Appendix - American Chemical Society

CH1, CH2, CH3 constant domains 1, 2 and 3 of antibody heavy chain. CHO. Chinese hamster ovary. cIEF capillary isoelectric focusing. CL constant domain...
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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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