Zhang Y, Williams III RO, Tucker HO. Formulation strategies in immunotherapeutic pharmaceutical products. World J Clin Oncol 2020; 11(5): 275-282 [PMID: 32728530 DOI: 10.5306/wjco.v11.i5.275]
Corresponding Author of This Article
Haley Oana Tucker, PhD, Professor, Departments of Bioengineering and Molecular Biosciences, The University of Texas at Austin, 1 University Station A5000, Austin, TX 78712, United States. haleytucker@austin.utexas.edu
Research Domain of This Article
Immunology
Article-Type of This Article
Minireviews
Open-Access Policy of This Article
This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
World J Clin Oncol. May 24, 2020; 11(5): 275-282 Published online May 24, 2020. doi: 10.5306/wjco.v11.i5.275
Formulation strategies in immunotherapeutic pharmaceutical products
Yajie Zhang, Robert O Williams III, Haley Oana Tucker
Yajie Zhang, Robert O Williams III, Division of Molecular Pharmaceutics and Drug Delivery, College of Pharmacy, The University of Texas at Austin, Austin, TX 78712, United States
Haley Oana Tucker, Departments of Bioengineering and Molecular Biosciences, The University of Texas at Austin, Austin, TX 78712, United States
Author contributions: Zhang Y drafted the manuscript; Williams III RO and Tucker HO contributed in editing and modifying the paper.
Conflict-of-interest statement: Authors declare no conflict of interests for this article.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Corresponding author: Haley Oana Tucker, PhD, Professor, Departments of Bioengineering and Molecular Biosciences, The University of Texas at Austin, 1 University Station A5000, Austin, TX 78712, United States. haleytucker@austin.utexas.edu
Received: January 19, 2020 Peer-review started: January 19, 2020 First decision: April 12, 2020 Revised: May 5, 2020 Accepted: May 12, 2020 Article in press: May 12, 2020 Published online: May 24, 2020
Abstract
Development of immunologic-based biopharmaceutical products have strikingly increased in recent years and have made evident contributions to human health. Antibodies are the leading entity in immunotherapy, while chimeric antigen receptor T cells therapies are the advent of a novel strategy in this area. In order to enable antibody candidates or cells available as products, formulation is critical in terms of stabilize molecules or cells to achieve practical shelf life, storage and handling conditions. Here we provide a concise and contemporary review of ongoing formulation strategies and excipients used in approved antibodies and cellular therapeutic products. Excipients are categorized, and their function in formulations are discussed.
Core tip: In this review, we have focused on the formulation strategies and excipients that have been used in commercialized antibody products as well as the formulation concerns for immuno-cell therapy. Development of immunologic-based biopharmaceutical products have strikingly increased in recent years and have made evident contributions to human health. Antibodies are the leading entity in immunotherapy, while chimeric antigen receptor T cells therapies are the advent of a novel strategy in this area.
