Appendix
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Table 1. Acronyms Acronym
Definition
Source
1D
one-dimensional
HOS, Preface
2D
two-dimensional
HOS, Preface, Summary
3D
three-dimensional
HOS
ACN
acetonitrile
Covalent HOS
ACS
American Chemical Society
Summary
ADC
antibody drug conjugate
IM, Preface, Summary
ADCC
antibody-dependent cellular cytotoxicity
Summary
ADH
alcohol dehydrogenase
IM
AFM
atomic force microscopy
Aggregation, Summary
API
atmospheric pressure ionization
IM
API
active pharmaceutical ingredient
none of the chapters
ATD
arrival time distribution
IM
AUC
analytical ultracentrifugation
Aggregation
BIRD
blackbody infrared radiative dissociation
Preface
BLA
Biologics License Application
Aggregation, Summary
BME
β-mercaptoethanol
Preface
BS3
bis(sulfosuccinimidyl)suberate
Aggregation
BSA
bovine serum albumin
IM
BSC
biosafety cabinet
Adventitious
CCD
charge-coupled device
Aggregation, Adventitious, SMSLS Continued on next page.
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Table 1. (Continued). Acronyms Acronym
Definition
Source
CD
circular dichroism
Covalent HOS, HOS, Preface
CDC
complement-dependent cytotoxicity
Summary
cDNA
complementary DNA
Adventitious
CDR
complementaritydetermining region
Aggregation, HOS
CE
capillary electrophoresis cation exchange high-performance liquid
Aggregation, Preface
CEX-HPLC
chromatography
Summary
CFU
colony-forming unit
Adventitious
CGS
centimeter, gram, second
SMSLS
CHO
Chinese hamster ovary
HOS, Adventitious
CID
collision-induced dissociation
Aggregation, Bioinformatics, HOS, Preface
cIEF
capillary isoelectric focusing
Summary
CIU
collision-induced unfolding
IM
CL
covalent labeling
Covalent HOS
Cp
crossing point
Adventitious
CPE
cytopathic effect
Adventitious
cryoprobe
cryogenically cooled probe
HOS
Ct
threshold cycle
Adventitious
CTD
charge transfer dissociation
Preface
dAb
domain antibody
Aggregation
DAR
drug-to-antibody ratio
Summary
DC
direct current
IM
DHSS
diffuse hard sphere scattering
IM
DLS
dynamic light scattering
SMSLS
dNTP
deoxynucleotide triphosphate
Adventitious
DR
dose response
Covalent HOS
DSC
differential scanning calorimetry
Aggregation, HOS, Preface, Summary
dSEC
denatured SEC
Summary Continued on next page.
434 Schiel et al.; State-of-the-Art and Emerging Technologies for Therapeutic Monoclonal Antibody Characterization Volume 3. ... ACS Symposium Series; American Chemical Society: Washington, DC, 2015.
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Table 1. (Continued). Acronyms Acronym
Definition
Source
DTT
dithiothreitol
Covalent HOS, Preface
E. coli
Escherichia coli
HOS
ECD
electron capture dissociation Easy Comparability of Higher Order Structure
Bioinformatics, HOS, Preface
ECHOS-NMR
by NMR 1-ethyl-3-(3dimethylaminopropyl)
HOS
EDC
carbodiimide
Covalent HOS
eFT
enhanced Fourier transformation
IM
EHSS
elastic/exact hard sphere scattering
IM
ELISA
enzyme-linked immunosorbent assay
Preface
EMR
extended mass range
IM
ER
endoplasmic recticulum
Aggregation
ESI
electrospray ionization
IM, Preface
ESI-MS
electrospray ionization mass spectrometry
Aggregation, Summary
ETD
electron transfer dissociation
Bioinformatics, HOS, Preface
ETS
Error Tolerance Search
Bioinformatics
Fab
antigen binding fragment
HOS, IM
Fc
crystallizable fragment
HOS, IM
FDA
Food and Drug Administration
Adventitious, Preface, Summary
FDR
false discovery rate fraction of the solvent-accessible side chain
Bioinformatics
fSASA
surface area
Covalent HOS
FT-ICR
Fourier transform ion cyclotron resonance
Bioinformatics, HOS, Preface
FTIR
Fourier transform infrared
Aggregation, HOS, Preface, Summary
Fv
variable fragment
HOS
FWHM
full width at half maximum
Preface Continued on next page.
435 Schiel et al.; State-of-the-Art and Emerging Technologies for Therapeutic Monoclonal Antibody Characterization Volume 3. ... ACS Symposium Series; American Chemical Society: Washington, DC, 2015.
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Table 1. (Continued). Acronyms Acronym
Definition
Source
GCSF
granulocyte colonystimulating factor
Covalent HOS
GDH
glutamate dehydrogenase
IM
GEE
glycine ethyl ester
Covalent HOS
GLP
good laboratory practice
Covalent HOS
H
heavy
Covalent HOS
HC
heavy chain
HOS
HCCF
harvested cell culture fluid
Adventitious
HCD
higher energy collision-induced dissociation
Preface
HCD
higher energy collisional dissociation
IM
HCID
higher-energy collision-induced dissociation
Bioinformatics
HCP
host cell protein
Bioinformatics, Preface, Summary
HDMS
high definition mass spectrometer
IM
HDX
hydrogen-deuterium exchange hydrogen-deuterium exchange mass
Covalent HOS, Preface
HDX-MS
spectrometry hydrophilic interaction liquid
HOS, Summary
HILIC
chromatography heteronuclear multiple quantum coherence
IM
HMQC
spectroscopy
HOS
HPLC
high-performance liquid chromatography
Aggregation
HPLC
high pressure liquid chromatography
Covalent HOS, Preface
HRF
hydroxyl radical-based footprinting
Covalent HOS Continued on next page.
436 Schiel et al.; State-of-the-Art and Emerging Technologies for Therapeutic Monoclonal Antibody Characterization Volume 3. ... ACS Symposium Series; American Chemical Society: Washington, DC, 2015.
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Table 1. (Continued). Acronyms Acronym
Definition
Source
HSQC
heteronuclear single quantum correlation heteronuclear single quantum coherence
Aggregation
HSQC
spectroscopy
HOS
IAA
iodoacetic acid International Conference on Harmonization of Technical Requirements for Registration of
Covalent HOS
ICH
Pharmaceuticals for Human Use
Adventitious, Summary
IFN
Interferon Alpha-2
HOS
Ig
immunoglobulin
HOS
IgG
immunoglobulin G
Summary
IM
ion mobility
IM
IMS
ion mobility system
IM
IRMPD
infrared multiphoton dissociation
Preface
ISD
in-source decay
Preface
L
light
Covalent HOS
LAL
Limulus amoebocyte lysate
Adventitious
LC
liquid chromatography
Bioinformatics, IM, Preface
LC
light chain
HOS
LC-MS
liquid chromatography-mass spectrometry
Aggregation, Covalent HOS, Preface, Summary
LC-UV
liquid chromatography-UV LRR and Ig domaincontaining, Nogo
Preface
LINGO
receptor-interacting protein time-dependent total intensity light
Aggregation
LS
scattering
SMSLS
LTQ
linear trap quadrupole
Bioinformatics
MAA
Marketing Authorization Application
Aggregation
mAb
monoclonal antibody
Aggregation, Bioinformatics, Covalent HOS, HOS, Continued on next page.
437 Schiel et al.; State-of-the-Art and Emerging Technologies for Therapeutic Monoclonal Antibody Characterization Volume 3. ... ACS Symposium Series; American Chemical Society: Washington, DC, 2015.
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Table 1. (Continued). Acronyms Acronym
Definition
Source
MALDI
matrix-assisted laser desorption/ionization
Bioinformatics, IM, Preface
MALDI-TOF-MS
matrix assisted laser desorption/ionization-time of flight-mass spectrometry
Aggregation
MALS
multi-angle light scattering
SMSLS
MCO
metal-catalyzed oxidation
Aggregation
MD
molecular dynamics
IM
MKSA
meter, kilogram, second, ampere
SMSLS
MMV
minute virus of mice
Adventitious
MOA
mechanism of action
Summary
MS
mass spectrometry
Bioinformatics, Covalent HOS, IM, Summary
MS/MS
tandem mass spectrometry
Bioinformatics, Covalent HOS, Summary
Mw
molecular weight
IM
MWCO
molecular-weight cutoff
Covalent HOS, IM
NAT
Nucleic Acid Amplification Techniques
Adventitious
NC
negative control
Adventitious
NDF
neutral density filter
SMSLS
near-UV CD
Near-UV circular dichroism
Summary
NEC
negative extraction control
Adventitious
nESI
nano-electrospray ionistion
IM
NET
Normalized Elution Time
Bioinformatics
NHS
N-hydroxysuccinimide National Institute of Standards and
Aggregation
NIST
Technology
HOS, Preface, Summary
NISTmAb RM
NISTmAb reference material
Summary
NMR
nuclear magnetic resonance Nuclear Overhauser Enhancement
Covalent HOS, HOS, IM, Preface, Summary Continued on next page.
438 Schiel et al.; State-of-the-Art and Emerging Technologies for Therapeutic Monoclonal Antibody Characterization Volume 3. ... ACS Symposium Series; American Chemical Society: Washington, DC, 2015.
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Table 1. (Continued). Acronyms Acronym
Definition
Source
NOESY
Spectroscopy non-reduced capillary sodium dodecyl sulfate
HOS
nrcSDS
electrophoresis
Summary
oaToF
orthogonal acceleration time-of-flight
IM
PA
projected area approximation
IM
PAGE
polyacrylamide gel electrophoresis
Adventitious
PC
positive control
Adventitious
PCR
polymerase chain reaction
Adventitious, Preface
PDB
protein data bank
Aggregation, Covalent HOS, HOS, IM
PF
protection factor
Covalent HOS
PFS
prefilled syringes
Aggregation
pI
isoelectric point
Aggregation
PK
pyruvate kinase
IM
PMF
peptide mass fingerprinting
Bioinformatics
PNGase F
Peptide-N-Glycosidase F
Covalent HOS
PQA
product quality attribute PROtein FIngerprint by Line shape
Bioinformatics
PROFILE
Enhancement
HOS
PSA
prostate-specific antigen
Bioinformatics
PTFE
polytetrafluoroethylene
SMSLS
PTM
post-translational modification
Bioinformatics, HOS, Preface, Summary
QbD
quality by design
Bioinformatics
q-PCR
quantitative PCR
Adventitious
QToF
quadrupole-time-of-flight
Bioinformatics, IM
R&D
research and development
Aggregation
RC
rate constant
Covalent HOS Continued on next page.
439 Schiel et al.; State-of-the-Art and Emerging Technologies for Therapeutic Monoclonal Antibody Characterization Volume 3. ... ACS Symposium Series; American Chemical Society: Washington, DC, 2015.
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Table 1. (Continued). Acronyms Acronym
Definition
Source
rCGE
reduced capillary gel electrophoresis reduced capillary sodium dodecyl sulfate
Aggregation
rcSDS
electrophoresis reduced, denatured size exclusion
Summary
rdSEC
chromatography
Summary
RF
radio frequency human granulocyte macrophage-colony
IM
rhGM-CSF
stimulating factor
HOS
RM
reference material
Adventitious
ROA
Raman optical activity
HOS
ROC
receiver operating characteristic
Bioinformatics
RP
reversed-phase reversed phase-highperformance liquid
Bioinformatics
RP-HPLC
chromatography
Aggregation
RPM
revolutions per minute
SMSLS
S/N
signal to noise ratio
Bioinformatics, HOS
SANS
small-angle neutron scattering
Aggregation
SAP
spatial aggregation propensity
Aggregation
SAP
serum amyloid protein
IM
SASA
solvent-accessible side chain surface area
Covalent HOS
SAXS
small-angle X-ray scattering
Aggregation
scFv
single chain variable fragment
Aggregation
SDS
sodium dodecyl sulfate sodium dodecyl sulfate-polyacrylamide gel
Preface
SDS-PAGE
electrophoresis
Aggregation Continued on next page.
440 Schiel et al.; State-of-the-Art and Emerging Technologies for Therapeutic Monoclonal Antibody Characterization Volume 3. ... ACS Symposium Series; American Chemical Society: Washington, DC, 2015.
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Table 1. (Continued). Acronyms Acronym
Definition
Source
SEC
size exclusion chromatography size exclusion chromatography-multiangle
Aggregation, Preface, Summary
SEC-MALLS
laser light scattering size exclusion chromatography with static
Aggregation
SEC-SLS
light scattering detection
Summary
SI
International System of Units
HOS, SMSLS, Summary
SIC
selected ion chromatogram
Covalent HOS
SID
surface-induced dissociation
Aggregation, Bioinformatics, Preface
SLS
static light scattering
SMSLS
SMSLS
simultaneous multiple sample light scattering
SMSLS
SNase
staphylococcal nuclease sedimentation velocity analytical
HOS
SV-AUC
ultracentrifugation
Summary
TCEP
tris(2-carboxyethyl)phosphine
Covalent HOS, Preface
TEM
transmission electron microscopy
Summary
TM
trajectory method
IM
TOF
time of flight
Bioinformatics, Preface
TOP
take-off point Transverse RelaxationOptimized
Adventitious
TROSY
Spectroscopy
HOS
TSE
transmissible spongiform encephalopathy
Adventitious
TWIM
travelling wave ion mobility
IM
UHV
ultra high vacuum
IM
UPLC
ultrahigh performance liquid chromatography
Bioinformatics, HOS, IM Continued on next page.
441 Schiel et al.; State-of-the-Art and Emerging Technologies for Therapeutic Monoclonal Antibody Characterization Volume 3. ... ACS Symposium Series; American Chemical Society: Washington, DC, 2015.
Table 1. (Continued). Acronyms Definition
Source
USP
U.S. Pharmacopeial Convention
Adventitious
VCD
vibrational circular dichroism
HOS
XIC
extracted ion chromatogram
Bioinformatics, Summary
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Acronym
442 Schiel et al.; State-of-the-Art and Emerging Technologies for Therapeutic Monoclonal Antibody Characterization Volume 3. ... ACS Symposium Series; American Chemical Society: Washington, DC, 2015.
