[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 …
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 …
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 …
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 …
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 …
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 …
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 …
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 …
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 …
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 …
employ lyophilization (freeze drying) process to create dry glassy state dosage form. The …