High concentration formulation developability approaches and considerations

J Zarzar, T Khan, M Bhagawati, B Weiche… - MAbs, 2023 - Taylor & Francis
The growing need for biologics to be administered subcutaneously and ocularly, coupled
with certain indications requiring high doses, has resulted in an increase in drug substance …

Monoclonal antibody and protein therapeutic formulations for subcutaneous delivery: high-concentration, low-volume vs. low-concentration, high-volume

M Desai, A Kundu, M Hageman, H Lou, D Boisvert - MAbs, 2023 - Taylor & Francis
Biologic drugs are used to treat a variety of cancers and chronic diseases. While most of
these treatments are administered intravenously by trained healthcare professionals, a …

Terminal supraparticle assemblies from similarly charged protein molecules and nanoparticles

JI Park, TD Nguyen, G de Queirós Silveira… - Nature …, 2014 - nature.com
Self-assembly of proteins and inorganic nanoparticles into terminal assemblies makes
possible a large family of uniformly sized hybrid colloids. These particles can be compared …

Frozen-state storage stability of a monoclonal antibody: aggregation is impacted by freezing rate and solute distribution

MA Miller, MA Rodrigues, MA Glass, SK Singh… - Journal of …, 2013 - Elsevier
Freezing of protein solutions perturbs protein conformation, potentially leading to aggregate
formation during long-term storage in the frozen state. Macroscopic protein concentration …

A cocktail of humanized anti–pertussis toxin antibodies limits disease in murine and baboon models of whooping cough

AW Nguyen, EK Wagner, JR Laber… - Science translational …, 2015 - science.org
Despite widespread vaccination, pertussis rates are rising in industrialized countries and
remain high worldwide. With no specific therapeutics to treat disease, pertussis continues to …

A novel approach for real-time enumeration of Escherichia coli ATCC 47076 in water through high multi-functional engineered nano-dispersible electrode

S Panhwar, A Aftab, HA Keerio… - Journal of The …, 2021 - iopscience.iop.org
The climate change is significantly evolving novel microbes in the environment. In addition,
nanoscience is advancing promptly to provide environmentally friendly engineering …

Viscosity reduction of a concentrated monoclonal antibody with arginine· HCl and arginine· glutamate

AU Borwankar, BJ Dear, A Twu, JJ Hung… - Industrial & …, 2016 - ACS Publications
To further advance a subcutaneous injection of monoclonal antibodies (mAbs) at elevated
concentrations, novel concepts are needed to lower the viscosity. The addition of high …

[HTML][HTML] Biopharmaceutical nanoclusters: Towards the self-delivery of protein and peptide therapeutics

M Danielsen, C Hempel, TL Andresen… - Journal of Controlled …, 2022 - Elsevier
Protein and peptide biopharmaceuticals have had a major impact on the treatment of a
number of diseases. There is a growing interest in overcoming some of the challenges …

Dual Responsive Disposable Electrode for the Enumeration of Escherichia coli in Whole Blood

S Panhwar, H Ilhan, SS Hassan, A Zengin… - …, 2020 - Wiley Online Library
In this report, we have designed a dual responsive disposable electrode for the enumeration
of Escherichia coli K12 (E. coli K12). The immunomagnetic separation strategy provided …

High-throughput analysis of sub-visible mAb aggregate particles using automated fluorescence microscopy imaging

AJ Paul, F Bickel, M Röhm, L Hospach… - Analytical and …, 2017 - Springer
Aggregation of therapeutic proteins is a major concern as aggregates lower the yield and
can impact the efficacy of the drug as well as the patient's safety. It can occur in all …