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2 protocols using poloxamer 188 10 solution

1

Quantitative Mass Spectrometry of Monoclonal Antibodies

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Phosphoric acid 85% solution, tris(hydroxymethyl) aminomethane (Tris), T‐EthA, TEA, poloxamer 188 10% solution, PB, DXS, dimethylsulfoxide (DMSO) and Protein A agarose were obtained from Merck/Sigma‐Aldrich (Darmstadt, Germany). HyClone ActiPro medium was purchased from Cytiva (Marlborough, USA). Three commercially available mAbs were purchased, NIST mAb reference material (NIST) (10 mg/ml in 12.5 mM l‐histidine, 12 mM l‐histidine HCl) and SILuLite SigmaMAb Rituximab mAb were from Sigma‐Aldrich (Darmstadt, Germany), and Intact mAb Mass Check Standard was from Waters (Milford, USA), hereafter referred to as NIST mAb, Rituximab and Waters mAb. For method validation, adalimumab (10 mg/ml in 12.5 mM histidine buffer) was purchased from Merck/Sigma‐Aldrich (Darmstadt, Germany). Spent cell‐culture medium samples of process A after 6, 10 or 14 days of cultivation and purified drug substance (DS) samples were provided by Byondis BV, Nijmegen, the Netherlands. Spent cell‐culture medium samples of process B after 0, 5 or 8 days of cultivation and process C after 0 or 7 days of cultivation were provided by the Department of Industrial Biotechnology, KTH Royal Institute of Technology, Stockholm, Sweden. All chemicals were of analytical grade, water was of Milli‐Q grade (18.2 MΩ cm).
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2

Glyceryl Palmitostearate Formulation for Therapeutic Delivery

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Precirol ATO5 (glyceryl palmitostearate) was obtained from Gattefosse (Saint-Priest, France) and Miglyol 812 was received from Sasol (Hamburg, Germany). Carbopol 940 was purchased from Acros (Morris County, NJ, USA). Triethanolamine (TEA) was purchased from Merck (Darmstadt, Germany). RhTM protein and anti-rhTM antibody were provided by Blue Blood Biotech Corporation (Taipei, Taiwan). H&E stain, Poloxamer 188 (10% solution), bovine serum albumin (BSA) and phosphate buffered saline (PBS) were purchased from Sigma-Aldrich (St. Louis, MO, USA). Streptozotocin (STZ) was obtained from Cayman Chemical (Ann Arbor, MI, USA). DMEM and fetal bovine serum (FBS) were purchased from GE Healthcare (Pittsburgh, PA, USA). Formaldehyde solution was from Avantor (Center Valley, PA, USA), and penicillin-streptomycin was from Gibco (Waltham, MA, USA).
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