Research ArticlePharmaceutical BiotechnologyStrategies for Setting Patient-Centric Commercial Specifications for Biotherapeutic Products
Pharmaceutical Biotechnology
Under a Creative Commons license
open access
Keywords
Monoclonal antibody(s)
Antibody drug conjugate
Regulatory science
Biopharmaceutical characterization
Compendium
Physicochemical
Quality by design
Abbreviations
ADC
antibody drug conjugate
ADCC
antibody dependent cellular cytotoxicity
ADCP
antibody dependent cellular phagocytosis
CDC
complement dependent cytotoxicity
CE-SDS
capillary electrophoresis sodium dodecyl sulfate
CIEF
capillary isoelectric focusing
CQA
Critical Quality Attribute
CZE
capillary zone electrophoresis
DS
drug substance
DP
drug product
ELISA
enzyme-linked immunosorbent assay
EOSL
end of shelf life
FcRn
neonatal Fc receptor
HILIC
hydrophilic interaction chromatography
ICH
International Council for Harmonization
IEC
ion exchange chromatography
IgG
immunoglobulin G
mAb
monoclonal antibody
PQA
product quality attribute
SEC-HPLC
size exclusion chromatography high-performance liquid chromatography
PK
pharmacokinetics
PD
pharmacodymanics
QbD
Quality by Design
RTRT
Real time release testing
RP-HPLC
reversed phase high-performance liquid chromatography
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© 2020 The Authors. Published by Elsevier Inc. on behalf of the American Pharmacists Association®.