Virus filtration: A review of current and future practices in bioprocessing
For drug products manufactured in mammalian cells, safety assurance practices are needed
during production to assure that the final medicinal product is safe from the potential risk of …
during production to assure that the final medicinal product is safe from the potential risk of …
Adapting viral safety assurance strategies to continuous processing of biological products
SA Johnson, MR Brown, SC Lute… - Biotechnology and …, 2017 - Wiley Online Library
There has been a recent drive in commercial large‐scale production of biotechnology
products to convert current batch mode processing to continuous processing manufacturing …
products to convert current batch mode processing to continuous processing manufacturing …
Nanofiltration as a robust method contributing to viral safety of plasma‐derived therapeutics: 20 yearsʼ experience of the plasma protein manufacturers
NJ Roth, HO Dichtelmüller, F Fabbrizzi, E Flechsig… - …, 2020 - Wiley Online Library
Background Nanofiltration entails the filtering of protein solutions through membranes with
pores of nanometric sizes that have the capability to effectively retain a wide range of …
pores of nanometric sizes that have the capability to effectively retain a wide range of …
Effect of operating pressure on protein fouling during constant-pressure virus removal filtration
Virus removal filtration provides a robust size-based removal of enveloped and non-
enveloped viruses in the production of monoclonal antibodies and serum-derived products …
enveloped viruses in the production of monoclonal antibodies and serum-derived products …
First update of the International Xenotransplantation Association consensus statement on conditions for undertaking clinical trials of porcine islet products in type 1 …
T Spizzo, J Denner, L Gazda, M Martin… - …, 2016 - Wiley Online Library
Chapter 2 of the original consensus statement published in 2009 by IXA represents an
excellent basis for the production of safe donor pigs and pig‐derived materials for porcine …
excellent basis for the production of safe donor pigs and pig‐derived materials for porcine …
The step-wise framework to design a chromatography-based hydrophobicity assay for viral particles
SA Johnson, A Walsh, MR Brown, SC Lute… - … of Chromatography B, 2017 - Elsevier
A high-salt, hydrophobic interaction chromatography (HIC) method was developed to
measure the relative hydrophobicity of a diverse set of solutes. Through the careful control of …
measure the relative hydrophobicity of a diverse set of solutes. Through the careful control of …
Impact of proteins and protein fouling on virus retention during virus removal filtration
Virus filtration is a crucial step in ensuring the high levels of viral clearance required in the
production of biotherapeutics produced in mammalian cells or derived from human plasma …
production of biotherapeutics produced in mammalian cells or derived from human plasma …
[HTML][HTML] Transfusion-Transmitted Disorders 2023 with Special Attention to Bone Marrow Transplant Patients
M Udvardy, Á Illés, L Gergely, LI Pinczés, F Magyari… - Pathogens, 2023 - mdpi.com
Transfusion medicine is traditionally a strong/fundamental part of clinical practice, saving
hundreds of millions of lives. However, blood-borne or transmitted infections are a well …
hundreds of millions of lives. However, blood-borne or transmitted infections are a well …
Application of formulation principles to stability issues encountered during processing, manufacturing, and storage of drug substance and drug product protein …
S Vitharana, JM Stillahn, DS Katayama… - Journal of …, 2023 - Elsevier
The field of formulation and stabilization of protein therapeutics has become rather
extensive. However, most of the focus has been on stabilization of the final drug product …
extensive. However, most of the focus has been on stabilization of the final drug product …
Primary cell culture from the nose of a marine organism, the banded houndshark, Triakis scyllium
SM Jung, DS Kim, HS Shin - Biotechnology and bioprocess engineering, 2013 - Springer
Animal cells have been widely and continuously studied due to their usefulness in biological
researches and production of pharmacological agents as well as food additives …
researches and production of pharmacological agents as well as food additives …