Sanghati Bhattacharya

University of Iowa

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Anurag S. Rathore

Indian Institute of Technology Delhi

Arnab Sen

North Bengal University

Deepika Sarin

Indian Institute of Technology Delhi

Saxena Nikita

Indian Institute of Technology Delhi

Srishti Joshi

Indian Institute of Technology Delhi

Krishna Mohan Medicherla

Birla Institute of Scientific Research

Raj Suryanarayanan

University of Minnesota

Neh Nupur

Indian Institute of Technology Delhi

Vadim J. Gurvich

University of Minnesota

Rabia Parveen

M.J.P. Rohilkhand University

Cooperative Institutions

Birla Institute of Scientific Research

Indian Institute of Technology Delhi

Amrita Vishwa Vidyapeetham

Guru Gobind Singh Indraprastha University

Vignan's Foundation for Science, Technology & Research

Vidyasagar University

North Bengal University

Sawai ManSingh Medical College and Hospital

University of Minnesota

Institute of Medical Sciences

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Two-Dimensional Liquid Chromatography (2D-LC): Analysis of Size-Based Heterogeneities in Monoclonal Antibody–Based Biotherapeutic Products

LCGC North America (2022)

Sanghati Bhattacharya Deepika Sarin

Monoclonal antibodies (mAbs) dominate the pipelines in the biopharmaceutical industry today. Being complex products, this class of molecules has numerous critical quality attributes (CQAs). Their thorough characterization is a necessary and critical component of biopharmaceutical product development. One CQA is size-based heterogeneity. Aggregates are widely considered a CQA because of their likely impact on the immunogenicity of the product. There is no single analytical tool that can accurately characterize aggregates because of the significant diversity that they exhibit with respect to size, structure, and morphology. As a result, it is common practice to use multiple, orthogonal analytical tools for aggregate characterization. This article reviews efforts targeting the use of two-dimensional liquid chromatography (2D-LC) and mass spectrometry (MS) for aggregate characterization.

Biopharmaceutical

Critical quality attributes

Characterization

10.56530/lcgc.na.cz9881a2

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Citations (5)

A native multi-dimensional monitoring workflow for at-line characterization of mAb titer, size, charge, and glycoform heterogeneities in cell culture supernatant

Journal of Chromatography A (2023)

Sanghati Bhattacharya Srishti Joshi Anurag S. Rathore

Characterization

Biopharmaceutical

10.1016/j.chroma.2023.463983

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Citations (8)

Taking the individual bias out of examining comparability of biosimilars: A case study on monoclonal antibody therapeutics

International Journal of Biological Macromolecules (2022)

Anurag S. Rathore Srishti Joshi Neh Nupur Saxena Nikita Sanghati Bhattacharya

Biosimilar

Comparability

Plot (graphics)

Critical quality attributes

Similarity (geometry)

10.1016/j.ijbiomac.2022.12.011

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Citations (3)

Multi-attribute monitoring applications in biopharmaceutical analysis

Journal of Chromatography Open (2024)

Anurag S. Rathore Deepika Sarin Sanghati Bhattacharya Sunil Kumar

Since the introduction of Quality by Design for production of biopharmaceuticals, the global biopharma industry has been advancing towards developing highly efficient and sensitive platforms for monitoring product quality attributes. Incorporating mass-spectrometry-based multi-attribute monitoring (MAM) as a novel tool for identifying and characterizing post-translational modifications in biotherapeutics has gained increasing traction. The ability of MAM to monitor multiple critical quality attributes coupled with new peak detection functions in a single workflow is highly desirable to the biopharmaceutical industry. This review examines and discusses the evolution and adaptation of MAM for routine product quality assessment. MAM applications in biotherapeutic characterization, comparability, and chemometrics have also been discussed, along with the gaps and future perspectives of the MAM implementation in biopharmaceutical drug development. Primary focus has been kept on major developments in last 6 years (2018–2024).

Biopharmaceutical

Quality by Design

Comparability

10.1016/j.jcoa.2024.100166

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Citations (0)

Reversed phase high performance liquid chromatography for monitoring type-16 human papilloma virus like particles

Journal of Chromatography Open (2023)

Vineela Peruri Sanghati Bhattacharya Anurag S. Rathore

Quantification of virus like particles (VLPs) is challenging due to the large size and structural heterogeneity of the molecule. Structural heterogeneity arises due to random assemblage of L1 protein with other host cell proteins. With multiple VLPs under development as potential biotherapeutic products, defining their identity, purity and potency is of great interest. Most analytical methods used at present for VLP quantification are laborious and at best semi-quantitative. Thus, there is a need for an analytical technique that is capable of quantitatively estimating both purity and titre at all stages of the process. In this study, we propose use of Reversed phase chromatography for separation and identification of VLP L1 proteins in inhouse crude and purified samplesand quantification of L1 protein at different process points. The proposed method takes about 20 minutes and has been demonstrated to be highly sensitive, robust, and selective, as confirmed through mass spectrometry.

10.1016/j.jcoa.2023.100107

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Citations (3)

Characterization of haemoglobin from Actinorhizal plants – An in silico approach

Journal of Biosciences (2013)

Sanghati Bhattacharya Arnab Sen Subarna Thakur Louis S. Tisa

Actinorhizal plant

Leghemoglobin

Casuarina

Frankia

Homology

10.1007/s12038-013-9357-0

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Citations (4)

A Database for Mycobacterium Secretome Analysis: ‘MycoSec’ to Accelerate Global Health Research

OMICS A Journal of Integrative Biology (2013)

Ayan Roy Sanghati Bhattacharya Asim Bothra Arnab Sen

Abstract Members of the genus Mycobacterium are notorious for their pathogenesis. Investigations from various perspectives have identified the pathogenic strategies employed by these lethal pathogens. Secretomes are believed to play crucial roles in host cell recognition and cross-talks, in cellular attachment, and in triggering other functions related to host pathogen interactions. However, a proper idea of the mycobacterial secretomes and their mechanism of functionality still remains elusive. In the present study, we have developed a comprehensive database of potential mycobacterial secretomes (MycoSec) using pre-existing algorithms for secretome prediction for researchers interested in this particular field. The database provides a platform for retrieval and analysis of identified secretomes in all finished genomes of the family Mycobacteriaceae. The database contains valuable information regarding secretory signal peptides (Sec type), lipoprotein signal peptides (Lipo type), and Twin arginine (RR/KR) signal peptides (TAT type), prevalent in mycobacteria. Information pertaining to COG analysis, codon usage, and gene expression of the predicted secretomes has also been incorporated in the database. MycoSec promises to be a useful repertoire providing a plethora of information regarding mycobacterial secretomes and may well be a platform to speed global health research. MycoSec is freely accessible at http://www.bicnbu.in/mycosec .

Global Health

10.1089/omi.2013.0015

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Citations (10)

A novel filter-assisted protein precipitation (FAPP) based sample pre-treatment method for LC-MS peptide mapping for biosimilar characterization

Journal of Pharmaceutical and Biomedical Analysis (2023)

Sanghati Bhattacharya Anurag S. Rathore

Sample Preparation

Protein precipitation

Digestion

10.1016/j.jpba.2023.115527

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