Intraocular delivery considerations of ocular biologic products and key preclinical determinations

P Hughes, HM Rivers, V Bantseev… - Expert Opinion on …, 2023 - Taylor & Francis
Introduction Ophthalmic diseases of the retina are a significant cause of vision loss globally.
Despite much progress, there remains an unmet need for durable, long-acting treatment …

In vitro models for immunogenicity prediction of therapeutic proteins

F Groell, O Jordan, G Borchard - European Journal of Pharmaceutics and …, 2018 - Elsevier
Immunogenicity assessment of therapeutic proteins is routinely performed through various
techniques during the drug development process:(i) in silico to design the least …

Analysis of proteins, protein complexes, and organellar proteomes using sheathless capillary zone electrophoresis-native mass spectrometry

AM Belov, R Viner, MR Santos, DM Horn… - Journal of The …, 2017 - ACS Publications
Native mass spectrometry (MS) is a rapidly advancing field in the analysis of proteins,
protein complexes, and macromolecular species of various types. The majority of native MS …

Nonclinical immunogenicity risk assessment of therapeutic proteins

S Tourdot, TP Hickling - Bioanalysis, 2019 - Taylor & Francis
Therapeutic protein drugs have significantly improved the management of many severe and
chronic diseases. However, their development and optimal clinical application are …

[HTML][HTML] Insulin amyloid morphology is encoded in H-bonds and electrostatics interactions ruling protein phase separation

S Lenton, H Chaaban, M Khaled… - Journal of colloid and …, 2025 - Elsevier
Ion-protein interactions regulate biological processes and are the basis of key strategies of
modulating protein phase diagrams and stability in drug development. Here, we report the …

Modeling approaches for reducing safety-related attrition in drug discovery and development: a review on myelotoxicity, immunotoxicity, cardiovascular toxicity, and …

EM Tosca, R Bartolucci, P Magni… - Expert Opinion on Drug …, 2021 - Taylor & Francis
Introduction: Safety and tolerability is a critical area where improvements are needed to
decrease the attrition rates during development of new drug candidates. Modeling …

Importance of feedback and feedforward loops to adaptive immune response modeling

A Rahman, A Tiwari, J Narula… - CPT: Pharmacometrics …, 2018 - Wiley Online Library
The human adaptive immune system is a very complex network of different types of cells,
cytokines, and signaling molecules. This complex network makes it difficult to understand …

Immunogenicity of therapeutic biological modalities-lessons from hemophilia A therapies

NH Nguyen, NL Jarvi, SV Balu-Iyer - Journal of Pharmaceutical Sciences, 2023 - Elsevier
The introduction and development of biologics such as therapeutic proteins, gene-, and cell-
based therapy have revolutionized the scope of treatment for many diseases. However, a …

Revisit PEG-Induced precipitation assay for protein solubility assessment of monoclonal antibody formulations

MJ Scannell, MW Hyatt, IL Budyak, MA Woldeyes… - Pharmaceutical …, 2021 - Springer
Purpose Protein solubility is an important attribute of pharmaceutical monoclonal antibody
(MAb) formulations, particularly at high MAb concentrations. PEG-induced protein …

Poly (ethylene) glycol (PEG) precipitation of glycosylated and non-glycosylated monoclonal antibodies

K Li, O Bermudez, D Forciniti - Process Biochemistry, 2022 - Elsevier
The solubility of monoclonal antibodies (mAb) affects their production and their intravenous
administration to patients. In this work, the solubility of a fully glycosylated and a non …