Pharmaceutical development of AAV-based gene therapy products for the eye

GA Rodrigues, E Shalaev, TK Karami… - Pharmaceutical …, 2019 - Springer
A resurgence of interest and investment in the field of gene therapy, driven in large part by
advances in viral vector technology, has recently culminated in United States Food and Drug …

The freezing step in lyophilization: Physico-chemical fundamentals, freezing methods and consequences on process performance and quality attributes of …

JC Kasper, W Friess - European journal of pharmaceutics and …, 2011 - Elsevier
Lyophilization is a common, but cost-intensive, drying process to achieve protein
formulations with long-term stability. In the past, typical process optimization has focused on …

The importance of understanding the freezing step and its impact on freeze-drying process performance

G Assegehegn, E Brito-de la Fuente, JM Franco… - Journal of …, 2019 - Elsevier
The freeze-drying process is a combination of 2 equally important processes, freezing, and
drying. In the past, the effort was mainly focused on optimizing the drying process without …

Instability of therapeutic proteins—An overview of stresses, stabilization mechanisms and analytical techniques involved in Lyophilized proteins

A Butreddy, KY Janga, S Ajjarapu, S Sarabu… - International journal of …, 2021 - Elsevier
Solid-state is the preferred choice for storage of protein therapeutics to improve stability and
preserve the biological activity by decreasing the physical and chemical degradation …

Facts and evidences on the lyophilization of polymeric nanoparticles for drug delivery

P Fonte, S Reis, B Sarmento - Journal of controlled release, 2016 - Elsevier
Lyophilization has been used to improve the long-term stability of polymeric nanoparticles
for drug delivery applications, avoiding their instability in suspension. However, this …

[图书][B] Surimi and surimi seafood

JW Park - 2005 - taylorfrancis.com
Written by internationally recognized experts, Surimi and Surimi Seafood, Second Edition
provides a wealth of up-to-the-minute information on all aspects of the production of surimi …

Stability of lyophilized and spray dried vaccine formulations

KB Preston, TW Randolph - Advanced Drug Delivery Reviews, 2021 - Elsevier
Liquid formulations of vaccines are subject to instabilities that result from degradation
processes that proceed via a variety of physical and chemical pathways. In dried …

Interfacial stress in the development of biologics: fundamental understanding, current practice, and future perspective

J Li, ME Krause, X Chen, Y Cheng, W Dai, JJ Hill… - The AAPS journal, 2019 - Springer
Biologic products encounter various types of interfacial stress during development,
manufacturing, and clinical administration. When proteins come in contact with vapor–liquid …

Recent advances and further challenges in lyophilization

JC Kasper, G Winter, W Friess - European Journal of Pharmaceutics and …, 2013 - Elsevier
While entering a new century, lyophilization in the pharmaceutical field has been subjected
to ongoing development and steady expansion. This review aims to highlight recent …

Current perspectives on stability of protein drug products during formulation, fill and finish operations

N Rathore, RS Rajan - Biotechnology progress, 2008 - Wiley Online Library
Commercialization of protein‐based therapeutics is a challenging task in part due to the
difficulties in maintaining protein solutions safe and efficacious throughout the drug product …