Advanced search
Publication Cover
mAbs Volume 11, 2019 - Issue 4
Submit an article Journal homepage
2,546
Views
12
CrossRef citations to date
0
Altmetric
Report

Process optimization and protein engineering mitigated manufacturing challenges of a monoclonal antibody with liquid-liquid phase separation issue by disrupting inter-molecule electrostatic interactions

Qun DuDepartment of Antibody Discovery and Protein Engineering, AstraZeneca, Gaithersburg, MD, USAORCID Iconhttps://orcid.org/0000-0001-8239-0927
ORCID Icon,
Melissa DamschroderDepartment of Antibody Discovery and Protein Engineering, AstraZeneca, Gaithersburg, MD, USAORCID Iconhttps://orcid.org/0000-0001-9453-6532
ORCID Icon,
Timothy M. PabstPurification Process Sciences, AstraZeneca, Gaithersburg, MD, USAORCID Iconhttps://orcid.org/0000-0001-6961-8472
ORCID Icon,
Alan K. HunterPurification Process Sciences, AstraZeneca, Gaithersburg, MD, USA
,
William K. WangPurification Process Sciences, AstraZeneca, Gaithersburg, MD, USA
&
Haibin LuoPurification Process Sciences, AstraZeneca, Gaithersburg, MD, USACorrespondence[email protected] [email protected]
ORCID Iconhttps://orcid.org/0000-0001-5964-567X
ORCID Icon
Pages 789-802 | Received 07 Jan 2019, Accepted 22 Mar 2019, Published online: 14 Apr 2019

Citations (12)

Keep up to date with the latest research on this topic with citation updates for this article.

Subscribe to citation updates

Read on this site (2)

Jack E. Bramham, Stephanie A. Davies, Adrian Podmore & Alexander P. Golovanov. (2021) Stability of a high-concentration monoclonal antibody solution produced by liquid–liquid phase separation. mAbs 13:1.
Read now
Robert J. Benschop, Chi-Kin Chow, Yu Tian, James Nelson, Barbra Barmettler, Shane Atwell, David Clawson, Qing Chai, Bryan Jones, Jon Fitchett, Stacy Torgerson, Yan Ji, Holly Bina, Ningjie Hu, Mahmoud Ghanem, Joseph Manetta, Victor J. Wroblewski, Jirong Lu & Barrett W. Allan. (2019) Development of tibulizumab, a tetravalent bispecific antibody targeting BAFF and IL-17A for the treatment of autoimmune disease. mAbs 11:6, pages 1175-1190.
Read now

Articles from other publishers (10)

Junhe Ma, Charles Pathirana, David Q. Liu & Scott A. Miller. (2023) NMR spectroscopy as a characterization tool enabling biologics formulation development. Journal of Pharmaceutical and Biomedical Analysis 223, pages 115110.
Crossref
Hannes Ausserwöger, Matthias M. Schneider, Therese W. Herling, Paolo Arosio, Gaetano Invernizzi, Tuomas P. J. Knowles & Nikolai Lorenzen. (2022) Non-specificity as the sticky problem in therapeutic antibody development. Nature Reviews Chemistry 6:12, pages 844-861.
Crossref
Haibin Luo, Qun Du, Chen Qian, Michelle Mlynarczyk, Timothy M. Pabst, Melissa Damschroder, Alan K. Hunter & William K. Wang. (2022) Formation of transient highly-charged mAb clusters strengthens interactions with host cell proteins and results in poor clearance of host cell proteins by protein A chromatography. Journal of Chromatography A 1679, pages 463385.
Crossref
Subhabrata Majumder, Deep S. Bhattacharya, Alex Langford & Arun Alphonse Ignatius. (2022) Utility of High Resolution 2D NMR Fingerprinting in Assessing Viscosity of Therapeutic Monoclonal Antibodies. Pharmaceutical Research 39:3, pages 529-539.
Crossref
Douglas D. Banks & Jon F. Cordia. (2021) Suppression of Electrostatic Mediated Antibody Liquid–Liquid Phase Separation by Charged and Noncharged Preferentially Excluded Excipients. Molecular Pharmaceutics 18:3, pages 1285-1292.
Crossref
Wei Qi, Larysa Alekseychyk, Noi Nuanmanee, Deniz B. Temel, Victoria Jann, Mike Treuheit & Vladimir Razinkov. (2021) Resolving Liquid-Liquid Phase Separation for a Peptide Fused Monoclonal Antibody by Formulation Optimization. Journal of Pharmaceutical Sciences 110:2, pages 738-745.
Crossref
Éva Kollár, Boglárka Balázs, Tímea Tari & István Siró. (2020) Development challenges of high concentration monoclonal antibody formulations. Drug Discovery Today: Technologies 37, pages 31-40.
Crossref
Tatsuji Matsuoka, Ryuki Miyauchi, Nobumi Nagaoka & Jun Hasegawa. (2020) Mitigation of liquid–liquid phase separation of a monoclonal antibody by mutations of negative charges on the Fab surface. PLOS ONE 15:10, pages e0240673.
Crossref
Manali S. Sawant, Craig N. Streu, Lina Wu & Peter M. Tessier. (2020) Toward Drug-Like Multispecific Antibodies by Design. International Journal of Molecular Sciences 21:20, pages 7496.
Crossref
Haibin Luo, Qun Du, Chen Qian, Michelle Mlynarczyk, Timothy M. Pabst, Melissa Damschroder, Alan K. Hunter & William K. Wang. (2022) Formation of Transient Highly-Charged Mab Clusters Strengthens Interactions with Host Cell Proteins (Hcps) and Results in Poor Hcp Removal by Protein a Chromatography. SSRN Electronic Journal.
Crossref

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Order Reprints Request Corporate Permissions

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

Request Academic Permissions

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.

Related research

People also read lists articles that other readers of this article have read.

Recommended articles lists articles that we recommend and is powered by our AI driven recommendation engine.

Cited by lists all citing articles based on Crossref citations.
Articles with the Crossref icon will open in a new tab.