Comparability: manufacturing, characterization and controls, report of a UK Regenerative Medicine Platform Pluripotent Stem Cell Platform Workshop, Trinity Hall, Cambridge, 14–15 September 2015-Reference-Cited by-同舟云学术

Comparability: manufacturing, characterization and controls, report of a UK Regenerative Medicine Platform Pluripotent Stem Cell Platform Workshop, Trinity Hall, Cambridge, 14–15 September 2015

Published:2016-07 Issue:5 Volume:11 Page:483-492
ISSN:1746-0751
Container-title:Regenerative Medicine
language:en
Short-container-title:Regenerative Medicine

Author:

Williams David J¹,Archer Richard²,Archibald Peter¹,Bantounas Ioannis³,Baptista Ricardo⁴,Barker Roger⁵,Barry Jacqueline⁴,Bietrix Florence⁶,Blair Nicholas⁷,Braybrook Julian⁸,Campbell Jonathan⁸,Canham Maurice⁹,Chandra Amit¹,Foldes Gabor¹⁰,Gilmanshin Rudy¹¹,Girard Mathilde¹²,Gorjup Erwin¹³,Hewitt Zöe¹⁴,Hourd Paul¹,Hyllner Johan⁴,Jesson Helen¹,Kee Jasmin¹⁵,Kerby Julie¹⁶,Kotsopoulou Nina¹⁷,Kowalski Stanley¹¹,Leidel Chris¹¹,Marshall Damian⁴,Masi Louis¹¹,McCall Mark¹,McCann Conor¹⁸,Medcalf Nicholas¹,Moore Harry¹⁴,Ozawa Hiroki¹⁹,Pan David²⁰,Parmar Malin²¹,Plant Anne L²²,Reinwald Yvonne²³,Sebastian Sujith¹,Stacey Glyn²⁴,Thomas Robert J¹,Thomas Dave²⁵,Thurman-Newell Jamie¹,Turner Marc²⁶,Vitillo Loriana⁷,Wall Ivan²⁷,Wilson Alison²⁸,Wolfrum Jacqueline²⁹,Yang Ying²³,Zimmerman Heiko³⁰

Affiliation:

1. Loughborough University, Centre for Biological Engineering, Holywell Park, Loughborough LE11 3TU, UK

2. Two BC, Newmarket, UK

3. University of Manchester, Michael Smith Building, Oxford Road, Manchester, M13 9PT, UK

4. Cell & Gene Therapy Catapult, 12th Floor Tower Wing, Guy's Hospital, Great Maze Pond, London, SE1 9RT, UK

5. University of Cambridge, John van Geest Centre for Brain Repair, E.D. Adrian Building, Forvie Site, Robinson Way, Cambridge, CB2 0PY, UK

6. European Infrastructure for Translational Medicine, EATRIS Headquarters, De Boelelaan 1118, 1081 HZ Amsterdam, The Netherlands

7. University of Cambridge, Anne McLaren Laboratory for Regenerative Medicine West Forvie Building, Robinson Way, Cambridge, CB2 0SZ, UK

8. LGC Group, Queens Road, Teddington, Middlesex, TW11 0LY, UK

9. University of Edinburgh, MRC Centre for Regenerative Medicine, Edinburgh Bioquarter, 5 Little France Drive, Edinburgh, EH16 4UU, UK

10. Imperial College London, Faculty of Medicine, National Heart & Lung Institute, ICTEM building, Hammersmith Campus, Du Cane Road, London, W12 0NN, UK

11. FloDesign Sonics Inc., 380 Main St, Wilbraham, MA 01095, USA

12. I-Stem, CECS/I-STEM, 2, Rue Henri Desbruères, 91100 Corbeil-Essonnes, France

13. Fraunhofer IBMT, Außenstelle Cambridge/Babraham, Meditrina Building, Babraham Research Campus, Cambridge, CB22 3AT, UK

14. University of Sheffield, Centre for Stem Cell Biology, Alfred Denny Building, Western Bank, Sheffield S10 2TN, UK

15. Reneuron, Pencoed Business Park, Pencoed, Bridgend CF35 5HY, UK

16. Neusentis (Pfizer Ltd.), The Portway Building, Granta Park, Great Abington, Cambridge CB21 6GS, UK

17. Autolus Limited, Forest House, 58 Wood Lane, White City, London, W12 7RP, UK

18. University College London, Stem Cells & Regenerative Medicine Section, UCL Institute of Child Health, 30 Guilford Street, London, WC1N 1EH, UK

19. University College London, UCL Cancer Institute, Paul O'Gorman Building, 72 Huntley Street, London, WC1E 6DD, UK

20. Medical Research Council, 2nd Floor David Phillips Building, Polaris House, North Star Avenue, Swindon, SN2 1FL, UK

21. Lund University, Developmental & Regenerative Neurobiology, Wallenberg Neuroscience Centre, Lund University, 221 84 Lund, Sweden

22. NIST, Material Measurement Laboratory, NIST, Gaithersburg, MD 20899, USA

23. Keele University, Institute for Science & Technology in Medicine, Keele University Thronburrow Drive, Hartshill Stoke-on-Trent, Staffordshire, ST4 7QB, UK

24. National Institute for Biological Standards & Control, Blanche Lane, South Mimms, Potters Bar, Hertfordshire, EN6 3QG, UK

25. TAP Biosystems, Sartorius Stedim, York Way, Royston, Hertfordshire, SG8 5WY UK

26. Scottish National Blood Transfusion Services, SNBTS HeadQuarters, 21 Ellen's Glen Road, Edinburgh, EH17 7QT, UK

27. University College London, Department of Biochemical Engineering, Torrington Place, London, WC1E 7JE, UK

28. CellData Services, 3 Burgate Court, York, YO43 4TZ, UK

29. MIT Center for Biomedical Innovation, Building E19-604, Massachusetts Institute of Technology, Cambridge, MA 02139, USA

30. Fraunhofer IBMT, Fraunhofer-Institut für Biomedizinische Technik IBMT, Joseph-von-Fraunhofer-Weg 1, 66280 Sulzbach, Germany

Abstract

This paper summarizes the proceedings of a workshop held at Trinity Hall, Cambridge to discuss comparability and includes additional information and references to related information added subsequently to the workshop. Comparability is the need to demonstrate equivalence of product after a process change; a recent publication states that this ‘may be difficult for cell-based medicinal products’. Therefore a well-managed change process is required which needs access to good science and regulatory advice and developers are encouraged to seek help early. The workshop shared current thinking and best practice and allowed the definition of key research questions. The intent of this report is to summarize the key issues and the consensus reached on each of these by the expert delegates.

Publisher

Future Medicine Ltd

Subject

Embryology,Biomedical Engineering

Link

https://www.futuremedicine.com/doi/pdf/10.2217/rme-2016-0053

Reference19 articles.

1. ICH Harmonised Tripartitite Guideline, Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process, Q5E, Current Step 4 version, dated 18 November 2004. www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q5E/Step4/Q5E_Guideline.pdf.

2. Europeans Medicines Agency, Comparability of biotechnology products, clinical and non-clinical issues, EMEA/CHMP/BMWP/101695/2006. www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003935.pdf.

3. Manufacturing, characterization and control of cell-based medicinal products: challenging paradigms toward commercial use

4. Hourd P, Chandra A, Sebastian S, Thomas R, Stacey G, Medcalf N, Williams D. Comparability: Manufacturing, Characterisation and Controls Workshop, Version 4.7, Briefing Paper. www.ukrmp.org.uk/hubs/pscp/pscp-workshops/trinity-hall-comparability-workshop/.

5. UK Regenerative Medicine Platform. Trinity Hall Comparability Workshop. www.ukrmp.org.uk/hubs/pscp/pscp-workshops/trinity-hall-comparability-workshop/.

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