title: Bulky Polar Additives That Greatly Reduce the Viscosity of Concentrated Solutions of Therapeutic Monoclonal Antibodies.
abstract: The viscosity of concentrated aqueous solutions of 3 clinical monoclonal antibodies (mAbs), Erbitux®, Herceptin®, and Rituxan®, has been reduced up to over 10-fold by adding certain bulky polar additives instead of saline at isotonic levels. Because these additives are also found not to compromise mAbs' stability against aggregation induced by stresses, a drug-delivery modality switch from intravenous infusions to more convenient and inexpensive parenteral options like subcutaneous injections may become possible.
authors.affiliation: Arsia Therapeutics, Cambridge, Massachusetts 02139. Electronic address: alarson@eagleus.com.
authors.forename: Alyssa M
authors.initials: AM
authors.lastname: Larson
authors.affiliation: Arsia Therapeutics, Cambridge, Massachusetts 02139.
authors.forename: Alisha K
authors.initials: AK
authors.lastname: Weight
authors.affiliation: Arsia Therapeutics, Cambridge, Massachusetts 02139.
authors.forename: Kevin
authors.initials: K
authors.lastname: Love
authors.affiliation: Arsia Therapeutics, Cambridge, Massachusetts 02139.
authors.forename: Amanda
authors.initials: A
authors.lastname: Bonificio
authors.affiliation: Arsia Therapeutics, Cambridge, Massachusetts 02139.
authors.forename: Charles R
authors.initials: CR
authors.lastname: Wescott
authors.affiliation: Arsia Therapeutics, Cambridge, Massachusetts 02139; Department of Chemistry, Massachusetts Institute of Technology, Cambridge, Massachusetts 02139; Department of Biological Engineering, Massachusetts Institute of Technology, Cambridge, Massachusetts 02139.
authors.forename: Alexander M
authors.initials: AM
authors.lastname: Klibanov
mesh_terms: D000911:Antibodies, Monoclonal / Q000737:chemistry* / Q000378:metabolism; D000068818:Cetuximab / Q000737:chemistry* / Q000378:metabolism; D002626:Chemistry, Pharmaceutical / Q000379:methods*; D002850:Chromatography, Gel / Q000379:methods; D019999:Pharmaceutical Solutions / Q000737:chemistry / Q000378:metabolism; D000068878:Trastuzumab / Q000737:chemistry* / Q000378:metabolism; D014783:Viscosity
chemical_list: D000911:Antibodies, Monoclonal; D019999:Pharmaceutical Solutions; D000068878:Trastuzumab; D000068818:Cetuximab
keywords: excipients; pharmaceutical formulation; proteins; stability; viscosity