 degradation in protein therapeutics J Pharm Sci 108 2880-2886