Surface-induced protein aggregation and particle formation in biologics: current understanding of mechanisms, detection and mitigation strategies

MRG Kopp, F Grigolato, D Zürcher, TK Das… - Journal of …, 2023 - Elsevier
Protein stability against aggregation is a major quality concern for the production of safe and
effective biopharmaceuticals. Amongst the different drivers of protein aggregation …

[HTML][HTML] A framework for the biophysical screening of antibody mutations targeting solvent-accessible hydrophobic and electrostatic patches for enhanced viscosity …

GB Armstrong, V Shah, P Sanches, M Patel… - Computational and …, 2024 - Elsevier
The formulation of high-concentration monoclonal antibody (mAb) solutions in low dose
volumes for autoinjector devices poses challenges in manufacturability and patient …

Variable domain mutational analysis to probe the molecular mechanisms of high viscosity of an IgG1 antibody

J Dai, S Izadi, J Zarzar, P Wu, A Oh, PJ Carter - MAbs, 2024 - Taylor & Francis
Subcutaneous injection is the preferred route of administration for many antibody
therapeutics for reasons that include its speed and convenience. However, the small volume …

A comparative study of the developability of full-length antibodies, fragments, and bispecific formats reveals higher stability risks for engineered constructs

I Condado-Morales, F Dingfelder, I Waibel… - MAbs, 2024 - Taylor & Francis
Engineered antibody formats, such as antibody fragments and bispecifics, have the potential
to offer improved therapeutic efficacy compared to traditional full-length monoclonal …

A first insight into the developability of an immunoglobulin G3: a combined computational and experimental approach

GB Armstrong, A Lewis, V Shah, P Taylor… - ACS Pharmacology & …, 2024 - ACS Publications
Immunoglobulin G 3 (IgG3) monoclonal antibodies (mAbs) are high-value scaffolds for
develo** novel therapies. Despite their wide-ranging therapeutic potential, IgG3 …

Biomolecular condensates sustain pH gradients at equilibrium driven by charge neutralisation

H Ausserwöger, R Scrutton, T Sneideris, CM Fischer… - BioRxiv, 2024 - biorxiv.org
Electrochemical gradients are essential to the functioning of cells and are typically formed
across membranes using active transporters and require energy input to maintain them …

Development of Zalfermin, a Long-Acting Proteolytically Stabilized FGF21 Analog

K Sass-Ørum, TM Tagmose, J Olsen… - Journal of Medicinal …, 2024 - ACS Publications
Here, we describe the development of the FGF21 analog zalfermin (NNC0194-0499, 15),
intended for once-weekly sc dosing. Protein engineering was needed to address inherent …

Nonspecificity fingerprints for clinical-stage antibodies in solution

TW Herling, G Invernizzi… - Proceedings of the …, 2023 - National Acad Sciences
Monoclonal antibodies (mAbs) have successfully been developed for the treatment of a wide
range of diseases. The clinical success of mAbs does not solely rely on optimal potency and …

AF4 and PEG Precipitation as Predictive Assays for Antibody Self-Association

I Condado-Morales, V Sokolova… - Molecular …, 2023 - ACS Publications
Monoclonal antibodies (mAbs) are often formulated as high-protein-concentration solutions,
which in some cases can exhibit physical stability issues such as high viscosity and …

A first insight into the developability of an IgG3: A combined computational and experimental approach

GB Armstrong, A Lewis, V Shah, P Taylor, CJ Jamieson… - bioRxiv, 2024 - biorxiv.org
ABSTRACT Immunoglobulin G 3 (IgG3) monoclonal antibodies (mAbs) are high value
scaffolds for develo** novel therapies. Despite their wide-ranging therapeutic potential …