Appendix - American Chemical Society

Aggregation, Bioinformatics,. HOS, Preface. cIEF capillary isoelectric focusing Summary. CIU collision-induced unfolding. IM. CL covalent labeling. Co...
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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.

© 2015 American Chemical Society 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

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.