[HTML][HTML] Viral contamination in biologic manufacture and implications for emerging therapies

PW Barone, ME Wiebe, JC Leung, ITM Hussein… - Nature …, 2020 - nature.com
Recombinant protein therapeutics, vaccines, and plasma products have a long record of
safety. However, the use of cell culture to produce recombinant proteins is still susceptible to …

Extracellular vesicles as nanomedicine: hopes and hurdles in clinical translation

T Burnouf, V Agrahari, V Agrahari - International journal of …, 2019 - Taylor & Francis
The clinical development of cell therapies is revealing that extracellular vesicles (EVs) may
become very instrumental as subcellular therapeutic adjuncts in human medicine. EVs are …

Scale‐up economics for cultured meat

D Humbird - Biotechnology and Bioengineering, 2021 - Wiley Online Library
This analysis examines the potential of “cultured meat” products made from edible animal
cell culture to measurably displace the global consumption of conventional meat …

Removal of xenotropic murine leukemia virus by nanocellulose based filter paper

M Asper, T Hanrieder, A Quellmalz, A Mihranyan - Biologicals, 2015 - Elsevier
The removal of xenotrpic murine leukemia virus (xMuLV) by size-exclusion filter paper
composed of 100% naturally derived cellulose was validated. The filter paper was produced …

A different perspective: how much innovation is really needed for monoclonal antibody production using mammalian cell technology?

B Kelley, R Kiss, M Laird - New Bioprocessing Strategies: Development …, 2018 - Springer
As biopharmaceutical companies have optimized cell line and production culture process
development, titers of recombinant antibodies have risen steadily to 3–8 g/L for fed-batch …

Mille-feuille paper: A novel type of filter architecture for advanced virus separation applications

S Gustafsson, P Lordat, T Hanrieder, M Asper… - Materials …, 2016 - pubs.rsc.org
Mille-feuille (“a thousand leaves”) paper is the first non-woven, wet-laid filter paper,
composed of 100% native cellulose, which is capable of removal of the “worst-case” model …

[HTML][HTML] Prospects on the use of Schizochytrium sp. to develop oral vaccines

A Ramos-Vega, S Rosales-Mendoza… - Frontiers in …, 2018 - frontiersin.org
Although oral subunit vaccines are highly relevant in the fight against widespread diseases,
their high cost, safety and proper immunogenicity are attributes that have yet to be …

[HTML][HTML] Mechanistic insights into flow-dependent virus retention in different nanofilter membranes

R Leisi, E Widmer, B Gooch, NJ Roth, C Ros - Journal of Membrane …, 2021 - Elsevier
Virus filtration is a downstream unit operation in the manufacturing of biotherapeutics to
remove potential viral contaminations based on size exclusion. While even very small …

[HTML][HTML] CRISPR/Cas9 gene editing for the creation of an MGAT1-deficient CHO cell line to control HIV-1 vaccine glycosylation

G Byrne, SM O'Rourke, DL Alexander, B Yu… - PLoS …, 2018 - journals.plos.org
Over the last decade, multiple broadly neutralizing monoclonal antibodies (bN-mAbs) to the
HIV-1 envelope protein (Env) gp120 have been described. Many of these recognize …

Use of MMV as a single worst-case model virus in viral filter validation studies

E Gefroh, H Dehghani, M McClure… - PDA journal of …, 2014 - journal.pda.org
Typical platform processes for biopharmaceutical products derived from animal cell lines
include a parvovirus filtration unit operation to provide viral safety assurance of the drug …