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Table 1. Acronyms 1-D
1-dimensional
2-AA
2-aminobenzoic acid
2-AB
2-aminobenzamide
2-D
2-dimensional
3-OH-Kyn
3-hydroxykynurenine
5-OH-Trp
5-hydroxyl-tryptophan
AAA
amino acid analysis
AAPH
2,2′-azobis(2-amidinopropane) dihydrochloride
AARS
aminoacyl-tRNA synthetases
ABS
Athrobacter ureafaciens sialidase
ABTS
2,2′-azinobis[3-ethylbenzothiazoline-6-sulfonic acid]-diammonium salt
ADA
anti-drug antibodies
ADC
antibody–drug conjugate
ADCC
antibody-dependent cellular cytotoxicity
ADCC
antibody-dependent, cell-mediated cytotoxicity
AFFFF
asymmetric flow field-flow fractionation
APTS
9-aminopyrene-1,4,6-trisulfonic acid
Asu
succinimide
ATR
attenuated total reflection
ATR-FTIR
attenuated total reflection-Fourier transform infrared
AUC
area under the curve
AUC
analytical ultracentrifugation
BCA
bicinchoninic acid assay
BKF
bovine kidney fucosidase
BLA
Biologics License Application
bp
base pairs Continued on next page.
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Technologies for Therapeutic Monoclonal Antibody Characterization Volume 2. Biopharmaceutical Characterization: The NISTmAb C ACS Symposium Series; American Chemical Society: Washington, DC, 2015.
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Table 1. (Continued). Acronyms BSA
bovine serum albumin
BTG
bovine testes β-galactosidase
C of A
Certificate of Analysis
CaCl2
calcium chloride
CBG
green coffee bean α-galactosidase
CCD
charge-coupled device
CD
circular dichroism
CDC
complement-dependent cytotoxicity
cDNA
complementary DNA
CDR
complementarity-determining regions
CE
capillary electrophoresis
CEX
cation exchange
CEX
cation exchange chromatography
CFG
Consortium for Functional Glycomics
CG-MALS
composition gradient-multi-angle light scattering
CH1
first constant domain of the heavy chain
CH2
second constant domains of the heavy chain
CH3
third constant domains of the heavy chain
CHO
Chinese hamster ovary
CIC
cross-interaction chromatography
CID
collision-induced dissociation
cIEF
capillary isoelectric focusing
CpB
carboxypeptidase B
CpG
cytosine-guanosine dinucleotide
CQA
critical quality attribute
cSDS
capillary sodium dodecylsulfate electrophoresis
cyno
cynomolgus
CZE
capillary zone electrophoresis
DAD
diode array detector
DDA
data-dependent acquisition
DHFR
dihydrofolate reductase
DIA
Data Independent Analysis
DIGE
difference gel electrophoresis Continued on next page.
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Table 1. (Continued). Acronyms diH2O
deionized water
DiOia
dioxindolylalanine diastereomers
DLS
dynamic light scattering
DMSO
dimethylsulfoxide
DOE
design of experiment
DPBS
14190-DPBS obtained from Life Technologies
DPBS
Dulbecco’s phosphate-buffered saline
DSC
differential scanning calorimetry
DSF
differential scanning fluorimetry
DTT
dithiothreitol
E. coli
Escherichia coli
EDTA
ethylenediaminetetraacetic acid
EI
electron impact
EIC
extracted ion chromatograms
EI-GC-MS
electron impact-gas chromatography-mass spectrometry
ELISA
enzyme-linked immunosorbent assay
ELSD
evaporating light scattering detector
EMEA
European Medicines Agency
ESI
electrospray ionization
ESZ
electrical sensing zone
ETD
electron transfer dissociation
ETS
error tolerant search
FA
formic acid
FAB
fast atom bombardment
FcRn
neonatal Fc receptor
FDA
Food and Drug Administration
FDA
U.S. Food and Drug Administration
FFF
field-flow fractionation
FI
flow imaging
FLD
fluorescence detection
FP
fusion protein
FQ
3-(2-furoyl)quinoline-2-carboxaldehyde
FR
fraction rate Continued on next page.
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Table 1. (Continued). Acronyms FRET
fluorescence resonance energy transfer
FTICR
Fourier transform ion cyclotron resonance
FTIR
Fourier-transform infrared spectroscopy
FTIR
Fourier transform infrared
FTN
flow through needle
GlcNAc
N-acetyl-glucosamine
GMP
good manufacturing practice
GS
glutamine synthetase
GU
glucose unit
GUH
Streptococcus pneumoniae hexosaminidase
H
heavy
H
heavy chain
HC
heavy chain
HCD
higher energy collision dissociation
HCD
higher energy collisional dissociation
HCID
higher energy collision-induced dissociation
HCl
hydrochloric acid
HCP
host cell protein
HDX
hydrogen-deuterium exchange
HESI
heated electrospray ionization source
hG-CSF
human granulocyte colony stimulating factor
HIC
hydrophobic interaction chromatography
HILIC
hydrophilic interaction liquid chromatography
HMWS
higher molecular weight species
HOS
higher order structure
HPLC
high-performance liquid chromatography
HPLC
high-pressure liquid chromatography
HRP
horseradish peroxidase
HRP II
histidine-rich protein II
HsTIM
homodimeric triosephosphate isomerase
HTP
High Throughput
IAA
iodoacetic acid
IAM
iodoacetamide Continued on next page.
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Table 1. (Continued). Acronyms ICH
International Conference on Harmonisation
ICIEF
imaged capillary isoelectric focusing
ICP-MS
inductively coupled plasma-mass spectrometry
ID
interior diameter
IEC
ion exchange chromatography
IEF
isoelectric focusing
IEX
ion exchange chromatography
IM-MS
ion mobility mass spectrometry
IRMPD
infrared multiphoton dissociation
iso-Asp
iso-aspartic acid
IUPAC
International Union of Pure and Applied Chemistry
KCN
potassium cyanide
Kyn
kynurenine
L
light
L
light chain
LC
liquid chromatography
LC
light chain
LC-MS
liquid chromatography-mass spectrometry
LC-MS/MS
liquid chromatography-tandem mass spectrometry
LC-UV-MS
liquid chromatography-UV-mass spectrometry
LED
light-emitting diode
LIF
laser-induced fluorescence
LLOQ
lower limit of quantitation
LO
light obscuration
LS
light scattering
LTQ
linear trap quadrupole
Lys-C
lysyl endopeptidase
mAb
monoclonal antibody
MALDI
matrix-assisted laser desorption ionization
MALDI-TOF
matrix assisted laser desorption/ionization-time of flight
MALS
multi-angle light scattering
MC
methylcellulose
MCAE
membrane-confined analytical electrophoresis Continued on next page.
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Table 1. (Continued). Acronyms MCE
microchip electrophoresis
MCE
membrane-confined electrophoresis
MCE-SSE
membrane-confined electrophoresis-steady-state electrophoresis
MCT
mercury cadmium telluride
MPA
mobile phase A
MPB
mobile phase B
MRE
mean residue ellipticity
MRM
multiple reaction monitoring
MS
mass spectrometry
MS/MS
tandem mass spectrometry
MS2
tandem mass spectrometry
MSn
sequential mass spectrometry
MSX
methionine sulfoximine
MTX
methotraxate
MW
molecular weight
MWCO
molecular weight cutoff
MWD
multiple wavelength detector
NA
not available
NaCNBH3
sodium cyanoborohydride
NaOH
sodium hydroxide
NCE
normalized collision energy
ND
not detected
NEM
N-ethylmaleimide
Neu5GC
N-glycolylneuraminic acid
NFK
N-formylkynurenine
NGH
non-glycosylated heavy chain
NGS
next-generation sequencing
NIBRT
National Institute for Bioprocessing Research and Training
NIST
National Institute of Standards and Technology
Nle
norleucine
NMR
nuclear magnetic resonance spectroscopy
NR
nonreducing
NS0
Murine Myeloma Continued on next page.
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Table 1. (Continued). Acronyms NSI-MS
MS nano-infusion mode
NTA
nanoparticle tracking analysis
Nva
norvaline
Oia
oxindolylalanine diastereomomers
OP
operational parameter
p/v
peak-to-valley
PAGE
polyacrylamide gel electrophoresis
PBS
phosphate-buffered saline
PCQA
potential critical quality attribute
PCR
polymerase chain reaction
PCS
photon correlation spectroscopy
Pd
polydispersity
PDA
photodiode array
PENNYK peptide
GFYPSDIAVEWESNGQPENNYK
pI
isoelectric point
PIMT
protein L-isoaspartyl methyltransferace
PNGase F
peptide N-glycosidase F
poly IgG
polyclonal IgG
PPG 2700
poly(propylene glycol) 2700
pQ
pyroglutamic acid
pre-mRNA
primary transcript messenger RNA
PRI
process-related impurity
PSL
polystyrene latex
PTM
post-translational modification
pyro-Glu
N-terminal pyroglutamate
QbD
quality by design
QC
quality control
QELS
quasi-elastic light scattering
qPCR
quantitative polymerase chain reaction
QTOF
quadrupole time-of-flight
qTOF
quantitative time-of-flight
R
correlation coefficient Continued on next page.
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Table 1. (Continued). Acronyms R
reducing
RA
relative abundance
RM
reference material
RMM
resonance mass measurement
RMSD
root-mean-square deviation
RP
reversed phase
RP-HPLC
reversed-phase-high-performance liquid chromatography
RPM
revolutions per minute
RSD
relative standard deviation
S/N
signal to noise
scFc
single chain Fc
SD
standard deviation
SDS
Sequence Detection System
SDS
sodium dodecyl sulfate
SDS-PAGE
sodium dodecyl sulfate-polyacrylamide gel electrophoresis
SE-AUC
sedimentation equilibrium-analytical ultracentrifugation
SEC
size exclusion chromatography
SEC-MALS
size exclusion chromatography-multi-angle light scattering
SIC
self-interaction chromatography
SINE
short interspersed repetitive elements
SLS
static light scattering
SNP
single-nucleotide polymorphism
SOP
standard operating procedure
SRDP
size-related degradation product
Sv
svedberg unit
SV
sequence variant
SVA
sequence variant analysis
SV-AUC
sedimentation velocity-analytical ultracentrifugation
TAMRA.SE
5-carboxytetra-methylrhodamine succinimidyl ester
t-BHP
tert-butyl hydroperoxide
TCEP
tris(2-carboxyethyl)phosphine
TETA
triethylenetetramine
TFA
trifluoroacetic acid Continued on next page.
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Table 1. (Continued). Acronyms TMB
3,3′,5,5′-tetramethylbenzidine
TOF
time-of-flight
TPP
target product profile
TRamp
temperature ramp
Tris
tris(hydroxymethyl)aminomethane
Tris
tris(hydroxymethyl)aminomethane/tris(hydroxymethyl)aminomethane HCl
tRNA
transfer RNA
TUV
tunable ultraviolet
UHPLC
ultrahigh-pressure liquid chromatography
UHPLC
ultra-high-performance liquid chromatography
UHR-ESIQTOF MS
ultrahigh-resolution-electrospray ionization-quadrupole time-of-flight mass spectrometry
UPLC
ultra performance liquid chromatography
USP
United States Pharmacopeia
VH
variable heavy
VWD
variable wavelength detector
WAX
weak anion exchange
WHO
World Health Organization
XIC
extracted ion chromatogram
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