Zobrazeno 1 - 10
of 28
pro vyhledávání: '"Paula Salmikangas"'
Publikováno v:
Frontiers in Medicine, Vol 10 (2023)
Potency is one of the critical quality attributes of biological medicinal products, defining their biological activity. Potency testing is expected to reflect the Mechanism of Action (MoA) of the medicinal product and ideally the results should corre
Externí odkaz:
https://doaj.org/article/14fdeeae69584d1594634c6eb0a200ce
Autor:
Marc Baay, Pieter Neels, Paula Salmikangas, Carine La, Jeffrey M. Bethony, Isabelle Bekeredjian-Ding, Eric Karikari-Boateng, Alan W. Bell, Pauline Meij, Alex Mann, Winfred Badanga Nazziwa, Akamol E. Suvarnapunya, Linda Schellhaas, Jean-Hugues Trouvin, Hilde Depraetere, Wim Van Molle, Dean Smith, Peter Stjärnkvist, Jetsumon Prachumsri
Publikováno v:
Biologicals, 74:16-23
Biologicals, 74, 16-23. ACADEMIC PRESS LTD-ELSEVIER SCIENCE LTD
Biologicals, 74, 16-23. ACADEMIC PRESS LTD-ELSEVIER SCIENCE LTD
There is an increasing need to establish quality principles for designing, developing and manufacturing challenge agents as currently these agents are classified differently by various jurisdictions. Indeed, considerations for challenge agent manufac
Publikováno v:
Cell and Gene Therapy Insights. 5:829-857
Autor:
Bernd Gansbacher, Michele Lipucci di Paola, Nicolas Ferry, Ilona Reischl, Paula Salmikangas, Margarida Menezes-Ferreira, Dariusz Sladowski, Patrick Celis, Tomáš Boráň, Hartmut Krafft
Publikováno v:
Human Gene Therapy Clinical Development. 28:126-135
The research and development of advanced therapy medicinal products (ATMPs) has been active in Europe and worldwide during recent years. Yet, the number of licensed products remains low. The main expected legal change in the near future in the Europe
Publikováno v:
Pharmaceutical Research
The first CD19 CAR T-cell products, Kymriah and Yescarta, are entering the US market and also being evaluated for marketing authorization in the EU. This breakthrough has expanded the interest and also investments towards novel chimeric antigen recep
Autor:
Pieter A. Doevendans, Veronika Jekerle, Claire Beuneu, Romaldas Mačiulaitis, Jonathan Hill, Paula Salmikangas, Stefan Jovinge, Metoda Lipnik-Stangelj, Olli Tenhunen, Marit Hystad, Giuseppe Rosano, Jan Kyselovic, Anthony Samuel, Patrick Celis, Krishna Prasad, Maura O'Donovan, Andreas M. Zeiher, Jozef Bartunek, Margarida Menezes-Ferreira, Torsten Tonn, Steven A. J. Chamuleau, Martina Schüssler-Lenz
Publikováno v:
European Journal of Heart Failure. 18:133-141
In the past decade, novel cell-based products have been studied in patients with acute and chronic cardiac disease to assess whether these therapies are efficacious in improving heart function and preventing the development of end-stage heart failure
Autor:
Metoda Lipnik-Stangelj, Patrick Celis, Ilona Reischl, Paula Salmikangas, Jean-Hugues Trouvin, Guido Pante, Janis Ancans, Sol Ruiz, Egbert Flory, Asterios S. Tsiftsoglou, Margarida Menezes-Ferreira, Jan Kyselovic, John Joseph Borg, Marcos Timon, Christian Schneider, Dariusz Sladowski
Publikováno v:
Regenerative Medicine. 10:65-78
During the past decade, a large number of cell-based medicinal products have been tested in clinical trials for the treatment of various diseases and tissue defects. However, licensed products and those approaching marketing authorization are still f
Autor:
Anthony Ridgway, Nobuo Kanai, Yi-Chu Lin, James W. McBlane, Akihiro Umezawa, Paula Salmikangas, Matthias Renner, Yuzo Toda, Norihisa Sakamoto, Yoshiaki Maruyama, Michael Werner, Jeewon Joung, Yoji Sato, Srinivasan N. Kellathur, Stephen Wicks, Daisaku Sato, Ian Ross Harris, Takao Hayakawa, Junichi Koga, Shin Kawamata, Takuya Nishimura
Publikováno v:
Biologicals : journal of the International Association of Biological Standardization. 44(5)
The development of human cell therapy and gene therapy products has progressed internationally. Efforts have been made to address regulatory challenges in the evaluation of quality, efficacy, and safety of the products. In this forum, updates on the
Autor:
Paula, Salmikangas, Martina, Schuessler-Lenz, Sol, Ruiz, Patrick, Celis, Ilona, Reischl, Margarida, Menezes-Ferreira, Egbert, Flory, Matthias, Renner, Nicolas, Ferry
Publikováno v:
Advances in experimental medicine and biology. 871
With the release of Regulation 1394/2007, a new framework for gene and cell therapy medicinal products and tissue-engineered products was established in the European Union. For all three product classes, called advanced therapy medicinal products, a
Autor:
Patrick Celis, Sol Ruiz, Nicolas Ferry, Paula Salmikangas, Ilona Reischl, Matthias Renner, Egbert Flory, Margarida Menezes-Ferreira, Martina Schuessler-Lenz
Publikováno v:
Advances in Experimental Medicine and Biology ISBN: 9783319186177
With the release of Regulation 1394/2007, a new framework for gene and cell therapy medicinal products and tissue-engineered products was established in the European Union. For all three product classes, called advanced therapy medicinal products, a
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::73f7da5170eebb988cd5273d403d9528
https://doi.org/10.1007/978-3-319-18618-4_6
https://doi.org/10.1007/978-3-319-18618-4_6