Literature DB >> 22900469

High-dose monoclonal antibodies via the subcutaneous route: challenges and technical solutions, an industry perspective.

Chakravarthy Narasimhan1, Henryk Mach, Mohammed Shameem.   

Abstract

This review summarizes the various challenges in product development involved in subcutaneous administration of high-dose monoclonal antibodies and attempts to provide an industry perspective of some of the available technologies and potential avenues to overcome these challenges.

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Year:  2012        PMID： 22900469     DOI： 10.4155/tde.12.68

Source DB:  PubMed          Journal:  Ther Deliv        ISSN： 2041-5990


  11 in total

1.  Rational design of viscosity reducing mutants of a monoclonal antibody: hydrophobic versus electrostatic inter-molecular interactions.

Authors:  Pilarin Nichols; Li Li; Sandeep Kumar; Patrick M Buck; Satish K Singh; Sumit Goswami; Bryan Balthazor; Tami R Conley; David Sek; Martin J Allen
Journal:  MAbs       Date:  2015       Impact factor: 5.857

Review 2.  Structure, heterogeneity and developability assessment of therapeutic antibodies.

Authors:  Yingda Xu; Dongdong Wang; Bruce Mason; Tony Rossomando; Ning Li; Dingjiang Liu; Jason K Cheung; Wei Xu; Smita Raghava; Amit Katiyar; Christine Nowak; Tao Xiang; Diane D Dong; Joanne Sun; Alain Beck; Hongcheng Liu
Journal:  MAbs       Date:  2018-12-17       Impact factor: 5.857

3.  Challenges in Predicting Protein-Protein Interactions from Measurements of Molecular Diffusivity.

Authors:  Lea L Sorret; Madison A DeWinter; Daniel K Schwartz; Theodore W Randolph
Journal:  Biophys J       Date:  2016-11-01       Impact factor: 4.033

Review 4.  Non-invasive delivery strategies for biologics.

Authors:  Aaron C Anselmo; Yatin Gokarn; Samir Mitragotri
Journal:  Nat Rev Drug Discov       Date:  2018-11-30       Impact factor: 84.694

5.  Concentration dependent viscosity of monoclonal antibody solutions: explaining experimental behavior in terms of molecular properties.

Authors:  Li Li; Sandeep Kumar; Patrick M Buck; Christopher Burns; Janelle Lavoie; Satish K Singh; Nicholas W Warne; Pilarin Nichols; Nicholas Luksha; Davin Boardman
Journal:  Pharm Res       Date:  2014-06-07       Impact factor: 4.200

6.  Multiphysics Modeling and Simulation of Subcutaneous Injection and Absorption of Biotherapeutics: Sensitivity Analysis.

Authors:  Peng Hou; Fudan Zheng; Clairissa D Corpstein; Lei Xing; Tonglei Li
Journal:  Pharm Res       Date:  2021-06-02       Impact factor: 4.200

Review 7.  Early implementation of QbD in biopharmaceutical development: a practical example.

Authors:  Jesús Zurdo; Andreas Arnell; Olga Obrezanova; Noel Smith; Ramón Gómez de la Cuesta; Thomas R A Gallagher; Rebecca Michael; Yvette Stallwood; Caroline Ekblad; Lars Abrahmsén; Ingmarie Höidén-Guthenberg
Journal:  Biomed Res Int       Date:  2015-05-17       Impact factor: 3.411

8.  Web-based display of protein surface and pH-dependent properties for assessing the developability of biotherapeutics.

Authors:  Max Hebditch; Jim Warwicker
Journal:  Sci Rep       Date:  2019-02-13       Impact factor: 4.379

9.  Evaluation of the impact of viscosity, injection volume, and injection flow rate on subcutaneous injection tolerance.

Authors:  Cecile Berteau; Orchidée Filipe-Santos; Tao Wang; Humberto E Rojas; Corinne Granger; Florence Schwarzenbach
Journal:  Med Devices (Auckl)       Date:  2015-11-11

10.  Comparison of pharmacokinetics, safety and tolerability of secukinumab administered subcutaneously using different delivery systems in healthy volunteers and in psoriasis patients.

Authors:  Gerard Bruin; Hans-Ulrich P Hockey; Phillip La Stella; Bárdur Sigurgeirsson; Rong Fu; Manmath Patekar; Pascal Charef; Ralph Woessner; Bruno Boutouyrie-Dumont
Journal:  Br J Clin Pharmacol       Date:  2020-01-07       Impact factor: 4.335
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