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US FDA-approved therapeutic antibodies with high-concentration formulation: summaries and perspectives
SS Wang, Y Yan, K Ho - Antibody therapeutics, 2021 - academic.oup.com
Thirty four (34) of the total US FDA approved 103 therapeutic antibody drugs, accounts for
one third of the total approved mAbs, are formulated with high protein concentration (100 …
one third of the total approved mAbs, are formulated with high protein concentration (100 …
Blueprint for antibody biologics developability
C Mieczkowski, X Zhang, D Lee, K Nguyen, W Lv… - MAbs, 2023 - Taylor & Francis
Large-molecule antibody biologics have revolutionized medicine owing to their superior
target specificity, pharmacokinetic and pharmacodynamic properties, safety and toxicity …
target specificity, pharmacokinetic and pharmacodynamic properties, safety and toxicity …
Cell-laden nanocellulose/chitosan-based bioinks for 3D bioprinting and enhanced osteogenic cell differentiation
3D bioprinting has recently emerged as a very useful tool in tissue engineering and
regenerative medicine. However, develo** suitable bioinks to fabricate specific tissue …
regenerative medicine. However, develo** suitable bioinks to fabricate specific tissue …
[HTML][HTML] Ongoing challenges to develop high concentration monoclonal antibody-based formulations for subcutaneous administration: quo vadis?
W Jiskoot, A Hawe, T Menzen, DB Volkin… - Journal of …, 2022 - Elsevier
Although many subcutaneously (sc) delivered, high-concentration antibody formulations
(HCAF) have received regulatory approval and are widely used commercially, formulation …
(HCAF) have received regulatory approval and are widely used commercially, formulation …
Structure, heterogeneity and developability assessment of therapeutic antibodies
Y Xu, D Wang, B Mason, T Rossomando, N Li, D Liu… - MAbs, 2019 - Taylor & Francis
Increasing attention has been paid to developability assessment with the understanding that
thorough evaluation of monoclonal antibody lead candidates at an early stage can avoid …
thorough evaluation of monoclonal antibody lead candidates at an early stage can avoid …
One‐step photoactivation of a dual‐functionalized bioink as cell carrier and cartilage‐binding glue for chondral regeneration
Cartilage defects can result in pain, disability, and osteoarthritis. Hydrogels providing a
chondroregeneration‐permissive environment are often mechanically weak and display …
chondroregeneration‐permissive environment are often mechanically weak and display …
Science and art of protein formulation development
W Wang, S Ohtake - International journal of pharmaceutics, 2019 - Elsevier
Protein pharmaceuticals have become a significant class of marketed drug products and are
expected to grow steadily over the next decade. Development of a commercial protein …
expected to grow steadily over the next decade. Development of a commercial protein …
The texture of plant protein‐based meat analogs by high moisture extrusion: A review
X Zhang, Y Zhao, X Zhao, P Sun, D Zhao… - Journal of texture …, 2023 - Wiley Online Library
Meat analogs produced by high moisture extrusion (HME) are considered to be one of the
products that have great potential for replacing real meat. The key issue as a meat analog is …
products that have great potential for replacing real meat. The key issue as a meat analog is …
The evolution of commercial antibody formulations
CA Mieczkowski - Journal of Pharmaceutical Sciences, 2023 - Elsevier
It has been nearly four decades since the first therapeutic monoclonal antibodies were
approved and made available for widespread human use. Herein, US and EU approved …
approved and made available for widespread human use. Herein, US and EU approved …
Quantifying protein shape to elucidate its influence on solution viscosity in high-concentration electrolyte solutions
Therapeutic proteins with a high concentration and low viscosity are highly desirable for
subcutaneous and certain local injections. The shape of a protein is known to influence …
subcutaneous and certain local injections. The shape of a protein is known to influence …