[PDF][PDF] Risk assessment approach to microbiological controls of cell therapies

T Cundell, S Drummond, I Ford, D Reber… - PDA Journal of …, 2020 - researchgate.net
This technology review, written by a small group of pharmaceutical microbiologists
experienced in cell therapies, discussed a risk-based approach to microbiological …

Practicing safe cell culture: applied process designs for minimizing virus contamination risk

RD Kiss - PDA Journal of Pharmaceutical Science and …, 2011 - journal.pda.org
CONFERENCE PROCEEDING Proceedings of the PDA/FDA Adventitious Viruses in
Biologics: Detection and Mitigation Strategies Workshop in Bethesda, MD, USA; December …

Regulatory and microbiological safety issues surrounding cell and tissue‐engineering products

DN Galbraith - Biotechnology and applied biochemistry, 2004 - Wiley Online Library
Cell therapies and tissue‐engineered products that contain living cells are potentially some
of the most exciting of the novel therapeutic products currently under development. These …

Microbiological risk assessment in stem cell manipulation

A Pessina, A Bonomi, C Baglio… - Critical reviews in …, 2008 - Taylor & Francis
Cell therapy based on the use of human stem cells is more complicated than transfusion or
organ transplantation because cells may undergo many additional manipulations due to …

Bacterial safety of cell‐based therapeutic preparations, focusing on haematopoietic progenitor cells

M Störmer, EM Wood, U Schurig, O Karo… - Vox …, 2014 - Wiley Online Library
Bacterial safety of cellular preparations, especially haematopoietic progenitor cells (HPC s),
as well as advanced therapy medicinal products (ATMP s) derived from stem cells of various …

Cell culture contamination: sources, consequences, prevention, and elimination

CK Lincoln, MG Gabridge - Methods in cell biology, 1998 - Elsevier
Publisher Summary Contamination may enter a cell-culture system as a physical, chemical,
and/or biological component of the environment. The potential sources and consequences …

Bringing safe and effective cell therapies to the bedside

RA Preti - Nature biotechnology, 2005 - nature.com
Bringing safe and effective cell therapies to the bedside | Nature Biotechnology Skip to main
content Thank you for visiting nature.com. You are using a browser version with limited support …

Part 3: Understanding the manufacturing of unproven cellular therapy products

P Eldridge, D Griffin, W Janssen, L O'Donnell - Cytotherapy, 2016 - Elsevier
As stated in the other parts of this guide, the delivery of cells to patients requires transparent,
rigorous manufacturing steps that are clearly defined and well understood. What raises a …

[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 …

Transitioning from development to commercial: risk-based guidance for critical materials management in cell therapies

M Scott, D Clarke, Y Lipsitz, H Brandwein, J Allickson… - Cytotherapy, 2020 - Elsevier
A key hurdle to ensuring patient access to cell and gene therapies (CGTs) and continued
growth of the industry is the management of raw materials. The combination of rapid growth …