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  • Williams, David J.Loughborough University (author)

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

  • Article/chapterEnglish2016

Publisher, publication year, extent ...

  • Future Medicine Ltd,2016
  • 10 s.

Numbers

  • LIBRIS-ID:oai:lup.lub.lu.se:cbf3789e-65e8-47c6-928f-60a52f1a923a
  • https://lup.lub.lu.se/record/cbf3789e-65e8-47c6-928f-60a52f1a923aURI
  • https://doi.org/10.2217/rme-2016-0053DOI

Supplementary language notes

  • Language:English
  • Summary in:English

Part of subdatabase

Classification

  • Subject category:art swepub-publicationtype
  • Subject category:ref swepub-contenttype

Notes

  • 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 headings and genre

Added entries (persons, corporate bodies, meetings, titles ...)

  • Archer, RichardTwo BC Ltd (author)
  • Archibald, PeterLoughborough University (author)
  • Bantounas, IoannisUniversity of Manchester (author)
  • Baptista, RicardoGuy's and St Thomas' NHS Foundation Trust (author)
  • Barker, RogerLund University,Lunds universitet,Utvecklings- och regenerativ neurobiologi,Forskargrupper vid Lunds universitet,Developmental and Regenerative Neurobiology,Lund University Research Groups,University of Cambridge(Swepub:lu)med-rob (author)
  • Barry, JacquelineGuy's and St Thomas' NHS Foundation Trust (author)
  • Bietrix, FlorenceEuropean Infrastructure for Translational Medicine (author)
  • Blair, NicholasUniversity of Cambridge (author)
  • Braybrook, JulianLGC Group (author)
  • Campbell, JonathanLGC Group (author)
  • Canham, MauriceUniversity of Edinburgh (author)
  • Chandra, AmitLoughborough University (author)
  • Foldes, GaborImperial College London (author)
  • Gilmanshin, RudyFlodesign Sonics Inc. (author)
  • Girard, MathildeInstitute For Stem Cell Therapy And Exploration Of Monogenic Diseases (CECS/I-Stem) (author)
  • Gorjup, ErwinBabraham Institute (author)
  • Hewitt, ZöeUniversity of Sheffield (author)
  • Hourd, PaulLoughborough University (author)
  • Hyllner, JohanGuy's and St Thomas' NHS Foundation Trust (author)
  • Jesson, HelenLoughborough University (author)
  • Kee, JasminReneuron (author)
  • Kerby, JuliePfizer Inc. US (author)
  • Kotsopoulou, NinaAutolus Ltd (author)
  • Kowalski, StanleyFlodesign Sonics Inc. (author)
  • Leidel, ChrisFlodesign Sonics Inc. (author)
  • Marshall, DamianGuy's and St Thomas' NHS Foundation Trust (author)
  • Masi, LouisFlodesign Sonics Inc. (author)
  • McCall, MarkLoughborough University (author)
  • McCann, ConorUniversity College London (author)
  • Medcalf, NicholasLoughborough University (author)
  • Moore, HarryUniversity of Sheffield (author)
  • Ozawa, HirokiRoyal Free Hospital (author)
  • Pan, DavidMRC Human Nutrition Research (author)
  • Parmar, MalinLund University,Lunds universitet,Wallenberg Neurocentrum, Lund,Medicinska fakulteten,Wallenberg Neuroscience Centre, Lund,Faculty of Medicine(Swepub:lu)mphy-mpa (author)
  • Plant, Anne L.National Institute of Standards and Technology (NIST) (author)
  • Reinwald, YvonneKeele University (author)
  • Sebastian, SujithLoughborough University (author)
  • Stacey, GlynNational Institute for Biological Standards and Control (author)
  • Thomas, Robert J.Loughborough University (author)
  • Thomas, DaveTAP Biosystems (author)
  • Thurman-Newell, JamieLoughborough University (author)
  • Turner, MarcSNBTS HeadQuarters (author)
  • Vitillio, LorianaUniversity of Cambridge (author)
  • Wall, IvanRoyal Free Hospital (author)
  • Wilson, AlisonCellData Services (author)
  • Wolfrum, JacquelineMassachusetts Institute of Technology (author)
  • Yang, YingKeele University (author)
  • Zimmerman, HeikoFraunhofer Institute for Biomedical Engineering (author)
  • Loughborough UniversityTwo BC Ltd (creator_code:org_t)

Related titles

  • In:Regenerative Medicine: Future Medicine Ltd11:5, s. 483-4921746-07511746-076X

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