Appendix Table 1. Acronyms Acronym
Definition
2-AA
anthranilic acid
2-AB
2-aminobenzamide
AARS
aminoacyl-tRNA synthetases
ADC
antibody drug conjugate
ADCC
antibody-dependent cellular cytotoxicity
AEX
anion exchange chromatography
AF4
asymmetric flow field-flow fractionation
AFM
atomic force microscopy
AGE
advanced glycation end product
APC
antigen-presenting cell
API
active pharmaceutical ingredient
ASGPR
asialoglycoprotein receptor
Asn
asparagine
Asp
aspartic acid
AUC
analytical ultracentrifugation
AuC
area under the curve
CAGR
compound annual growth rate
CD
circular dichroism
CDC
complement-dependent cytotoxicity
cDNA
complementary DNA
CDR
complementarity-determining region
CE
capillary electrophoresis
CEX
cation exchange chromatography
CFR
Code of Federal Regulations
cGMP
current good manufacturing practice Continued on next page.
© 2014 American Chemical Society
Table 1. (Continued). Acronyms Acronym
Definition
CH1, CH2, CH3
constant domains 1, 2 and 3 of antibody heavy chain
CHO
Chinese hamster ovary
cIEF
capillary isoelectric focusing
CL
constant domain of antibody light chain
CMC
chemistry, manufacturing, and controls
CMP
cytidine monophosphate
CQA
critical quality attribute
CRM
certified reference material
cSDS
capillary sodium dodecylsulfate electrophoresis
CTD
Common Technical Document
Cys
cysteine
CZE
capillary zone electrophoresis
d
denatured
DHFR
dihydrofolate reductase
DLS
dynamic light scattering
DMA
differential mobility analyzer
DMB
1,2-diamino-4,5-methylenoxybenzene
DoE
design of experiments
DP
drug product
DS
drug substance
DSC
differential scanning calorimetry
DSMC
differential scanning micro-calorimetry
E. coli
Escherichia coli
EMA
European Medicines Authority
EndoH
endoglycosidase H
EndoS
endoglycosidase S
EPO
erythropoietin
ESI
electrospray ionization
Fab
antigen-binding fragment
Fabs
antigen-binding fragments
FDA
U.S. Food and Drug Administration
FFF
field flow fractionation Continued on next page.
152
Table 1. (Continued). Acronyms Acronym
Definition
FMEA
failure modes and effects
FTIR
Fourier transform infrared spectroscopy
Fv
fragment variable
GCSF
granulocyte colony stimulating factor
Gln
glutamine
GLP
good laboratory practice
GLP-Tox
Good Laboratory Practice-Toxicology
Gly
glycine
GMP
good manufacturing practice
GMP
good manufacturing practice
GPI
glycosylphosphatidylinositol
GS
glutamine synthetase
GS
glutathione synthase
H
heavy chain
H/D
hydrogen/deuterium
HCP
host cell protein
HDX
hydrogen-deuterium exchange
HIC
hydrophobic interaction chromatography
HILIC
hydrophilic interaction liquid chromatography
HMG
high-mannose glycan
HMW
high molecular weight
HPLC
high-performance liquid chromatography
ICH
International Conference on Harmonisation
icIEF
imaged capillary isoelectric focusing
IEF
isoelectric focusing
IEX
ion exchange chromatography
Ig
immunoglobulin
IM
ion mobility
INN
International Nonpropriertary Names
IPC
in-process control
ISO
International Organization for Standardization
ITAM
immunoreceptor tyrosine-based activation motif Continued on next page.
153
Table 1. (Continued). Acronyms Acronym
Definition
ITIM
immunoreceptor tyrosine-based inhibition motif
IV
intravenous
L
light chain
LALS
low-angle light scattering
LC-MS
liquid chromatography-mass spectrometry
LMW
low molecular weight
Lys
lysine
mAb
monoclonal antibody
mAbs
monoclonal antibodies
MALDI
matrix-assisted laser desorption/ionization
MALS
multi-angle light scattering
Man5
high-mannose glycan structure 5
Man9
high-mannose glycan structure 9
Met
methionine
MHC
major histocompatibility complex
MIRR
multi-chain immune recognition receptor
MoA
mechanism of action
mRNA
messenger RNA
MS
mass spectrometry
MSX
methionine sulfoximine
MTX
methotraxate
MW
molecular weight
NANA
N-acetylneuraminic acid
NANA
N-acetylneuraminic acid
Neu5Ac
N-acetylneuraminic acid
NGNA
N-glycolylneuraminic acid
NK
natural killer
NMR
nuclear magnetic resonance
nr
non-reduced
OPD
o-phenylenediamine
PAGE
polyacrylamide gel electrophoresis
PAT
process analytical technology Continued on next page.
154
Table 1. (Continued). Acronyms Acronym
Definition
PBMC
peripheral blood mononuclear cells
PCR
polymerase chain reaction
PD
pharmacodynamic
pI
isoelectric point
PK
pharmacokinetic
PNGase F
Peptide N-Glycosidase F
PPI
protein-protein interaction
PPQ
process performance qualification
PQA
product quality attribute
PQRA
Product Quality Risk Assessment
Pro
proline
PTM
post-translational modification
Q
quadrupole
QbD
quality by design
QC
quality control
r
reduced
R&D
research and development
RALS
right-angle light scattering
RF
rheumatoid factor
RM
NIST reference material
RP
reversed phase
SANS
small-angle neutron scattering
SAXS
small-angle X-ray scattering
scFv
single-chain fragment variable
SDS
sodium dodecylsulfate
SDS-PAGE
sodium dodecylsulfate-polyacrylamide gel electrophoresis
SEC
size exclusion chromatography
Ser
serine
SLS
static light scattering
SNP
single-nucleotide polymorphism
SpA
Staphylococcal protein A
SpG
Streptococcal protein G Continued on next page.
155
Table 1. (Continued). Acronyms Acronym
Definition
SRM
NIST standard reference material
SV
sedimentation velocity
SVA
sequence variant analysis
TEM
transmission electron microscopy
Thr
threonine
TNF
tumor necrosis factor
TOF
time-of-flight
tRNA
transfer RNA
Trp
tryptophan
TW
travelling wave
UHPLC
ultra-high pressure liquid chromatography
UPLC
ultra-high pressure liquid chromatography
USP
U.S. Pharmacopoeial Convention
VH
variable domain of antibody heavy chain
VL
variable domain of antibody light chain
WHO
World Health Organization
Table 2. Notes Incorrect
Term
Correct
CE
cation exchange chromatography
CEX
CE-IEF
capillary isoelectric focusing
cIEF
CE-SDS
capillary sodium dodecylsulfate electrophoresis
cSDS
HX
hydrogen-deuterium exchange
HDX
SE-HPLC
size exclusion chromatography
SEC
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