[HTML][HTML] Stabilizing vaccines via drying: Quality by design considerations

Z Ghaemmaghamian, R Zarghami, G Walker… - Advanced Drug Delivery …, 2022 - Elsevier
Pandemics and epidemics are continually challenging human beings' health and imposing
major stresses on the societies particularly over the last few decades, when their frequency …

[HTML][HTML] Prefilled dual chamber devices (DCDs)–promising high-quality and convenient drug delivery system

RG Ingle, WJ Fang - International Journal of Pharmaceutics, 2021 - Elsevier
Prefilled dual chamber devices (DCDs) are combination products containing freeze-dried
drug and diluent in two separate chambers of the device. DCDs provide high stability and …

Toward a point-of-need bioluminescence-based immunoassay utilizing a complete shelf-stable reagent

MP Hall, VA Kincaid, EA Jost, TP Smith… - Analytical …, 2021 - ACS Publications
Enzyme-linked immunosorbent assays (ELISAs) are used extensively for the detection and
quantification of biomolecules in clinical diagnostics as well as in basic research. Although …

Mechanisms by which crystalline mannitol improves the reconstitution time of high concentration lyophilized protein formulations

SS Kulkarni, R Suryanarayanan, JV Rinella Jr… - European journal of …, 2018 - Elsevier
Lyophilized high concentration protein formulations often have long and variable
reconstitution times. The aim is to understand the role of crystalline mannitol in lowering the …

Crystallizing amino acids as bulking agents in freeze-drying

J Horn, E Tolardo, D Fissore, W Friess - European Journal of Pharmaceutics …, 2018 - Elsevier
Bulking agents as mannitol (Man) and glycine (Gly) require high bulking agent to stabilizer
ratios to ensure their crystallization during the freeze-drying process. The aim of this study …

Key factors governing the reconstitution time of high concentration lyophilized protein formulations

SS Kulkarni, SM Patel, R Suryanarayanan… - European Journal of …, 2021 - Elsevier
Lyophilized protein formulations containing highly concentrated proteins often have long
and variable reconstitution times. Reconstitution time is dependent on a number of factors in …

Opportunities in an evolving pharmaceutical development landscape: product differentiation of biopharmaceutical drug products

A Allmendinger - Pharmaceutical Research, 2021 - Springer
The current perspective reviews the biopharmaceutical market until end of 2020 and
highlights the transforming biopharmaceutical landscape during the recent decade. In …

[PDF][PDF] Multiple approaches to reduce reconstitution time of lyophilized drug products with high protein concentration

X Zhang, N Zhou, C Yang, Z Jin, J Guo - Antibody Therapeutics, 2024 - academic.oup.com
Background Lyophilized drug products with high protein concentration often perform long
reconstitution time, which is inconvenient for clinical use. The objective of this work is to …

Formulation Design for Freeze-Drying: Case Studies of Stabilization of Proteins

A Allmendinger, C Häuser, L Kumar… - Principles and Practices of …, 2023 - Springer
Abstract Formulation design is an integral part of drug product development for parenterally
applied dosage forms. In particular for freeze-dried formulations, the choice of excipients is …

Concepts and Strategies in the Design of Formulations for Freeze Drying

F Jameel - Principles and Practices of Lyophilization in Product …, 2023 - Springer
In order to enhance the storage stability of water labile molecules the common practice is to
employ lyophilization (freeze drying) process to create dry glassy state dosage form. The …