GMP Cell and Gene Therapy

Publications

  • Kuhn S, Splith K, Ballschuh C, Feldbrügge L, Krenzien F, Atanasov G, Benzing C, Hau HM, Engelmann C, Berg T, Schulte Am Esch J, Pratschke J, Robson SC, Schmelzle M. Mononuclear-cell-derived microparticles attenuate endothelial inflammation by transfer of miR-142-3p in a CD39 dependent manner. Purinergic Signalling 14 (2018), 4, S. 423-432. dx.doi.org/10.1007/s11302-018-9624-5
  • Kebbel K. Technical challenges and requirements transferring an early ATMP from laboratory to authorized GMP manufacturing: A case study report. »The Product is the Process – Is it?« Qualitätsaspekte bei der Herstellung von ATMP, November 7, 2017, Berlin.
  • Wittke S, Baxmann S, Fahlenkamp D, Schmiedeknecht G, Kebbel K, Kießig ST. Rationales for a Multi-Epitope Approach in an Autologous Renal Cell Cancer Immunostimulant. J Vaccines Vaccin 2016, 7:4. DOI dx.doi.org/10.4172/2157-7560.1000327
  • Kebbel K. Obtaining a manufacturing license according to §13 AMG for an ATMP – How to get there? World Conference on Regenerative Medicine, Leipzig, Germany, October 21-23, 2015.
  • Schmiedeknecht G. Challenges of Manufacturing of ATMP’s for clinical trials. 2015 PDA Europe Conference Advanced Therapy Medicinal Products, Amsterdam, Netherlands, June 2–3, 2015.
  • Schmiedeknecht G. Challenges of Manufacturing of ATMP’s for clinical trials. World Conference on Regenerative Medicine, Leipzig, Germany, October 21-23, 2015.
  • Schmiedeknecht G. Besondere Herausforderungen bei der Herstellung von ATMP. »The Product is the Process – Is it?« Qualitätsaspekte bei der Herstellung von ATMP, November 4, 2014, Berlin.
  • Schmiedeknecht G. Translational research initiatives in Germany: Experiences on cell processing services. Clinical Evaluation, Vol. 42, No. 1, Jul. 2014, page 87-94.
  • Schmiedeknecht G, Kebbel K, Sonnabend C, Wagner M, Gryczka M, Stella M, Ganjei K, Bosch M, Powers LF. Process transfer of DCVax®-L to Europe and initiation of a phase III clinical trial in UK and Germany. ISCT (International Society for Cell Therapy) 2014 Annual Meeting, Paris, France, April 23–26, 2014.
  • Schmiedeknecht G, Kebbel K. Challenges of Manufacturing of ATMP’s for clinical trials. PACT (Platform for Advanced Cellular Therapies Austria) Foundation Symposium, Vienna, Austria, April 3–4, 2014.
  • Schmiedeknecht G. Translational Research Initiatives in Germany: Experiences on Cell Processing Services. Translational Research Center Workshop, organized by the Foundation for Biomedical Research and Innovation (FBRI) and Ministry of Education, Culture, Sports, Science and Technology (MEXT), Tokyo, Japan, February 27, 2014.
  • Haag M, Augst H, Kebbel K, Ringe J, Van Linthout S, Thielemann D, Kellert C, Schmiedeknecht G, Tschoepe C, Sittinger M. Human cardiac derived cells for the treatment of chronic heart failure - from bench to bedside. Kooperationsforum - Technologien für zellbasierte Therapien, Erlangen 2014, Tagungsband S. 118-19.
  • Buchholz M, Knauer J, Lehmann J, Haß M, Gargosky S. Qualification of the COSTIM assay to determine potency and use in clinical trials. ISCT (International Society for Cell Therapy) 2013 Annual Meeting, Auckland, New Zealand, April 22–25, 2013.
  • Polchow B, Kebbel K, Schmiedeknecht G, Reichardt A, Henrich W, Hetzer R, Lueders C. Cryopreservation of human vascular umbilical cord cells under good manufacturing practice conditions for future cell banks. J Transl Med. 2012; 10:98. doi: 10.1186/1479-5876-10-98.
  • Schmiedeknecht G. Clean rooms and technical equipment for the development of cell-based therapeutics. Contamination Control Report, 1, 2007, 44-47.