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1,363 results on '"Rathore, Anurag S."'

157. A novel method for continuous chromatographic separation of monoclonal antibody charge variants by combining displacement mode chromatography and step elution.

Author

Anupa, Anupa, Bansode, Vikrant, Kateja, Nikhil, and Rathore, Anurag S.

Subjects
GRADIENT elution (Chromatography), ELUTION (Chromatography), CONTINUOUS processing, MONOCLONAL antibodies, CHROMATOGRAPHIC analysis, PRODUCT quality
Abstract

Charge heterogeneity of monoclonal antibodies is considered a critical quality attribute and hence needs to be monitored and controlled by the manufacturer. Typically, this is accomplished via separation of charge variants on cation exchange chromatography (CEX) using a pH or conductivity based linear gradient elution. Although an effective approach, this is challenging particularly during continuous processing as creation of linear gradient during continuous processing adds to process complexity and can lead to deviations in product quality upon slightest changes in gradient formation. Moreover, the long length of elution gradient along with the required peak fractionation makes process integration difficult. In this study, we propose a novel approach for separation of charge variants during continuous CEX chromatography by utilizing a combination of displacement mode chromatography and salt‐based step elution. It has been demonstrated that while the displacement mode of chromatography enables control of acidic variants ≤26% in the CEX eluate, salt‐based step gradient elution manages basic charge variant ≤25% in the CEX eluate. The proposed approach has been successfully demonstrated using feed materials with varying compositions. On comparing the designed strategy with 2‐column concurrent (CC) chromatography, the resin specific productivity increased by 95% and resin utilization increased by 183% with recovery of main species >99%. Further, in order to showcase the amenability of the designed CEX method in continuous operation, the method was examined in our in‐house continuous mAb platform. [ABSTRACT FROM AUTHOR]

Published
2024
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160. Emerging themes and factors influencing the prices of biotherapeutics.

Author

Gandhi, Sonia, Kashiramka, Smita, and Rathore, Anurag S.

Subjects
PRICES, DELIVERY of goods, PRICE regulation, PROFIT margins, GOVERNMENT policy
Abstract

Copyright of World Medical & Health Policy is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Published
2023
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162. Challenges with Successful Commercialization of Biosimilars: This article presents some key differences between the US and European regulation of biosimilars, including naming conventions and pharmacovigilance of biosimilars, and the impact of biosimilars on commercialization and affordability of biotherapeutics

Author

Rathore, Anurag S., Vulto, Arnold G., Stevenson, James G., and Shah, Vinod P.

Subjects
Generic drugs, Biotechnology industry, Business, Pharmaceuticals and cosmetics industries
Abstract

Commercialization rights for novel therapeutic products are protected for a finite period by patents and other measures. After expiration of patents and other exclusivity rights, other manufacturers are allowed to [...]

Published
2019

163. Real-Time Characterization of Biotherapeutics and Comparability of Biosimilars: A major advantage of SPR-based analysis is its ability to estimate the association and dissociation rate constants, an advancement over the traditional steady-state analysis of biomolecules

Author

Rathore, Anurag S. and Dash, Rozaleen

Subjects
Biotechnology, Biochemistry, EDTA, Therapeutics, Backup software, Chronic diseases, Biotechnology industry, Business, Pharmaceuticals and cosmetics industries
Abstract

Biotherapeutics are an emerging class of treatment modalities that are manufactured using living cells. They have been successfully used for treating many life-threatening and chronic diseases. Compared to the traditional [...]

Published
2019

164. Analytical Characterization of Biotherapeutic Products Part II: The Analytical Toolbox: In the first part of this series, we discussed the various quality attributes that are pertinent to a biotherapeutic. In this issue, we will present the current and evolving practices that are being used for analysis of these attributes

Author

Rathore, Anurag S., Krull, Ira S., and Joshi, Srishti

Subjects
Chemistry
Abstract

With increasing importance being attached to structural attributes of biotherapeutics and subsequent biosimilars, the analytical techniques used for characterizing these attributes have also evolved. There is an ever-increasing interest in [...]

Published
2018

165. Modeling the Degradation of mAb Therapeutics: Kinetic models can be used to study aggregation and fragmentation to help ensure stability

Author

Rathore, Anurag S. and Bansal, Rohit

Subjects
Monoclonal antibodies -- Physiological aspects, Biological products -- Physiological aspects, Product development -- Physiological aspects, Proteins -- Physiological aspects, Backup software, Antibodies, Biopharmaceuticals, Time to market, Biotechnology industry, Business, Pharmaceuticals and cosmetics industries
Abstract

Ensuring the stability of biotherapeutic products, which has an impact on their safety and efficacy, continues to be a major challenge for the biopharmaceutical industry. This is particularly true for [...]

Published
2019

182. Contributors

Author

Abraham, Amith, primary, Adhikari, Sushil, additional, Ahmad, Ejaz, additional, Azuma, Jun-ichi, additional, Badgujar, Kirtikumar C., additional, Bastidas-Oyanedel, Juan-Rodrigo, additional, Batra, Jyoti, additional, Bhanage, Bhalchandra M., additional, Bhaskar, Thallada, additional, Bordoloi, Neonjyoti, additional, Butti, Sai K., additional, Chakraborty, Jyoti P., additional, Chandolias, Konstantinos, additional, Chang, Jo-Shu, additional, Choi, Gyung-Goo, additional, Chopda, Viki R., additional, Chutia, Rahul S., additional, de Melo, Eduardo M., additional, Dhyani, Vaibhav, additional, Dole, Bhushan R., additional, Domingues, Lucília, additional, Fujii, Satoshi, additional, Gomes, James, additional, Goyal, Arun, additional, Grewal, Jasneet, additional, Houghton, Joseph A., additional, Kataki, Rupam, additional, Kathiresan, P., additional, Khanal, Samir K., additional, Khare, Sunil K., additional, Kim, Joo-Sik, additional, Kirtania, Kawnish, additional, Konwar, Lakhya J., additional, Maesara, Sausan A., additional, Mallapureddy, Kiran Kumar, additional, Martinez-Hernandez, Elias, additional, Matharu, Avtar S., additional, Mathew, Anil K., additional, Michelin, Michele, additional, Mikkola, Jyri-Pekka, additional, Mohanakrishna, Gunda, additional, Moholkar, Vijayanand S., additional, Nagarajan, Dillirani, additional, Naik, Satya N., additional, Nam, Hyungseok, additional, Ojha, Deepak K., additional, Pant, Kamal K., additional, Pant, Deepak, additional, Patil, Sunil A., additional, Rajendran, Karthik, additional, Rathore, Anurag S., additional, Richards, Tobias, additional, Romaní, Aloia, additional, Sadaf, Ayesha, additional, Sadhukhan, Jhuma, additional, Saikia, Ruprekha, additional, Sankaran, Revathy, additional, Sarkar, Omprakash, additional, Saxena, Devesh K., additional, Schmidt, Jens Ejbye, additional, Seelam, Jai Sankar, additional, Show, Pau L., additional, Singh, Rawel, additional, Singh, Shuchi, additional, Sukumaran, Rajeev K., additional, Surendra, K.C., additional, Tabata, Tomohiro, additional, Taherzadeh, Mohammad J., additional, Teixeira, José A., additional, ter Heijne, Annemiek, additional, Thallada, Bhaskar, additional, Tomberlin, Jeffery K., additional, Tran, Khanh-Quang, additional, Tsubaki, Shuntaro, additional, Mohan, S. Venkata, additional, Vinu, Ravikrishnan, additional, Wada, Yuji, additional, and Zhang, Zhanrong, additional

Published
2018
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183. Contributors

Author

Armando, John W., primary, Atkinson, E. Morrey, additional, Bernhardt, Peter, additional, Blank, Torbjörn S., additional, Brady, Yvonne A., additional, Brekkan, Eggert, additional, Buchacher, Andrea, additional, Busson, Karolina, additional, Caparon, Maire H., additional, Carredano, Enrique N., additional, Carter, Jeffrey R., additional, Castan, Andreas, additional, Chen, Shuang, additional, Clapp, Kenneth P., additional, Cook, Scott A., additional, Cundy, John T., additional, Curling, John M., additional, Danielsson, Åke, additional, Eriksson, Kjell O., additional, Fairbank, Alain, additional, Farid, Suzanne S., additional, Fischer, Simon, additional, Frej, Kine A.-K., additional, Galliher, Parrish M., additional, Gebauer, Klaus, additional, Giese, Glen S., additional, Gilbert, Alan, additional, Grönberg, Anna, additional, Gröner, Albrecht, additional, Gronke, Robert S., additional, Hall, Martin, additional, Hejnaes, Kim R., additional, Hendricks, Rachel S., additional, Hjorth, Rolf A., additional, Hodge, Geoff, additional, Hutchinson, Matt H., additional, Jagschies, Günter, additional, Jenkins, Michael J., additional, Johansson, Mikael I., additional, Joseph, John, additional, Kaltenbrunner, Oliver, additional, Kapoor, Gautam, additional, Karlsson, Tomas M., additional, Kelley, Brian D., additional, Kleinjans, Annika, additional, Kumar, Jashwant, additional, Łącki, Karol M., additional, Lester, Philip, additional, Liderfelt, Jakob, additional, Lin, Xin Xin, additional, Lindskog, Eva K., additional, Lundgren, Mats, additional, Mangalath-Illam, Ratish, additional, Marshall, Trevor J., additional, Martin, Joseph P., additional, Mehta, Krunal K., additional, Montgomery, Brian, additional, Nelson, Daniel, additional, Nordberg, Roger, additional, Olson, Dana A., additional, Östling, Martin, additional, Pieracci, John P., additional, Pollard, David J., additional, Pralong, Alain, additional, Pujar, Hari, additional, Quaadgras, Joost P., additional, Ransohoff, Tom C., additional, Rathore, Anurag S., additional, Robinson, Craig, additional, Royce, Jonathan, additional, Rubacha, Michael A., additional, Sandegren, Henrik, additional, Schaubmar, Andreas, additional, Schulz, Patrick, additional, Singh, Sumit K., additional, Sobacke, Stephen E., additional, Srinivasan, Sriram, additional, Stork, Matthew J., additional, Tangarone, Bruce S., additional, Thommes, Jorg, additional, Traylor, Matthew J., additional, Tschöp, Johan, additional, Van Alstine, James M., additional, Varghese, Johnson, additional, Vedantham, Ganesh, additional, von Hirschheydt, Thomas, additional, Wellborn, William B., additional, Wenger, Till, additional, Westin, Susanne, additional, Westman, David G., additional, Westoby, Matthew, additional, Whitford, William G., additional, Williams, Ambrose J., additional, and Woodgate, John M., additional

Published
2018
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187. An efficient computational protocol for template‐based design of peptides that inhibit interactions involving SARS‐CoV‐2 proteins.

Author

Chenna, Akshay, Khan, Wajihul Hasan, Dash, Rozaleen, Saraswat, Saurabh, Chugh, Archana, Rathore, Anurag S., and Goel, Gaurav

Abstract

The RNA‐dependent RNA polymerase (RdRp) complex of SARS‐CoV‐2 lies at the core of its replication and transcription processes. The interfaces between holo‐RdRp subunits are highly conserved, facilitating the design of inhibitors with high affinity for the interaction interface hotspots. We, therefore, take this as a model protein complex for the application of a structural bioinformatics protocol to design peptides that inhibit RdRp complexation by preferential binding at the interface of its core subunit nonstructural protein, nsp12, with accessory factor nsp7. Here, the interaction hotspots of the nsp7‐nsp12 subunit of RdRp, determined from a long molecular dynamics trajectory, are used as a template. A large library of peptide sequences constructed from multiple hotspot motifs of nsp12 is screened in‐silico to determine sequences with high geometric complementarity and interaction specificity for the binding interface of nsp7 (target) in the complex. Two lead designed peptides are extensively characterized using orthogonal bioanalytical methods to determine their suitability for inhibition of RdRp complexation. Binding affinity of these peptides to accessory factor nsp7, determined using a surface plasmon resonance (SPR) assay, is slightly better than that of nsp12: dissociation constant of 133nM and 167nM, respectively, compared to 473nM for nsp12. A competitive ELISA is used to quantify inhibition of nsp7‐nsp12 complexation, with one of the lead peptides giving an IC50 of 25μM. Cell penetrability and cytotoxicity are characterized using a cargo delivery assay and MTT cytotoxicity assay, respectively. Overall, this work presents a proof‐of‐concept of an approach for rational discovery of peptide inhibitors of SARS‐CoV‐2 protein–protein interactions. [ABSTRACT FROM AUTHOR]

Published
2023
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197. Transcriptomics and the Production of Recombinant Therapeutics: Transcriptomics plays a role in influencing the production of recombinant therapeutics in microbial and mammalian hosts

Author

Rathore, Anurag S. and Chauhan, Ashish

Subjects
Genetic engineering -- Genetic aspects, Genes -- Genetic aspects, Transcription (Genetics) -- Genetic aspects, Amino acids -- Genetic aspects, Diabetes therapy, Genomics -- Genetic aspects, Antiarthritic agents, RNA -- Genetic aspects, Biotechnology industry, Business, Pharmaceuticals and cosmetics industries
Abstract

Various recombinant therapeutics are available for treatment of arthritis, inflammation, immune disorders, central neural system, diabetes and endocrinology, genetic disorders, hematology, infectious diseases including HIV, and oncology. A significant development [...]

Published
2018

198. Preclinical Evaluation of Product Related Impurities and Variants: The approaches for sample preparation of preclinical evaluation of safety and efficacy are addressed taking into consideration the shortcoming with the contemporary approaches

Author

Rathore, Anurag S., Yadav, Dinesh K., Pandey, Shyam S., Singh, Sumit K., and Kumar, Deepak

Subjects
Clinical trials -- Safety and security measures, Granulocyte colony-stimulating factor -- Testing -- Health aspects, Monoclonal antibodies -- Testing -- Health aspects, Biotechnology industry, Business, Pharmaceuticals and cosmetics industries
Abstract

Biotherapeutics are an emerging class of treatment that are produced by harnessing the protein synthetic machinery of living cells (1). These drugs have become the centerpiece of biotechnology industry and [...]

Published
2018

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