Developability studies before initiation of process development: Improving manufacturability of monoclonal antibodies

mAbs

Volumn 5, Issue 5, 2013, Pages 787-794

  Yang, Xiaoyu ^a   Xu, Wei ^a   Dukleska, Svetlana ^a   Benchaar, Sabrina ^a   Mengisen, Selina ^a   Antochshuk, Valentyn ^a   Cheung, Jason ^a   Mann, Leslie ^a   Babadjanova, Zulfia ^a   Rowand, Jason ^a   Gunawan, Rico ^a   McCampbell, Alexander ^a   Beaumont, Maribel ^a   Meininger, David ^a   Richardson, Daisy ^a   Ambrogelly, Alexandre ^a  

^a MERCK RESEARCH LABORATORIES   (United States)

Author keywords

Analytics; CQA; Developability; Development; Discovery; Forced degradation; Process control; QbD; Stability

Indexed keywords

METHIONINE; MONOCLONAL ANTIBODY;

ARTICLE; DRUG MANUFACTURE; DRUG STABILITY; DRUG STORAGE; FREEZE THAWING; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; STRESS;

ANALYTICS; CQA; DEVELOPABILITY; DEVELOPMENT; DISCOVERY; FORCED DEGRADATION; PROCESS CONTROL; QBD; STABILITY;

ANTIBODIES, MONOCLONAL; CHEMISTRY, PHARMACEUTICAL; CHROMATOGRAPHY, HIGH PRESSURE LIQUID; DRUG APPROVAL; DRUG DISCOVERY; DRUG STABILITY; HUMANS; MASS SPECTROMETRY; SOLUBILITY; TECHNOLOGY, PHARMACEUTICAL; TEMPERATURE; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION; VISCOSITY;

EID: 84883856643     PISSN: 19420862     EISSN: 19420870     Source Type: Journal    
DOI: 10.4161/mabs.25269     Document Type: Article

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