Stability of buffer-free freeze-dried formulations: A feasibility study of a monoclonal antibody at high protein concentrations

European Journal of Pharmaceutics and Biopharmaceutics

Volumn 97, Issue , 2015, Pages 125-139

  Garidel, Patrick ^a   Pevestorf, Benjamin ^a   Bahrenburg, Sven ^a  

^a BOEHRINGER INGELHEIM PHARMA GMBH AND CO KG   (Germany)

Author keywords

Abbreviation mAb monoclonal antibody

Indexed keywords

BUFFER; DISACCHARIDE; EXCIPIENT; MONOCLONAL ANTIBODY; MONOMER; PROTEIN;

ANIMAL CELL; ARTICLE; CHO CELL LINE; CONTROLLED STUDY; DRUG FORMULATION; DRUG STABILITY; FEASIBILITY STUDY; FEMALE; FREEZE DRIED FORMULATION; FREEZE DRYING; HUMIDITY; HYDROPHOBIC INTERACTION CHROMATOGRAPHY; IN VITRO STUDY; LIQUID; NONHUMAN; OSMOLALITY; PARTICLE SIZE; PH; PROTEIN AGGREGATION; PROTEIN ANALYSIS; PROTEIN STABILITY; CHEMICAL PHENOMENA; CHEMISTRY; DRUG STORAGE; MEDICINAL CHEMISTRY; PROCEDURES; TIME FACTOR;

ANTIBODIES, MONOCLONAL; BUFFERS; CHEMISTRY, PHARMACEUTICAL; DRUG COMPOUNDING; DRUG STORAGE; EXCIPIENTS; FEASIBILITY STUDIES; FREEZE DRYING; HYDROGEN-ION CONCENTRATION; HYDROPHOBIC AND HYDROPHILIC INTERACTIONS; PROTEIN STABILITY; TIME FACTORS;

EID: 84946219957     PISSN: 09396411     EISSN: 18733441     Source Type: Journal    
DOI: 10.1016/j.ejpb.2015.09.017     Document Type: Article

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