Biotechnology and Cytotherapeutics:The Swiss Progenitor-Cell Transplantation Program binocular: Comparison
View Latest Version
Please note this is a comparison between Version 3 by Amina Yu and Version 2 by Alexis Laurent.

Historically, primary human progenitor cells (e.g., WI-38 and MRC-5 diploid-cell sources) have been industrially applied in research and in manufacturing processes for vaccines and for biologicals. Furthermore, tissue-specific primary progenitor-cell banks have recently been developed and exploited for the provision of safe, consistent, and effective cellular active pharmaceutical ingredients (API) in homologous allogeneic regenerative medicine applications. Notably, the modern legal and regulatory frameworks for novel therapeutic products and for progenitor-cell therapy development have been iteratively optimized to guarantee utmost product safety, quality, and efficacy. Over 50 years of global technical hindsight around progenitor-cell biotechnological substrates and over 30 years of in-house clinical experience around the therapeutic uses of standardized progenitor-cell sources in Switzerland have demonstrated the importance of such biological materials for public health. The aim of this entry work was to summarize the evolution of the industrial applications of selected primary progenitor-cell sources, ranging from the use as robust biotechnological substrates to standardized cellular API manufacture and their clinical uses in highly specialized regenerative medicine.

  • biotechnological substrates
  • cell therapies
  • organ donation
  • pharmacopeial monographs
  • progen-itor cells
  • quality requirements
  • regenerative medicine
  • regulatory compliance
  • standardized transplants
  • vaccine substrates
Please wait, diff process is still running!

References

  1. Laurent, A.; Hirt-Burri, N.; Scaletta, C.; Michetti, M.; Raffoul, W.; de Buys Roessingh, A.S.; Applegate, L.A. Holistic approach of Swiss fetal progenitor cell banking: Optimizing safe and sustainable substrates for regenerative medicine and biotechnology. Front. Bioeng. Biotechnol. 2020, 8, 557758.
  2. Applegate, L.A.; Weber, D.; Simon, J.P.; Scaletta, C.; Hirt-Burri, N.; de Buys Roessingh, A.S.; Raffoul, W. Organ donation and whole-cell bioprocessing in the Swiss fetal progenitor cell transplantation platform. In Organ Donation and Organ Donors; Saidi, R.F., Ed.; Nova Science Publishers: New York, NY, USA, 2013; pp. 125–147. ISBN 978-1-62618-853-2.
  3. Hayflick, L.; Moorhead, P.S. The serial cultivation of human diploid cell strains. Exp. Cell Res. 1961, 25, 585–621.
  4. Hayflick, L. The limited in vitro lifetime of human diploid cell strains. Exp. Cell Res. 1965, 37, 614–636.
  5. Jacobs, J.P.; Jones, C.M.; Baille, J.P. Characteristics of a human diploid cell designated MRC-5. Nature 1970, 227, 168–170.
  6. Laurent, A.; Abdel-Sayed, P.; Hirt-Burri, N.; Scaletta, C.; Michetti, M.; de Buys Roessingh, A.; Raffoul, W.; Applegate, L.A. Evolution of diploid progenitor lung cell applications: From optimized biotechnological substrates to potential active pharmaceutical ingredients in respiratory tract regenerative medicine. Cells 2021, 10, 2526.
  7. Olshansky, S.J.; Hayflick, L. The role of the WI-38 cell strain in saving lives and reducing morbidity. AIMS Public Health 2017, 4, 127–138.
  8. Hayflick, L. A novel technique for transforming the theft of mortal human cells into praiseworthy federal policy. Exp. Gerontol. 1998, 33, 191–207.
  9. Furton, E.J. Vaccines originating in abortion. Ethics Med. 1999, 24, 3–4.
  10. Maher, D.P.; Panicola, M.R.; Harte, C. Vaccines, abortions and moral coherence. Nat. Cathol. Bioethics Q. 2002, 2, 51–67.
  11. Rudd, G. Is vaccination complicit with abortion? Ann. Pharmacother. 2003, 37, 1340–1341.
  12. Ehreth, J. The global value of vaccination. Vaccine 2003, 21, 596–600.
  13. Pruss, A.R. Cooperation with past evil and use of cell-lines derived from aborted fetuses. Linacre Q. 2004, 71, 335–350.
  14. Leiva, R. Moral reflections on vaccines prepared from cells derived from aborted human fetuses. Nat. Cathol. Bioethics Q. 2006, 6, 541.
  15. Rodriguez Luno, A. Ethical reflections on vaccines using cells from aborted fetuses. Nat. Cathol. Bioethics Q. 2006, 6, 453–459.
  16. Norrby, E.; Prusiner, S.B. Polio and Nobel prizes: Looking back 50 years. Ann. Neurol. 2007, 61, 385–395.
  17. Ma, B.; He, L.F.; Zhang, Y.L.; Chen, M.; Wang, L.L.; Yang, H.W.; Yan, T.; Sun, M.X.; Zheng, C.Y. Characteristics and viral propagation properties of a new human diploid cell line, Walvax-2, and its suitability as a candidate cell substrate for vaccine production. Hum. Vaccines Immunother. 2015, 11, 998–1009.
  18. WHO Expert Committee on Biological Standardization. Recommendations for the Evaluation of Animal Cell Cultures as Substrates for the Manufacture of Biological Medicinal Products and for the Characterization of Cell Banks. Sixty-First Report, Annex 3; WHO Technical Report Series No. 978; World Health Organization: Geneva, Switzerland, 2013.
  19. Hawkins, R.; Stylianou, M. Expert Committee on Biological Standardization, Second replacement seed stock for MRC-5 cells. In Proposal for WHO Reference Cell Bank Status; WHO/BS/2018.2347; World Health Organization: Geneva, Switzerland, 2018.
  20. Laurent, A.; Lin, P.; Scaletta, C.; Hirt-Burri, N.; Michetti, M.; de Buys Roessingh, A.S.; Raffoul, W.; She, B.R.; Applegate, L.A. Bringing safe and standardized cell therapies to industrialized processing for burns and wounds. Front. Bioeng. Biotechnol. 2020, 8, 581.
  21. Vetro, S.W.; Bellanti, J.A. Fetal and neonatal immunoincompetence. Fetal Diagn. Ther. 1989, 4, 82–91.
  22. Abbaspanah, B.; Momeni, M.; Ebrahimi, M.; Mousavi, S.H. Advances in perinatal stem cells research: A precious cell source for clinical applications. Regen. Med. 2018, 13, 595–610.
  23. Bhattacharya, N. Fetal cell/tissue therapy in adult disease: A new horizon in regenerative medicine. Clin. Exp. Obstet. Gynecol. 2004, 31, 167–173.
  24. Clarkson, E.D. Fetal tissue transplantation for patients with Parkinson’s disease: A database of published clinical results. Drugs Aging 2001, 18, 773–785.
  25. Gaggi, G.; Izzicupo, P.; Di Credico, A.; Sancilio, S.; Di Baldassarre, A.; Ghinassi, B. Spare parts from discarded materials: Fetal annexes in regenerative medicine. Int. J. Mol. Sci. 2019, 20, 1573.
  26. Kaviani, A.; Guleserian, K.; Perry, T.E.; Jennings, R.W.; Ziegler, M.M.; Fauza, D.O. Fetal tissue engineering from amniotic fluid. J. Am. Coll. Surg. 2003, 196, 592–597.
  27. Kaviani, A.; Perry, T.E.; Barnes, C.M.; Oh, J.T.; Ziegler, M.M.; Fishman, S.J.; Fauza, D.O. The placenta as a cell source in fetal tissue engineering. J. Pediatr. Surg. 2002, 37, 995–999.
  28. Laurent, A.; Scaletta, C.; Hirt-Burri, N.; Raffoul, W.; de Buys Roessingh, A.S.; Applegate, L.A. Swiss fetal transplantation program and nonenzymatically isolated primary progenitor cell types for regenerative medicine. In Stem Cells and Good Manufacturing Practices: Methods and Protocols; Kursad, T., Ed.; Springer Science+Business Media: New York, NY, USA, 2020.
  29. Beskow, L.M. Lessons from HeLa cells: The ethics and policy of biospecimens. Annu. Rev. Genom. Hum. Genet. 2016, 17, 395–417.
  30. Johnson, P.C.; Bertram, T.A.; Tawil, B.; Hellman, K.B. Hurdles in tissue engineering/regenerative medicine product commercialization: A survey of North American academia and industry. Tissue Eng. Part A 2011, 17, 5–15.
  31. Bertram, T.A.; Tentoff, E.; Johnson, P.C.; Tawil, B.; Van Dyke, M.; Hellman, K.B. Hurdles in tissue engineering/regenerative medicine product commercialization: A pilot survey of governmental funding agencies and the financial industry. Tissue Eng. Part A 2012, 18, 2187–2194.
  32. Pirnay, J.P.; Vanderkelen, A.; De Vos, D.; Draye, J.P.; Rose, T.; Ceulemans, C.; Ectors, N.; Huys, I.; Jennes, S.; Verbeken, G. Business oriented EU human cell and tissue product legislation will adversely impact Member States’ health care systems. Cell. Tissue Bank. 2013, 14, 525–560.
  33. Pearce, K.F.; Hildebrandt, M.; Greinix, H.; Scheding, S.; Koehl, U.; Worel, N.; Apperley, J.; Edinger, M.; Hauser, A.; Mischak-Weissinger, E.; et al. Regulation of advanced therapy medicinal products in Europe and the role of academia. Cytotherapy 2014, 16, 289–297.
  34. Ramezankhani, R.; Torabi, S.; Minaei, N.; Madani, H.; Rezaeiani, S.; Hassani, S.N.; Gee, A.P.; Dominici, M.; Silva, D.N.; Baharvand, H.; et al. Two decades of global progress in authorized advanced therapy medicinal products: An emerging revolution in therapeutic strategies. Front. Cell Dev. Biol. 2020, 8, 547653.
  35. Dimitropoulos, G.; Jafari, P.; de Buys Roessingh, A.; Hirt-Burri, N.; Raffoul, W.; Applegate, L.A. Burn patient care lost in good manufacturing practices? Ann. Burn. Fire Disasters 2016, 29, 111–115.
  36. Hartmann-Fritsch, F.; Marino, D.; Reichmann, E. About ATMPs, SOPs and GMP: The hurdles to produce novel skin grafts for clinical use. Transfus. Med. Hemother. 2016, 43, 344–352.
  37. De Wilde, S.; Veltrop-Duits, L.; Hoozemans-Strik, M.; Ras, T.; Blom-Veenman, J.; Guchelaar, H.J.; Zandvliet, M.; Meij, P. Hurdles in clinical implementation of academic advanced therapy medicinal products: A national evaluation. Cytotherapy 2016, 18, 797–805.
  38. Hohlfeld, J.; de Buys Roessingh, A.S.; Hirt-Burri, N.; Chaubert, P.; Gerber, S.; Scaletta, C.; Hohlfeld, P.; Applegate, L.A. Tissue engineered fetal skin constructs for pediatric burns. Lancet 2005, 366, 840–842.
  39. Hirt-Burri, N.; Ramelet, A.A.; Raffoul, W.; de Buys Roessingh, A.S.; Scaletta, C.; Pioletti, D.P.; Applegate, L.A. Biologicals and fetal cell therapy for wound and scar management. ISRN Dermatol. 2011, 2011, 549870.
  40. De Buys Roessingh, A.S.; Hirt-Burri, N.; Raffoul, W.; Scaletta, C.; Applegate, L.A. A decade after foetal skin progenitor cell therapy in pediatric burn treatment. J. Regen. Med. 2015, 4, 1.
  41. Al-Dourobi, K.; Laurent, A.; Deghayli, L.; Flahaut, M.; Abdel-Sayed, P.; Scaletta, C.; Michetti, M.; Waselle, L.; Simon, J.P.; Ezzi, O.E.; et al. Retrospective evaluation of progenitor biological bandage use: A complementary and safe therapeutic management option for prevention of hypertrophic scarring in pediatric burn care. Pharmaceuticals 2021, 14, 201.
  42. Abdel-Sayed, P.; Hirt-Burri, N.; de Buys Roessingh, A.S.; Raffoul, W.; Applegate, L.A. Evolution of biological bandages as first cover for burn patients. Adv. Wound Care 2019, 8, 555–564.
  43. Ramelet, A.A.; Hirt-Burri, N.; Raffoul, W.; Scaletta, C.; Pioletti, D.P.; Offord, E.; Mansourian, R.; Applegate, L.A. Chronic wound healing by fetal cell therapy may be explained by differential gene profiling observed in fetal versus old skin cells. Exp. Gerontol. 2009, 44, 208–218.
  44. Quintin, A.; Hirt-Burri, N.; Scaletta, C.; Schizas, C.; Pioletti, D.P.; Applegate, L.A. Consistency and safety of cell banks for research and clinical use: Preliminary analysis of fetal skin banks. Cell Transplant. 2007, 16, 675–684.
  45. Darwiche, S.E.; Scaletta, C.; Raffoul, W.; Pioletti, D.P.; Applegate, L.A. Epiphyseal chondroprogenitors provide a stable cell source for cartilage cell therapy. Cell Med. 2012, 4, 23–32.
  46. Grognuz, A.; Scaletta, C.; Farron, A.; Raffoul, W.; Applegate, L.A. Human fetal progenitor tenocytes for regenerative medicine. Cell Transplant. 2016, 25, 463–479.
  47. Laurent, A.; Darwiche, S.E.; Hirt-Burri, N.; Scaletta, C.; Michetti, M.; Laurent, P.; Raffoul, W.; de Buys Roessingh, A.S.; Applegate, L.A. Banking progenitor cells for hippiatric regenerative medicine: Optimized establishment of safe and consistent cell sources for standardized veterinary therapeutic protocols. AJBSR 2020, 8, 252–271.
  48. Hirt-Burri, N.; de Buys Roessingh, A.S.; Scaletta, C.; Gerber, S.; Pioletti, D.P.; Applegate, L.A.; Hohlfeld, J. Human muscular fetal cells: A potential cell source for muscular therapies. Pediatr. Surg. Int. 2008, 24, 37–47.
  49. Quintin, A.; Schizas, C.; Scaletta, C.; Jaccoud, S.; Gerber, S.; Osterheld, M.C.; Jullierat, L.; Applegate, L.A.; Pioletti, D.P. Isolation and in vitro chondrogenic potential of human foetal spine cells. J. Cell Mol. Med. 2009, 13, 2559–2569.
  50. Montjovent, M.O.; Burri, N.; Mark, S.; Federici, E.; Scaletta, C.; Zambelli, P.Y.; Hohlfeld, P.; Leyvraz, P.F.; Applegate, L.A.; Pioletti, D.P. Fetal bone cells for tissue engineering. Bone 2004, 35, 1323–1333.
  51. Laurent, A.; Scaletta, C.; Abdel-Sayed, P.; Michetti, M.; Flahaut, M.; Simon, J.P.; de Buys Roessingh, A.S.; Raffoul, W.; Hirt-Burri, N.; Applegate, L.A. Optimized manufacture of lyophilized dermal fibroblasts for next-generation off-the-shelf progenitor biological bandages in topical post-burn regenerative medicine. Biomedicines 2021, 9, 1072.
  52. Laurent, A.; Abdel-Sayed, P.; Ducrot, A.; Hirt-Burri, N.; Scaletta, C.; Jaccoud, S.; Nuss, K.; de Buys Roessingh, A.S.; Raffoul, W.; Pioletti, D.P.; et al. Development of standardized fetal progenitor cell therapy for cartilage regenerative medicine: Industrial transposition and preliminary safety in xenogeneic transplantation. Biomolecules 2021, 11, 250.
  53. Laurent, A.; Abdel-Sayed, P.; Grognuz, A.; Scaletta, C.; Hirt-Burri, N.; Michetti, M.; de Buys Roessingh, A.S.; Raffoul, W.; Kronen, P.; Nuss, K.; et al. Industrial development of standardized fetal progenitor cell therapy for tendon regenerative medicine: Preliminary safety in xenogeneic transplantation. Biomedicines 2021, 9, 380.
  54. European Parliament and Council. Directive 2004/23/EC on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells. Off. J. Eur. Union 2004, L 102, 48–58. Available online: http://data.europa.eu/eli/dir/2004/23/oj (accessed on 1 December 2021).
  55. European Commission. Commission Directive (EC) No 2006/17/EC of 8 February 2006 implementing Directive 2004/23/EC of the European parliament and of the Council as regards certain technical requirements for the donation, procurement and testing of human tissues and cells. Off. J. Eur. Union 2006, L38, 40–52. Available online: http://data.europa.eu/eli/dir/2006/17/oj (accessed on 1 December 2021).
  56. European Commission. Commission Directive (EC) No 2006/86/EC of 24 October 2006 implementing Directive 2004/23/EC of the European parliament and of the Council as regards traceability requirements, notification of serious adverse reactions and events and certain technical requirements for the coding, processing, preservation, storage and distribution of human tissues and cells. Off. J. Eur. Union 2006, L294, 32–50. Available online: http://data.europa.eu/eli/dir/2006/86/oj (accessed on 1 December 2021).
  57. European Directorate for the Quality of Medicines & Healthcare. European Committee (Partial Agreement) on organ transplantation (CD-P-TO). In Guide to the Quality and Safety of Tissues and Cells for Human Application, 4th ed.; EDQM: Strasbourg, France, 2019; ISBN 978-92-871-8945-5.
  58. Federal Assembly of the Swiss Confederation. Federal Act on Medicinal Products and Medical Devices (Therapeutic Products Act, TPA). SR 812.21. 2000. Available online: https://fedlex.data.admin.ch/eli/cc/2001/422 (accessed on 1 December 2021).
  59. Federal Assembly of the Swiss Confederation. Federal Act on the Transplantation of Organs, Tissues and Cells (Transplantation Act). SR 810.21. 2004. Available online: https://fedlex.data.admin.ch/eli/cc/2007/279 (accessed on 1 December 2021).
  60. Center for Biologics Evaluation and Research, US Food and Drug Administration. Guidance for Industry on Characterization and Qualification of Cell Substrates and other Biological Materials Used in the Production of Viral Vaccines for Infectious Disease Indications; FDA: Silver Spring, MD, USA, 2010.
  61. European Medicines Agency. ICH Topic Q 5 A (R1). Quality of Biotechnological Products: Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin; CPMP/ICH/295/95; European Medicines Agency: Amsterdam, The Netherlands, 1997.
  62. European Medicines Agency. ICH Topic Q 5 D. Quality of Biotechnological Products: Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products; CPMP/ICH/294/95; European Medicines Agency: Amsterdam, The Netherlands, 1998.
  63. World Health Organization. Application of Hazard Analysis and Critical Control Point (HACCP) Methodology to Pharmaceuticals; WHO Technical Report Series No. 908; World Health Organisation: Geneva, Switzerland, 2003.
  64. Dahiya, S.; Khar, R.; Chhikara, A. Opportunities, challenges and benefits of using HACCP as a quality risk management tool in the pharmaceutical industry. Qual. Assur. J. 2009, 12, 95–104.
  65. European Directorate for the Quality of Medicines & Healthcare. General Chapter 5.2.3. Cell Substrates for the Production of Vaccines for Human Use. In European Pharmacopoeia 9.0; EDQM: Strasbourg, France, 2017.
  66. Laurent, A.; Scaletta, C.; Michetti, M.; Hirt-Burri, N.; de Buys Roessingh, A.S.; Raffoul, W.; Applegate, L.A. GMP tiered cell banking of non-enzymatically isolated dermal progenitor fibroblasts for allogenic regenerative medicine. In Stem Cells and Good Manufacturing Practices: Methods and Protocols; Kursad, T., Ed.; Springer Science+Business Media: New York, NJ, USA, 2020.
  67. European Directorate for the Quality of Medicines & Healthcare. General Chapter 5.2.1. Terminology Used in Monographs on Biological Products. In European Pharmacopoeia 9.0; EDQM: Strasbourg, France, 2017.
  68. Zhang, K.; Na, T.; Wang, L.; Gao, Q.; Yin, W.; Wang, J.; Yuan, B.Z. Human diploid MRC-5 cells exhibit several critical properties of human umbilical cord-derived mesenchymal stem cells. Vaccine 2014, 32, 6820–6827.
  69. Hayflick, L.; Plotkin, S.A.; Norton, T.W.; Koprowski, H. Preparation of poliovirus vaccines in a human fetal diploid cell strain. Am. J. Hyg. 1962, 75, 240–258.
  70. Jordan, I.; Sandig, V. Matrix and backstage: Cellular substrates for viral vaccines. Viruses 2014, 6, 1672–1700.
  71. European Parliament and Council. Directive 2001/83/EC on the Community code relating to medicinal products for human use. Off. J. Eur. Union 2001, L311, 67–128. Available online: http://data.europa.eu/eli/dir/2001/83/oj (accessed on 1 December 2021).
  72. European Parliament and Council. Regulation (EC) No 726/2004 laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency. Off. J. Eur. Union 2004, L136, 1–33. Available online: http://data.europa.eu/eli/reg/2004/726/oj (accessed on 1 December 2021).
  73. Klykens, J.; Pirnay, J.P.; Verbeken, G.; Giet, O.; Baudoux, E.; Jashari, R.; Vanderkelen, A.; Ectors, N. Cleanrooms and tissue banking how happy I could be with either GMP or GTP? Cell. Tissue Bank. 2013, 14, 571–578.
  74. European Commission. Commission Directive (EC) No 2003/94/EC of 8 October 2003 laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use. Off. J. Eur. Union 2003, L262, 22–26. Available online: http://data.europa.eu/eli/dir/2003/94/oj (accessed on 1 December 2021).
  75. European Medicines Agency. ICH Topic Q 7. Good Manufacturing Practice for Active Pharmaceutical Ingredients; CPMP/ICH/4106/00; European Medicines Agency: Amsterdam, The Netherlands, 2000.
  76. European Medicines Agency. Re-Establishment of Working Seeds and Working Cell Banks Using TSE Compliant Materials; EMEA/22314/02; European Medicines Agency: Amsterdam, The Netherlands, 2002.
  77. European Medicines Agency. Guideline on the Use of Porcine Trypsin Used in the Manufacture of Human Biological Medicinal Products; EMA/CHMP/BWP/814397/2011; European Medicines Agency: Amsterdam, The Netherlands, 2014.
  78. European Medicines Agency. Note for Guidance on the Use of Bovine Serum in the Manufacture of Human Biological Medicinal Products; CPMP/BWP/1793/02; European Medicines Agency: Amsterdam, The Netherlands, 2003.
  79. European Medicines Agency. ICH Topic Q 5 E. Note for Guidance on Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process; CPMP/ICH/5721/03; European Medicines Agency: Amsterdam, The Netherlands, 2005.
  80. European Medicines Agency. ICH Topic Q 9. Guideline on Quality Risk Management; EMA/CHMP/ICH/24235/2006; European Medicines Agency: Amsterdam, The Netherlands, 2015.
  81. European Medicines Agency. ICH Topic Q 10. Guideline on Pharmaceutical Quality System; EMA/CHMP/ICH/214732/2007; European Medicines Agency: Amsterdam, The Netherlands, 2015.
  82. US Food and Drug Administration. Points to Consider in the Characterization of Cell Lines Used to Produce Biologicals; FDA: Silver Spring, MD, USA, 1993.
  83. European Medicines Agency. ICH Topic Q 6 B. Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products; CPMP/ICH/365/96; European Medicines Agency: Amsterdam, The Netherlands, 1999.
  84. European Medicines Agency. ICH Topic Q 5 C. Stability Testing of Biotechnological/Biological Products; CPMP/ICH/138/95; European Medicines Agency: Amsterdam, The Netherlands, 1996.
  85. European Medicines Agency. Guideline on Risk Management Systems for Medicinal Products for Human Use; EMEA/CHMP/96268/2005; European Medicines Agency: Amsterdam, The Netherlands, 2005.
  86. European Parliament and Council. Regulation (EC) No 1394/2007 on Advanced Therapy Medicinal Products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004. Off. J. Eur. Union 2007, L324, 121–137. Available online: http://data.europa.eu/eli/reg/2007/1394/oj (accessed on 1 December 2021).
  87. Committee for Medicinal Product for Human Use. Guideline on Human Cell-Based Medicinal Products; EMEA/CHMP/410869/2006; European Medicines Agency: Amsterdam, The Netherlands, 2008.
  88. European Commission. EudraLex, the Rules Governing Medicinal Products in the European Union, Volume 4, Good Manufacturing Practice, Guidelines of 22.11.2017, Good Manufacturing Practice for Advanced Therapy Medicinal Products. 2017. Available online: https://ec.europa.eu/health/documents/eudralex/vol-4_en (accessed on 1 December 2021).
  89. European Medicines Agency. Creutzfeldt-Jakob Disease and Advanced Therapy Medicinal Products; EMA/CHMP/BWP/353632/2010; European Medicines Agency: Amsterdam, The Netherlands, 2011.
  90. Hunsberger, J.; Harrysson, O.; Shirwaiker, R.; Starly, B.; Wysk, R.; Cohen, P.; Allikson, J.; Yoo, J.; Atala, A. Manufacturing road map for tissue engineering and regenerative medicine technologies. Stem Cells Transl. Med. 2015, 4, 130–135.
  91. Addor, V.; Narring, F.; Michaud, P.A. Abortion trends 1990–1999 in a Swiss region and determinants of abortion recurrence. Swiss Med. Wkly. 2003, 133, 219–226.
  92. World Medical Association. Declaration of Helsinki: Ethical principles for medical research involving human subjects. JAMA 2013, 310, 2191–2194.
  93. Laurent, A.; Simon, J.P.; Hirt-Burri, N.; Raffoul, W.; Applegate, L.A.; de Buys Roessingh, A.S. GMP-grade allogeneic musculoskeletal primary progenitor cell types: Standardized candidates for general or pharmacopeial monograph elaboration. J. Transl. Sci. 2020, 7, 1–3.
  94. Jeannerat, A.; Peneveyre, C.; Armand, F.; Chiappe, D.; Hamelin, R.; Scaletta, C.; Hirt-Burri, N.; de Buys Roessingh, A.; Raffoul, W.; Applegate, L.A.; et al. Hypoxic incubation conditions for optimized manufacture of tenocyte-based active pharmaceutical ingredients of homologous standardized transplant products in tendon regenerative medicine. Cells 2021, 10, 2872.
  95. Bari, E.; Ferrarotti, I.; Torre, M.L.; Corsico, A.G.; Perteghella, S. Mesenchymal stem/stromal cell secretome for lung regeneration:. The long way through “pharmaceuticalization” for the best formulation. J. Control. Release 2019, 309, 11–24.
  96. Sengupta, V.; Sengupta, S.; Lazo, A.; Woods, P.; Nolan, A.; Bremer, N. Exosomes derived from bone marrow mesenchymal stem cells as treatment for severe COVID-19. Stem Cells Dev. 2020, 29, 747–754.
  97. Chemali, M.; Laurent, A.; Scaletta, C.; Waselle, L.; Simon, J.P.; Michetti, M.; Brunet, J.F.; Flahaut, M.; Hirt-Burri, N.; Raffoul, W.; et al. Burn center organization and cellular therapy integration: Managing risks and costs. J. Burn Care Res. 2021, 42, 911–924.
  98. Vacanti, J.P.; Langer, R. Tissue engineering: The design and fabrication of living replacement devices for surgical reconstruction and transplantation. Lancet 1999, 354 (Suppl. 1), S32–S34.
  99. European Directorate for the Quality of Medicines & Healthcare. European Pharmacopoeia 9.0 Monograph 2323. Human Hematopoietic Stem Cells; EDQM: Strasbourg, France, 2017.
  100. Verbeken, G.; Draye, J.P.; Fauconnier, A.; Vanlaere, I.; Huys, I.; De Corte, P.; Verween, G.; Pascual, B.; Delmotte, N.; Pierlot, A.; et al. The magistral preparation of Advanced Therapy Medicinal Products (ATMPs). J. Surg. Pract. 2020, 2, 16.
  101. Pirnay, J.P.; Verbeken, G.; Ceyssens, P.J.; Huys, I.; De Vos, D.; Ameloot, C.; Fauconnier, A. The magistral phage. Viruses 2018, 10, 64.
  102. Bicudo, E.; Brass, I.; Carmichael, P.; Farid, S. The UK’s emerging regulatory framework for point-of-care manufacture: Insights from a workshop on advanced therapies. Cell Gene Ther. Insights 2021, 7, 1005–1015.
  103. Hausherr, T.C.; Nuss, K.; Thein, E.; Applegate, L.A.; Pioletti, D.P. Human bone progenitor cells for clinical application: What kind of immune reaction does fetal xenograft tissue trigger in immunocompetent rats? Cell Transplant. 2017, 26, 879–890.
  104. Laurent, A.; Hirt-Burri, N.; Amiot, C.; Scaletta, C.; Applegate, L.A.; de Buys Roessingh, A.S. Primary progenitor muscle cells for regenerative medicine: Standardization of therapeutic protocols and optimized in vivo murine model for volumetric muscle loss. AJBSR 2020, 8, 143–153.
  105. Laurent-Applegate, L.A. Preparation of Parental Cell Bank from Foetal Tissue. European Patent No 2,732,030,B1, 3 July 2012. Available online: https://patents.google.com/patent/US9434923B2/en (accessed on 1 December 2021).
More
© Text is available under the terms and conditions of the Creative Commons Attribution (CC BY) license (http://creativecommons.org/licenses/by/4.0/)
Video Production Service
Feedback