Results 51 to 60 of about 9,951,844 (299)

Good manufacturing practices [PDF]

ISBT Science Series, 2009
GMP introduces the application of Quality assurance principles in all steps involved in the collection, preparation, testing and distribution activities. GMP resulting in an increase of the availability of blood products.
openaire   +1 more source

Good Manufacturing Practice-compliant human induced pluripotent stem cells: from bench to putative clinical products.

Cytotherapy
BACKGROUND AIMS Few human induced pluripotent stem cell (hiPSC) lines are Good Manufacturing Practice (GMP)-compliant, limiting the clinical use of hiPSC-derived products.
J. Novoa, Inge M Westra, E. Steeneveld, Natascha Fonseca Neves, Christiaan H. Arendzen, Bahareh Rajaei, Esmée Grundeken, M. Yildiz, Wouter H. van der Valk, Alison Salvador, F. Carlotti, P. Dijkers, Heiko Locher, Cathelijne W. van den Berg, K. Raymond, A. Kirkeby, C. Mummery, T. Rabelink, Christian Freund, P. Meij, Brigitte Wieles   +20 more
semanticscholar   +1 more source

GMP-Compliant Production of Autologous Adipose-Derived Stromal Cells in the NANT 001 Closed Automated Bioreactor

Frontiers in Bioengineering and Biotechnology, 2022
In recent years mesenchymal stromal cells (MSCs) have received a great deal of interest for the treatment of major diseases, but clinical translation and market authorization have been slow.
Joan C. Fitzgerald, Niamh Duffy, Giacomo Cattaruzzi, Francesco Vitrani, Alice Paulitti, Flavia Mazzarol, Prisca Mauro, Antonio Sfiligoj, Francesco Curcio, Deirdre M. Jones, Veronica McInerney, Janusz Krawczyk, Jack Kelly, Andrew Finnerty, Katya McDonagh, Una McCabe, Matthew Duggan, Lauren Connolly, Georgina Shaw, Mary Murphy, Frank Barry   +20 more
doaj   +1 more source

Critical Path to First-in-Human Batches of ChAdOx Vectors, Including for Emergency Response

Vaccines
Background: Adenovirus-vectored vaccines played an important role in the global response to SARS-CoV-2. Adenovirus platforms have many advantages including a simple and readily transferred manufacturing process, low cost, and thermostability.
Marco Polo Peralta Alvarez, Shawkat Hussain, Andrea Magri, Jacqueline Vieira, Cheelsea Pereira, Faith Vinluan, Matteo N. Barbaglia, Daniel Wright, Susan J. Morris, Emma Bolam, Eleanor Berrie, Teresa Lambe, Tanja Brenner, Richard Tarrant, Sarah C. Gilbert, Catherine M. Green, Alexander D. Douglas   +16 more
doaj   +1 more source

Allogenic and autologous nondiluted serum eye drops—validation strategy compliant with good manufacturing practice

Transfusion Medicine
Serum eye drops alleviate ocular symptoms of diseases such as sicca syndrome, or chronic graft‐versus‐host disease. This study was designed for good manufacturing practice validation of our standard manufacturing, storage and transport processes for both
F. Dormann, Viola Hähnel, Viktoria Müller, Ralph Burkhardt, R. Offner   +4 more
semanticscholar   +1 more source

Administering the Code of Good Manufacturing Practice for prescription medicines [PDF]

, 2014
This audit assessed the effectiveness of the Therapeutic Goods Administration’s application of the Code of Good Manufacturing Practice for prescription medicines.

core  

Establishing an Apheresis Medicine Program in a Resource‐Constrained Setting: A 5‐Year Experience From Lagos, Nigeria

Therapeutic Apheresis and Dialysis, EarlyView.
ABSTRACT Background Establishing a comprehensive apheresis medicine program in a resource‐constrained setting presents significant structural, financial, and logistical challenges. Despite the growing clinical importance of apheresis services globally, published experience from sub‐Saharan Africa remains sparse.
Folasade Adelekan‐Popoola, Shakirat Gold‐Olufadi, Olufunto Olufela Kalejaiye, Abdullateef Ogala, Rasheed A. Balogun   +4 more
wiley   +1 more source

Guide to REgional Good Practice eHealth

, 2007
This report shows the result of the work of IANIS+ eHealth work group (WG). The WG has collected regional eHealth experiences from around Europe through a number of activities: • Regional eHealth case studies of which 17 (from 15 regions) are shown in ...
Bai, Guohua, Malmqvist, Gustav
core   +2 more sources

An epithelial GPR35 isoform supports tumor‐associated transcriptional and metabolic phenotypes

FEBS Letters, EarlyView.
GPR35 generates two functionally distinct isoforms with previously unresolved roles. GPR35‐short mediates immune‐cell chemotaxis, while GPR35‐long is enriched in colorectal cancer epithelium, where it supports increased metabolism, proliferation, and tumor‐associated transcriptional programs.
Jørgen D. Rønneberg, Martine Hjeltnes, Josephine Krieger, Joshua E. Elias, Maria Stensland, Kristian Holm, Xiaojun Jiang, Chuki Khangsar, Tuula A. Nyman, Arthur Kaser, Johannes R. Hov, Tom H. Karlsen, Nicole C. Kaneider, Frode L. Jahnsen, Georg Schneditz   +14 more
wiley   +1 more source

Risk Management in Good Manufacturing Practice (GMP) Radiopharmaceutical Preparations

Applied Sciences
Risk assessment and management during the entire production process of a radiopharmaceutical are pivotal factors in ensuring drug safety and quality.
Michela Poli, Mauro Quaglierini, Alessandro Zega, Silvia Pardini, Mauro Telleschi, Giorgio Iervasi, Letizia Guiducci   +6 more
doaj   +1 more source