Comprehensive study identifies a sensitive, low-risk, closed-system model for detection of fungal contaminants in cell and gene therapy products
NE Putnam, AF Lau - Journal of Clinical Microbiology, 2021 - Am Soc Microbiol
ABSTRACT The US Food and Drug Administration (FDA) regulates manufacturing and
testing of advanced therapeutic medicinal products (ATMPs) to ensure the safety of each …
testing of advanced therapeutic medicinal products (ATMPs) to ensure the safety of each …
Differentiation of human pluripotent stem cells into insulin-producing islet-like clusters using nanofiltered cell culture medium
J Thorngren, S Vasylovska, J Blanc, L Wu… - Frontiers in Membrane …, 2024 - frontiersin.org
The challenge of using patient-specific, autologous stem cell therapies in clinical settings is
the need for advanced cell processing and expansion technologies. These include …
the need for advanced cell processing and expansion technologies. These include …
Contamination Control Strategy: Implementation Road Map
W El Azab - PDA Journal of Pharmaceutical Science and …, 2021 - journal.pda.org
The article proposes an implementation road map of a contamination control strategy (CCS)
in a facility. The CCS is the culmination of an exercise to identify activities designed to …
in a facility. The CCS is the culmination of an exercise to identify activities designed to …
[HTML][HTML] Report of a clinical and laboratory management of cell therapy for knee cartilage in the face of mycoplasma contamination
To describe a case of autologous chondrocyte implantation after cell culture contamination
by Mycoplasma pneumoniae and the measures taken to successfully complete cell therapy …
by Mycoplasma pneumoniae and the measures taken to successfully complete cell therapy …
Adventitious Agent Contamination Considerations during the Manufacture of Cell and Gene Therapy Products
H Aranha - Handbook of Cell and Gene Therapy, 2023 - taylorfrancis.com
Contamination control in cell and gene (CGT) therapy manufacturing must, of necessity, use
a pragmatic strategy compared with traditional biopharmaceuticals. Living cells are both the …
a pragmatic strategy compared with traditional biopharmaceuticals. Living cells are both the …
Report of a clinical and laboratory management of cell therapy for knee cartilage in the face of mycoplasma contamination.
A Rozim Zorzi, E Antonioli… - Einstein …, 2022 - search.ebscohost.com
To describe a case of autologous chondrocyte implantation after cell culture contamination
by Mycoplasma pneumoniae and the measures taken to successfully complete cell therapy …
by Mycoplasma pneumoniae and the measures taken to successfully complete cell therapy …
[PDF][PDF] Treatment of Osteoarthritis with Autologous and Allogeneic Expanded Bone Marrow Mesenchymal Stem Cells
P Hollands, D Porter - cellr4.org
In this review we explore the past, present and future treatment of osteoarthritis using
autologous and allogeneic bone marrow mesenchymal stem cells (MSCs). Osteoarthritis is …
autologous and allogeneic bone marrow mesenchymal stem cells (MSCs). Osteoarthritis is …