Chemometrics in Protein Formulation: Stability Governed by Repulsion and Protein Unfolding

A Kulakova, D Augustijn, I El Bialy… - Molecular …, 2023 - ACS Publications
Therapeutic proteins can be challenging to develop due to their complexity and the
requirement of an acceptable formulation to ensure patient safety and efficacy. To date …

Advancing therapeutic protein discovery and development through comprehensive computational and biophysical characterization

L Gentiluomo, HL Svilenov, D Augustijn… - Molecular …, 2019 - ACS Publications
Therapeutic protein candidates should exhibit favorable properties that render them suitable
to become drugs. Nevertheless, there are no well-established guidelines for the efficient …

[HTML][HTML] Advances in biophysical and bioanalytical protein characterization

JS Laurence - Molecular Pharmaceutics, 2012 - ACS Publications
Over the past few years, emphasis in drug development has shifted substantially from small
organic compounds toward macromolecules, particularly monoclonal antibodies (mAbs), to …

High-throughput biophysical analysis of protein therapeutics to examine interrelationships between aggregate formation and conformational stability

R Chaudhuri, Y Cheng, CR Middaugh, DB Volkin - The AAPS journal, 2014 - Springer
Stabilization and formulation of therapeutic proteins against physical instability, both
structural alterations and aggregation, is particularly challenging not only due to each …

Application of a high-throughput relative chemical stability assay to screen therapeutic protein formulations by assessment of conformational stability and correlation to …

JM Rizzo, S Shi, Y Li, A Semple, JJ Esposito… - Journal of …, 2015 - Elsevier
In this study, an automated high-throughput relative chemical stability (RCS) assay was
developed in which various therapeutic proteins were assessed to determine stability based …

Simplified choice of suitable excipients within biologics formulation design using protein-protein interaction-and water activity-maps

T Stolzke, C Brandenbusch - European Journal of Pharmaceutics and …, 2022 - Elsevier
Still today, high-concentration protein formulations are often developed based on high-
throughput experimental screening approaches. Although likely delivering working …

Enabling efficient design of biological formulations through advanced characterizations

K Chen, JK Cheung, HY Kim, A Leone, K Mallela… - Pharmaceutical …, 2023 - Springer
Biologics continue to play an increasingly dominant role in the modern pharmaceutical
market. The primary objective of formulation development is to efficiently deliver a …

Rapid methodology for basal system selection of therapeutic proteins during the early stage biopharmaceutical development

NA Kim, B Heo, SH Jeong - Journal of Pharmaceutical Investigation, 2020 - Springer
Purpose This study aimed to introduce a quick method for developing formulations during
the early stages of biopharmaceutical drug development, starting from the isoelectric point (p …

Innovative Pharmaceutical Stabilization and Formulation Processes for Protein Drugs and Their Impact on Sequence and Structure. Part: Analytics

YY Elsayed, T Kühl, D Imhof - Dispersity, Structure and Phase Changes of …, 2024 - Springer
Peptide and protein design for biopharmaceutical and food applications gained
considerable attention in recent years. Numerous peptides and proteins are approved every …

Development, characterization and stability of therapeutic protein co-formulations

D Krieg - 2021 - edoc.ub.uni-muenchen.de
Protein therapeutics have steadily gained importance for the targeted pharmacotherapy of
severe diseases in the last decades. The specific targeting of a single antigen has proven to …