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Roadmap for implementation of quality by design (QbD) for biotechnology products

Trends in biotechnology (Regular ed.), 2009-09, Vol.27 (9), p.546-553

Rathore, Anurag S

2009

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High‐throughput capillary electrophoresis analysis of biopharmaceuticals utilizing sequential injections

Electrophoresis, 2023-05, Vol.44 (9-10), p.767-774

2023

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Rapid analysis of titer, aggregate, and intact mass of antibody therapeutics using automated multi‐dimensional liquid chromatography coupled with native mass spectroscopy

Journal of separation science, 2023-07, Vol.46 (13), p.e2201050-n/a

2023

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Glycosylation of monoclonal antibody products: Current status and future prospects

Biotechnology progress, 2016-09, Vol.32 (5), p.1091-1102

2016

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Freeze thaw and lyophilization induced alteration in mAb therapeutics: Trastuzumab as a case study

Journal of pharmaceutical and biomedical analysis, 2021-07, Vol.201, p.114122-114122, Article 114122

2021

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Circular Dichroism Spectroscopy as a Tool for Monitoring Aggregation in Monoclonal Antibody Therapeutics

Analytical chemistry (Washington), 2014-12, Vol.86 (23), p.11606-11613

2014

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An accelerated approach for mechanistic model based prediction of linear gradient elution ion-exchange chromatography of proteins

Journal of Chromatography A, 2022-09, Vol.1680, p.463423, Article 463423

2022

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MADR-Net: multi-level attention dilated residual neural network for segmentation of medical images

Scientific reports, 2024-06, Vol.14 (1), p.12699-12699, Article 12699

2024

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LC-MS based case-by-case analysis of the impact of acidic and basic charge variants of bevacizumab on stability and biological activity

Scientific reports, 2021-01, Vol.11 (1), p.2487-2487, Article 2487

2021

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Post‐refolding stability considerations for optimization of in‐vitro refolding: L‐asparaginase as a case study

Biotechnology journal, 2023-04, Vol.18 (4), p.e2200505-n/a

2023

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Bioprocess Control: Current Progress and Future Perspectives

Life (Basel, Switzerland), 2021-06, Vol.11 (6), p.557

2021

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An aptamer based microfluidic chip for impedimetric detection of Ranibizumab in a bioreactor

Sensors and actuators. B, Chemical, 2020-06, Vol.312, p.127941, Article 127941

2020

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Aggregation Kinetics for IgG1-Based Monoclonal Antibody Therapeutics

The AAPS journal, 2016-05, Vol.18 (3), p.689-702

2016

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Optimization of Process Parameters for Enhanced Production of Ranibizumab in Escherichia coli

Biotechnology and Bioprocess Engineering, 2023, 28(3), , pp.386-397

2023

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Structure-Based Design of Small Peptide Ligands to Inhibit Early-Stage Protein Aggregation Nucleation

Journal of chemical information and modeling, 2020-06, Vol.60 (6), p.3304-3314

2020

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A novel piperazine derivative that targets hepatitis B surface antigen effectively inhibits tenofovir resistant hepatitis B virus

Scientific reports, 2021-06, Vol.11 (1), p.11723-13, Article 11723

2021

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Novel semi-automated fluorescence microscope imaging algorithm for monitoring IgG aggregates in serum

Scientific reports, 2021-05, Vol.11 (1), p.11375-11375, Article 11375

2021

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Analytical Similarity Assessment of Biosimilars: Global Regulatory Landscape, Recent Studies and Major Advancements in Orthogonal Platforms

Frontiers in bioengineering and biotechnology, 2022-02, Vol.10, p.832059-832059

2022

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Preparative Chromatography for Separation of Proteins

1, 2017

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Enablers for QbD implementation: Mechanistic modeling for ion-exchange membrane chromatography

Journal of membrane science, 2016-02, Vol.500, p.86-98

2016

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

Journal of Chromatography Open, 2024-05, Vol.5, p.100107, Article 100107

2024

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Continuous Processing for Production of Biopharmaceuticals

Preparative biochemistry & biotechnology, 2015-11, Vol.45 (8), p.836-849

2015

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Supplementation of critical amino acids improves glycerol and lactose uptake and enhances recombinant protein production in Escherichia coli

Biotechnology journal, 2021-08, Vol.16 (8), p.n/a

2021

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Quality by design for biopharmaceuticals: principles and case studies

1st ed., 2009

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Quality by design for biopharmaceuticals

Nature biotechnology, 2009-01, Vol.27 (1), p.26-34

2009

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Roadmap for implementation of quality by design (QbD) for biotechnology products

High‐throughput capillary electrophoresis analysis of biopharmaceuticals utilizing sequential injections

Rapid analysis of titer, aggregate, and intact mass of antibody therapeutics using automated multi‐dimensional liquid chromatography coupled with native mass spectroscopy

Glycosylation of monoclonal antibody products: Current status and future prospects

Freeze thaw and lyophilization induced alteration in mAb therapeutics: Trastuzumab as a case study

Circular Dichroism Spectroscopy as a Tool for Monitoring Aggregation in Monoclonal Antibody Therapeutics

An accelerated approach for mechanistic model based prediction of linear gradient elution ion-exchange chromatography of proteins

MADR-Net: multi-level attention dilated residual neural network for segmentation of medical images

LC-MS based case-by-case analysis of the impact of acidic and basic charge variants of bevacizumab on stability and biological activity

Post‐refolding stability considerations for optimization of in‐vitro refolding: L‐asparaginase as a case study

Bioprocess Control: Current Progress and Future Perspectives

An aptamer based microfluidic chip for impedimetric detection of Ranibizumab in a bioreactor

Aggregation Kinetics for IgG1-Based Monoclonal Antibody Therapeutics

Optimization of Process Parameters for Enhanced Production of Ranibizumab in Escherichia coli

Structure-Based Design of Small Peptide Ligands to Inhibit Early-Stage Protein Aggregation Nucleation

A novel piperazine derivative that targets hepatitis B surface antigen effectively inhibits tenofovir resistant hepatitis B virus

Novel semi-automated fluorescence microscope imaging algorithm for monitoring IgG aggregates in serum

Analytical Similarity Assessment of Biosimilars: Global Regulatory Landscape, Recent Studies and Major Advancements in Orthogonal Platforms

Preparative Chromatography for Separation of Proteins

Enablers for QbD implementation: Mechanistic modeling for ion-exchange membrane chromatography

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

Continuous Processing for Production of Biopharmaceuticals

Supplementation of critical amino acids improves glycerol and lactose uptake and enhances recombinant protein production in Escherichia coli

Quality by design for biopharmaceuticals: principles and case studies

Quality by design for biopharmaceuticals

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