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Analytical and Bioanalytical Chemistry

, Volume 411, Issue 13, pp 2867–2883 | Cite as

Usability of NISTmAb reference material for biosimilar analytical development

  • Neh Nupur
  • Anurag S. RathoreEmail author
Research Paper

Abstract

With the number of approved biosimilars rapidly increasing in the various regulatory jurisdictions, public perception of safety and efficacy of these products have been gradually improving. Establishment of analytical similarity with the innovator product is a key aspect of biosimilar development. It serves as the basis for reduction in the size and/or scope of clinical trials. However, the clinical performance must be consistent with the innovator product. A considerable amount of effort precedes this exercise and requires a suitable reference material to support analytical method development. In view of the high cost as well as limited availability of innovator product in the market, there is a need for suitable reference material which could serve this purpose. The National Institute of Standards and Technology (NIST) have recently created NIST monoclonal antibody (NISTmAb) to support analytical method development and commercialization of monoclonal antibody-based biotherapeutics. In this paper, it is intended to evaluate lifecycle appropriate implementation of NISTmAb, a class-specific reference material in biosimilar analytical development. The results show that NISTmAb can be useful in developing initial platform analytical methods and as an external control for class-specific products. However, as expected, it cannot replace an innovator product or in-house product-specific reference material for analytical similarity assessment. As per regulatory guideline, a product-specific optimization will continue to be a prerequisite for specific analytical properties.

Keywords

Analytical similarity Biosimilars Class-specific Monoclonal antibody NISTmAb Reference material 

Abbreviations

ACN

Acetonitrile

ADCC

Antibody-dependent cell-mediated cytotoxicity

AF4

Asymmetric field-flow fractionation

AFM

Atomic force microscopy

ANS

1-Anilino-8-naphthalenesulfonate

APS

Ammonium persulfate

C

Cysteine

c

Concentration

CL,CH

Constant

CD

Circular dichroism

CDC

Complement-dependent cytotoxicity

CE

Capillary electrophoresis

CEX-HPLC

Cation exchange-high performance liquid chromatography

CHO

Chinese Hamster Ovary

cIEF

Capillary isoelectric focusing

CM

Carboxymethyl

cm

Centimeter

CpB

Carboxypeptidase B

CQAs

Critical quality attributes

CZE

Capillary zone electrophoresis

°C

Degree Celsius

D

Aspartate

d

Diffusion coefficient

Da

Dalton

DLS

Dynamic light scattering

DSC

Differential scanning calorimetry

DTT

Dithiothreitol

EDTA

Ethylenediaminetetraacetic acid

EMA

European Medicines Agency

ELISA

Enzyme-linked immunosorbent assay

ESI-TOF-MS

Electrospray ionization-time-of-flight-mass spectrometry

F

Phenylalanine

FA

Formic acid

FDA

Food and Drug Administration

FI

Flow imaging

FLD

Fluorescence detector

FTIR

Fourier transform infrared spectroscopy

GHz

Gigahertz

Gn-HCl

Guanidine hydrochloride

H

Heavy

HCD

Host cell DNA

HCP

Host cell protein

HDX

Hydrogen deuterium exchange

HILIC

Hydrophilic interaction chromatography

HMW

High molecular weight

HOS

Higher order structure

hrs

Hours

IAM

Iodoacetamide

ICH

International Conference on Harmonization

IgG

Immunoglobulin

IR

Infrared

kB

Boltzmann constant

KD

Equilibrium constant

L

Light

LO

Light obscuration

LC

Liquid chromatography

LMW

Low molecular weight

K

Lysine

l

Path length

M

Methionine

Mo

Mean residue weight

MAb

Monoclonal antibody

MALS

Multi-angle light scattering

mdeg

Millidegree

MFE

Molecular feature extraction

mg

Milligram

min

Minute

mM

Millimolar

mPa

MilliPascal

MRE

Mean residue ellipticity

MS

Mass spectrometry

mU

Milliunits

m/z

Mass/charge

N

Asparagine

Na3PO4

Sodium phosphate

NaCl

Sodium chloride

NaN3

Sodium azide

NIST

National Institute of Standards and Technology

nm

Nanometer

NMR

Nuclear magnetic resonance

NTA

Nanoparticle tracking analysis

OD

Optical density

PAGE

Polyacrylamide gel electrophoresis

Ph. Eur.

European Pharmacopeia

pI

Isoelectric point

PTMs

Post-translational modifications

pyroQ

Pyroglutamate

Q

Glutamate

qPCR

Quantitative polymerase chain reaction

QTOF-MS

Quadrupole-time-of-flight-mass spectrometry

RH

Hydrodynamic size

RP-HPLC

Reversed phase-high performance liquid chromatography

RT

Retention time

s

Second

SD

Standard deviation

SDS

Sodium dodecyl sulfate

SE-HPLC

Size exclusion-high performance liquid chromatography

SMSLS

Simultaneous multiple sample light scattering

SPR

Surface plasmon resonance

SV-AUC

Sedimentation velocity-analytical ultracentrifugation

S-S

Disulfide bridges

T

Absolute temperature

TEM

Transmission electron microscopy

TEMED

Tetramethylethylenediamine

TIC

Total ion chromatogram

Tris-HCl

Tris hydrochloride

USP

United States Pharmacopeia

UV

Ultraviolet

V

Volt

Vcap

Capillary voltage

Vfrag

Fragmentor voltage

VL,VH

Variable

VIS

Visible

W

Tryptophan

WHO

World Health Organization

Y

Tyrosine

2AB

2-Aminobenzamide

ηs

Solvent viscosity

θ

Observed ellipticity

λmax

Maximum wavelength

μL

Microliter

Notes

Acknowledgments

The authors would like to acknowledge John E. Schiel, John P. Marino, and Michael J. Tarlov from the National Institute of Standards and Technology for providing the reference material, NISTmAb RM 8671, and Agilent Technologies India Pvt. Ltd. for providing technical support. The authors would also like to thank Dr. Rozaleen Dash, Post Doctorate student, IIT Delhi, India, for the SPR analysis.

Funding

This work was funded by the Center of Excellence for Biopharmaceutical Technology grant under the Department of Biotechnology, Government of India (BT/COE/34/SP15097/2015).

Compliance with ethical standards

Conflict of interest

The authors declare that they have no conflict of interest.

Research involving human participants and/or animals

No human or animal subjects were used in the study.

Informed consent

No informed consent was required in the study.

Supplementary material

216_2019_1735_MOESM1_ESM.pdf (402 kb)
ESM 1 (PDF 401 kb)

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Copyright information

© Springer-Verlag GmbH Germany, part of Springer Nature 2019

Authors and Affiliations

  1. 1.Department of Chemical EngineeringIIT DelhiNew DelhiIndia

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