PMID- 37708991
OWN - NLM
STAT- MEDLINE
DCOM- 20240108
LR  - 20240108
IS  - 0003-4509 (Print)
IS  - 0003-4509 (Linking)
VI  - 82
IP  - 1
DP  - 2024 Jan
TI  - Charge variants of proposed biosimilar to Omalizumab: Isolation, purification and 
      analysis by HPLC methods.
PG  - 64-71
LID - S0003-4509(23)00106-2 [pii]
LID - 10.1016/j.pharma.2023.09.003 [doi]
AB  - Omalizumab (Xolair) is a humanized monoclonal antibody derived by recombinant DNA 
      technology. It binds specifically to immunoglobulin E (IgE) which plays a major 
      role in allergic reaction by releasing histamine and other inflammatory factors 
      from mast cells. Omalizumab binds circulatory IgE with high affinity and prevents 
      from its binding to mast cell receptor. Charge variants are one of the critical 
      quality attributes (CQAs) in biological drug development and sources of 
      heterogeneity which needs to be considered in biosimilarity assessment. In this 
      study, biosimilar product of Xolair was expressed in mammalian cell culture 
      process in laboratory to isolate charge variants (acidic, main peak and basic). 
      Different charge variants were isolated from intermediate purified biosimilar 
      product of Xolair. Isolated charge variants were purified with preparative cation 
      exchange chromatography technique and characterized with different analytical 
      tools includes size exclusion chromatography (SEC-HPLC) and cation exchange 
      chromatography (CEX-HPLC). Purity of acidic, main peak and basic variants was 
      99.58%, 99.98% and 98.64% respectively as per SEC-HPLC and according to CEX-HPLC 
      purity was 94.25%, 95.58% and 91.33% respectively. The study data indicates that 
      isolated charge variants were purified with desired purity and can be further 
      used for process characterization, in vitro potency and in vivo kinetics studies.
CI  - Copyright (c) 2023 Academie Nationale de Pharmacie. Published by Elsevier Masson 
      SAS. All rights reserved.
FAU - Gupta, Tarun
AU  - Gupta T
AD  - Institute of Science, Nirma University, 382481 Ahmedabad, Gujarat, India; 
      Downstream Process Development, Kashiv BioSciences Pvt Ltd., 382210 Ahmedabad, 
      Gujarat, India.
FAU - Seshadri, Sriram
AU  - Seshadri S
AD  - Institute of Science, Nirma University, 382481 Ahmedabad, Gujarat, India. 
      Electronic address: sriram.seshadri@nirmauni.ac.in.
LA  - eng
PT  - Journal Article
DEP - 20230912
PL  - France
TA  - Ann Pharm Fr
JT  - Annales pharmaceutiques francaises
JID - 2985176R
RN  - 2P471X1Z11 (Omalizumab)
RN  - 0 (Biosimilar Pharmaceuticals)
RN  - 37341-29-0 (Immunoglobulin E)
RN  - 0 (Cations)
SB  - IM
MH  - Animals
MH  - *Omalizumab
MH  - Chromatography, High Pressure Liquid
MH  - *Biosimilar Pharmaceuticals
MH  - Immunoglobulin E
MH  - Cations
MH  - Mammals
OTO - NOTNLM
OT  - Chromatographie
OT  - Chromatography
OT  - Des anticorps monoclonaux
OT  - Immunoglobulin E
OT  - Immunoglobuline E
OT  - Monoclonal antibodies
OT  - Potency
OT  - Puissance
OT  - Xolair
EDAT- 2023/09/15 00:42
MHDA- 2024/01/08 06:41
CRDT- 2023/09/14 19:14
PHST- 2023/08/02 00:00 [received]
PHST- 2023/09/08 00:00 [revised]
PHST- 2023/09/09 00:00 [accepted]
PHST- 2024/01/08 06:41 [medline]
PHST- 2023/09/15 00:42 [pubmed]
PHST- 2023/09/14 19:14 [entrez]
AID - S0003-4509(23)00106-2 [pii]
AID - 10.1016/j.pharma.2023.09.003 [doi]
PST - ppublish
SO  - Ann Pharm Fr. 2024 Jan;82(1):64-71. doi: 10.1016/j.pharma.2023.09.003. Epub 2023 
      Sep 12.