Your browser doesn't support javascript.
loading
Comparability: manufacturing, characterization and controls, report of a UK Regenerative Medicine Platform Pluripotent Stem Cell Platform Workshop, Trinity Hall, Cambridge, 14-15 September 2015.
Williams, David J; Archer, Richard; Archibald, Peter; Bantounas, Ioannis; Baptista, Ricardo; Barker, Roger; Barry, Jacqueline; Bietrix, Florence; Blair, Nicholas; Braybrook, Julian; Campbell, Jonathan; Canham, Maurice; Chandra, Amit; Foldes, Gabor; Gilmanshin, Rudy; Girard, Mathilde; Gorjup, Erwin; Hewitt, Zöe; Hourd, Paul; Hyllner, Johan; Jesson, Helen; Kee, Jasmin; Kerby, Julie; Kotsopoulou, Nina; Kowalski, Stanley; Leidel, Chris; Marshall, Damian; Masi, Louis; McCall, Mark; McCann, Conor; Medcalf, Nicholas; Moore, Harry; Ozawa, Hiroki; Pan, David; Parmar, Malin; Plant, Anne L; Reinwald, Yvonne; Sebastian, Sujith; Stacey, Glyn; Thomas, Robert J; Thomas, Dave; Thurman-Newell, Jamie; Turner, Marc; Vitillo, Loriana; Wall, Ivan; Wilson, Alison; Wolfrum, Jacqueline; Yang, Ying; Zimmerman, Heiko.
Affiliation
  • Williams DJ; Loughborough University, Centre for Biological Engineering, Holywell Park, Loughborough LE11 3TU, UK.
  • Archer R; Two BC, Newmarket, UK.
  • Archibald P; Loughborough University, Centre for Biological Engineering, Holywell Park, Loughborough LE11 3TU, UK.
  • Bantounas I; University of Manchester, Michael Smith Building, Oxford Road, Manchester, M13 9PT, UK.
  • Baptista R; Cell & Gene Therapy Catapult, 12th Floor Tower Wing, Guy's Hospital, Great Maze Pond, London, SE1 9RT, UK.
  • Barker R; University of Cambridge, John van Geest Centre for Brain Repair, E.D. Adrian Building, Forvie Site, Robinson Way, Cambridge, CB2 0PY, UK.
  • Barry J; Cell & Gene Therapy Catapult, 12th Floor Tower Wing, Guy's Hospital, Great Maze Pond, London, SE1 9RT, UK.
  • Bietrix F; European Infrastructure for Translational Medicine, EATRIS Headquarters, De Boelelaan 1118, 1081 HZ Amsterdam, The Netherlands.
  • Blair N; University of Cambridge, Anne McLaren Laboratory for Regenerative Medicine West Forvie Building, Robinson Way, Cambridge, CB2 0SZ, UK.
  • Braybrook J; LGC Group, Queens Road, Teddington, Middlesex, TW11 0LY, UK.
  • Campbell J; LGC Group, Queens Road, Teddington, Middlesex, TW11 0LY, UK.
  • Canham M; University of Edinburgh, MRC Centre for Regenerative Medicine, Edinburgh Bioquarter, 5 Little France Drive, Edinburgh, EH16 4UU, UK.
  • Chandra A; Loughborough University, Centre for Biological Engineering, Holywell Park, Loughborough LE11 3TU, UK.
  • Foldes G; Imperial College London, Faculty of Medicine, National Heart & Lung Institute, ICTEM building, Hammersmith Campus, Du Cane Road, London, W12 0NN, UK.
  • Gilmanshin R; FloDesign Sonics Inc., 380 Main St, Wilbraham, MA 01095, USA.
  • Girard M; I-Stem, CECS/I-STEM, 2, Rue Henri Desbruères, 91100 Corbeil-Essonnes, France.
  • Gorjup E; Fraunhofer IBMT, Außenstelle Cambridge/Babraham, Meditrina Building, Babraham Research Campus, Cambridge, CB22 3AT, UK.
  • Hewitt Z; University of Sheffield, Centre for Stem Cell Biology, Alfred Denny Building, Western Bank, Sheffield S10 2TN, UK.
  • Hourd P; Loughborough University, Centre for Biological Engineering, Holywell Park, Loughborough LE11 3TU, UK.
  • Hyllner J; Cell & Gene Therapy Catapult, 12th Floor Tower Wing, Guy's Hospital, Great Maze Pond, London, SE1 9RT, UK.
  • Jesson H; Loughborough University, Centre for Biological Engineering, Holywell Park, Loughborough LE11 3TU, UK.
  • Kee J; Reneuron, Pencoed Business Park, Pencoed, Bridgend CF35 5HY, UK.
  • Kerby J; Neusentis (Pfizer Ltd.), The Portway Building, Granta Park, Great Abington, Cambridge CB21 6GS, UK.
  • Kotsopoulou N; Autolus Limited, Forest House, 58 Wood Lane, White City, London, W12 7RP, UK.
  • Kowalski S; FloDesign Sonics Inc., 380 Main St, Wilbraham, MA 01095, USA.
  • Leidel C; FloDesign Sonics Inc., 380 Main St, Wilbraham, MA 01095, USA.
  • Marshall D; Cell & Gene Therapy Catapult, 12th Floor Tower Wing, Guy's Hospital, Great Maze Pond, London, SE1 9RT, UK.
  • Masi L; FloDesign Sonics Inc., 380 Main St, Wilbraham, MA 01095, USA.
  • McCall M; Loughborough University, Centre for Biological Engineering, Holywell Park, Loughborough LE11 3TU, UK.
  • McCann C; University College London, Stem Cells & Regenerative Medicine Section, UCL Institute of Child Health, 30 Guilford Street, London, WC1N 1EH, UK.
  • Medcalf N; Loughborough University, Centre for Biological Engineering, Holywell Park, Loughborough LE11 3TU, UK.
  • Moore H; University of Sheffield, Centre for Stem Cell Biology, Alfred Denny Building, Western Bank, Sheffield S10 2TN, UK.
  • Ozawa H; University College London, UCL Cancer Institute, Paul O'Gorman Building, 72 Huntley Street, London, WC1E 6DD, UK.
  • Pan D; Medical Research Council, 2nd Floor David Phillips Building, Polaris House, North Star Avenue, Swindon, SN2 1FL, UK.
  • Parmar M; Lund University, Developmental & Regenerative Neurobiology, Wallenberg Neuroscience Centre, Lund University, 221 84 Lund, Sweden.
  • Plant AL; NIST, Material Measurement Laboratory, NIST, Gaithersburg, MD 20899, USA.
  • Reinwald Y; Keele University, Institute for Science & Technology in Medicine, Keele University Thronburrow Drive, Hartshill Stoke-on-Trent, Staffordshire, ST4 7QB, UK.
  • Sebastian S; Loughborough University, Centre for Biological Engineering, Holywell Park, Loughborough LE11 3TU, UK.
  • Stacey G; National Institute for Biological Standards & Control, Blanche Lane, South Mimms, Potters Bar, Hertfordshire, EN6 3QG, UK.
  • Thomas RJ; Loughborough University, Centre for Biological Engineering, Holywell Park, Loughborough LE11 3TU, UK.
  • Thomas D; TAP Biosystems, Sartorius Stedim, York Way, Royston, Hertfordshire, SG8 5WY UK.
  • Thurman-Newell J; Loughborough University, Centre for Biological Engineering, Holywell Park, Loughborough LE11 3TU, UK.
  • Turner M; Scottish National Blood Transfusion Services, SNBTS HeadQuarters, 21 Ellen's Glen Road, Edinburgh, EH17 7QT, UK.
  • Vitillo L; University of Cambridge, Anne McLaren Laboratory for Regenerative Medicine West Forvie Building, Robinson Way, Cambridge, CB2 0SZ, UK.
  • Wall I; University College London, Department of Biochemical Engineering, Torrington Place, London, WC1E 7JE, UK.
  • Wilson A; CellData Services, 3 Burgate Court, York, YO43 4TZ, UK.
  • Wolfrum J; MIT Center for Biomedical Innovation, Building E19-604, Massachusetts Institute of Technology, Cambridge, MA 02139, USA.
  • Yang Y; Keele University, Institute for Science & Technology in Medicine, Keele University Thronburrow Drive, Hartshill Stoke-on-Trent, Staffordshire, ST4 7QB, UK.
  • Zimmerman H; Fraunhofer IBMT, Fraunhofer-Institut für Biomedizinische Technik IBMT, Joseph-von-Fraunhofer-Weg 1, 66280 Sulzbach, Germany.
Regen Med ; 11(5): 483-92, 2016 Jul.
Article in En | MEDLINE | ID: mdl-27404768
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.
Subject(s)
Key words
Fulltext
Print
XML
PubMed Links
Search on Google

Full text: 1 Database: MEDLINE Main subject: Pluripotent Stem Cells / Regenerative Medicine Type of study: Guideline / Prognostic_studies Limits: Humans Country/Region as subject: Europa Language: En Year: 2016 Type: Article
Fulltext
Print
XML
PubMed Links
Search on Google

Full text: 1 Database: MEDLINE Main subject: Pluripotent Stem Cells / Regenerative Medicine Type of study: Guideline / Prognostic_studies Limits: Humans Country/Region as subject: Europa Language: En Year: 2016 Type: Article