Multiplexed Microfluidic Cartridge for At-Line Protein Monitoring in Mammalian Cell Culture Processes for Biopharmaceutical Production DOI Creative Commons
Inês F. Pinto, Ruben R. G. Soares, Meeri Mäkinen

et al.

ACS Sensors, Journal Year: 2021, Volume and Issue: 6(3), P. 842 - 851

Published: March 16, 2021

The biopharmaceutical market has been rapidly growing in recent years, creating a highly competitive arena where R&D is critical to strike balance between clinical safety and profitability. Toward process optimization, the development adoption of new analytical technologies (PAT) highlight dynamic complexity mammalian/human cell culture processes, as well importance fine-tuning modeling key metabolites proteins. In this context, simple, rapid, cost-effective devices allowing routine at-line monitoring specific proteins during production are currently lacking. Here, we report versatile microfluidic protein analysis cartridge multiplexed bead-based immunodetection directly from complex mixtures with minimal hands-on time. Colorimetric quantification Chinese hamster ovary (CHO) host impurities, monoclonal antibodies target biopharmaceuticals, lactate dehydrogenase marker viability was achieved limits detection 1–10 ng/mL range times short 30 min. device further demonstrated for Rituximab-producing CHO bioreactor over course 8 days, providing comparable recoveries standard enzyme-linked immunosorbent assay (ELISA) kits. high sensitivity combined robustness matrix interference highlights potential perform measurements spanning downstream processing.

Language: Английский

Polymers for cytosolic protein delivery DOI
Jia Lv, Qianqian Fan, Hui Wang

et al.

Biomaterials, Journal Year: 2019, Volume and Issue: 218, P. 119358 - 119358

Published: July 15, 2019

Language: Английский

Citations

235

Phage Display Derived Monoclonal Antibodies: From Bench to Bedside DOI Creative Commons
Mohamed A. Alfaleh, Hashem O. Alsaab, Ahmad Bakur Mahmoud

et al.

Frontiers in Immunology, Journal Year: 2020, Volume and Issue: 11

Published: Aug. 28, 2020

Monoclonal antibodies (mAbs) have become one of the most important classes biopharmaceutical products, and they continue to dominate universe markets in terms approval sales. They are profitable single product class, where represent six top ten selling drugs. At beginning 1990s, an vitro antibody selection technology known as phage display was developed by John McCafferty Sir. Gregory Winter that enabled discovery human for diverse applications, particularly antibody-based created combinatorial libraries on filamentous be utilized generating antigen specific a matter weeks. Since then, more than 70 phage–derived entered clinical studies 14 them been approved. These indicated cancer, non-cancer medical conditions, such inflammatory, optical, infectious, or immunological diseases. Antibody has proven powerful, versatile platform development. This review will illustrate utility powerful therapeutic describe detail all approved mAbs derived from display.

Language: Английский

Citations

213

Natural polyphenols in drug delivery systems: Current status and future challenges DOI Creative Commons
Hui Wang, Changping Wang, Yuan Zou

et al.

Giant, Journal Year: 2020, Volume and Issue: 3, P. 100022 - 100022

Published: Aug. 1, 2020

Natural polyphenols have attracted great interests in medicine, food and cosmetics due to their versatile functions such as antioxidant, anticancer antibacterial. The polyphenolic structures (i.e. catechol, pyrogallol) natural are responsible for strong noncovalent interactions via multiple hydrogen bonding hydrophobic interactions, dynamic covalent complexation with boronate groups metal ions. In this review, we focused on the preparation applications of polyphenol-based coating films, nanoparticles, nanocapsules, hydrogels emerged from chemical functional signatures. beneficial role mechanism facilitating delivery proteins, nucleic acids conventional drug molecules were reviewed. Finally, challenges systems perspectives rational design next generation polyphenol biomaterials will be discussed.

Language: Английский

Citations

162

Therapeutic Fc‐fusion proteins: Current analytical strategies DOI

Bastiaan L. Duivelshof,

Amarande Murisier,

Julien Camperi

et al.

Journal of Separation Science, Journal Year: 2020, Volume and Issue: 44(1), P. 35 - 62

Published: Sept. 22, 2020

Fc-Fusion proteins represent a successful class of biopharmaceutical products, with already 13 drugs approved in the European Union and United States as well three biosimilar versions etanercept. products combine tailored pharmacological properties biological ligands, together multiple functions fragment crystallizable domain immunoglobulins. There is great diversity terms possible including extracellular domains natural receptors, functionally active peptides, recombinant enzymes, genetically engineered binding constructs acting cytokine traps. Due to their highly diverse structures, analytical characterization far more complex than that monoclonal antibodies requires use development additional product-specific methods over conventional generic/platform methods. This can be explained, for example, by presence numerous sialic acids, leading high isoelectric points glycosylation profiles N- O-linked sites. In this review, we highlight wide range strategies used fully characterize Fc-fusion proteins. We also present case studies on structural assessment all commercially available proteins, based features critical quality attributes ligand-binding domains.

Language: Английский

Citations

114

Soluble ligands as drug targets DOI Open Access
Misty M. Attwood, Jörgen Jönsson, Mathias Rask‐Andersen

et al.

Nature Reviews Drug Discovery, Journal Year: 2020, Volume and Issue: 19(10), P. 695 - 710

Published: Sept. 1, 2020

Language: Английский

Citations

95

Shift From Adalimumab Originator to Biosimilars in Denmark DOI Open Access
Thomas Bo Jensen, Seoyoung C. Kim, Espen Jimenez‐Solem

et al.

JAMA Internal Medicine, Journal Year: 2020, Volume and Issue: 180(6), P. 902 - 902

Published: March 30, 2020

Decreasing Health Care Spending Through Market Competition—a Case for the Rapid Adoption of Adalimumab Biosimilars

Language: Английский

Citations

72

Chiral Separations in Preparative Scale: A Medicinal Chemistry Point of View DOI Creative Commons
Madalena Pinto, Carla Fernandes, Maria Elizabeth Tiritan

et al.

Molecules, Journal Year: 2020, Volume and Issue: 25(8), P. 1931 - 1931

Published: April 21, 2020

Enantiomeric separation is a key step in the development of new chiral drug. Preparative liquid chromatography (LC) continues to be technique choice either during drug discovery process, achieve few milligrams, or scale-up clinical trial, needing kilograms material. However, last years, instrumental and technical developments allowed an exponential increase preparative enantioseparation using other techniques. Besides LC, supercritical fluid (SFC) counter-current (CCC) have aroused interest for separation. This overview will highlight importance separations Medicinal Chemistry, especially early stages pipeline drugs development. Few examples within different methodologies selected, emphasizing trends The advantages drawbacks critically discussed.

Language: Английский

Citations

72

In-depth analysis of monoclonal antibodies using microfluidic capillary electrophoresis and native mass spectrometry DOI
Sara Carillo, Craig Jakes, Jonathan Bones

et al.

Journal of Pharmaceutical and Biomedical Analysis, Journal Year: 2020, Volume and Issue: 185, P. 113218 - 113218

Published: Feb. 29, 2020

Language: Английский

Citations

57

Approaches and materials for endocytosis-independent intracellular delivery of proteins DOI Open Access
Nanxi Chen, Ye He,

Mingming Zang

et al.

Biomaterials, Journal Year: 2022, Volume and Issue: 286, P. 121567 - 121567

Published: May 7, 2022

Language: Английский

Citations

35

Spending, Utilization, and Price Trends for Immune Checkpoint Inhibitors in US Medicaid Programs: An Empirical Analysis from 2011 to 2021 DOI Open Access
Young Eun Shin, Arun Kumar, Jeff J. Guo

et al.

Clinical Drug Investigation, Journal Year: 2023, Volume and Issue: 43(4), P. 289 - 298

Published: April 1, 2023

Language: Английский

Citations

17