Clinical Development of Cell Therapies: Setting the Stage for Academic Success

Clinical Pharmacology and Therapeutics

Volumn 101, Issue 1, 2017, Pages 35-38

  Abou El Enein, M ^a   Volk, H D ^a   Reinke, P ^a  

^a CHARITÉ UNIVERSITÄTSMEDIZIN BERLIN   (Germany)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; CELL THERAPY; HUMAN; IMMUNOTHERAPY; NONHUMAN; ORGAN TRANSPLANTATION; PRIORITY JOURNAL; PRODUCT DEVELOPMENT; REGULATORY T LYMPHOCYTE; ANIMAL; BIOLOGICAL THERAPY; CLINICAL TRIAL (TOPIC); HEALTH SERVICE; PROCEDURES; TRANSLATIONAL RESEARCH;

ANIMALS; CELL- AND TISSUE-BASED THERAPY; CLINICAL TRIALS AS TOPIC; HEALTH SERVICES NEEDS AND DEMAND; HUMANS; IMMUNOTHERAPY; TRANSLATIONAL MEDICAL RESEARCH;

EID: 85005938334     PISSN: 00099236     EISSN: 15326535     Source Type: Journal    
DOI: 10.1002/cpt.523     Document Type: Article

References (6)

1. Landwehr-Kenzel, S. et al. Novel GMP-compatible protocol employing an allogeneic B cell bank for clonal expansion of allospecific natural regulatory T cells. Am. J. Transplant. 14, 594–606 (2014).
2. Siepert, A. et al. Permanent CNI treatment for prevention of renal allograft rejection in sensitized hosts can be replaced by regulatory T cells. Am. J. Transplant. 12, 2384–2394 (2012).
3. Juvet, S.C., Whatcott, A.G., Bushell, A.R. & Wood, K.J. Harnessing regulatory T cells for clinical use in transplantation: the end of the beginning. Am. J. Transplant. 14, 750–763 (2014).
4. Abou-El-Enein, M. et al. Good Manufacturing Practices (GMP) manufacturing of advanced therapy medicinal products: a novel tailored model for optimizing performance and estimating costs. Cytotherapy 15, 362–383 (2013).
5. European Medicines Agency. Concept paper on the revision of the “Guideline on Strategies to Identify and Mitigate Risks for First-in-Human Clinical Trials With Investigational Medicinal Products” (EMEA/CHMP/SWP/28367/07). .
6. Abou-El-Enein, M., Duda, G.N., Gruskin, E.A. & Grainger, D.W. Strategies for derisking translational processes for biomedical technologies. Trends Biotechnol. (2016); e-pub ahead of print.