Archives

  • 2018-07
  • 2018-10
  • 2018-11
  • 2019-04
  • 2019-05
  • Our facility was not licensed

    2018-10-20

    Our facility was not licensed by the US FDA for the manufacture of biologics to US guidelines standards for current Good Tissue Practice. However, our interpretation of these guidelines and standards (Table 2) is that they do not differ substantially from the requirements of EC directives and of HFEA and HTA licensure. There are some differences between EU and US in terms of administration and specification of GMP. Technical specifications can also vary, such as for ambient environment classification (i.e. comparison of Eudralex Vol 4, Annex I vs FDA Aseptic processing guide for GMP). However, irrespective of such nuances, either standard provides the highest level of traceability, control and quality assurance, and aspiring to comply with either can provide a higher level of assurance of source material than otherwise is mandated by both jurisdictions currently. It is our understanding based on the analysis in Table 2 that the cell lines prepared at Roslin Cells will be suitable for onward processing in the USA. However, this will require to be tested by consultation and discussion with the US FDA. Lastly, guidelines prepared by the International Society for Stem Cell Research (ISSCR) (2006, 2008, 2016) for global standards of conduct of Human Embryonic Stem Cell Research and clinical m1v1 m2v2 calculator originally published in 2006 and 2008 (respectively) were recently updated (see Commentary, Daley et al., 2016). Our review of these confirms compliance of all hESC lines created in our programme with applicable standards (Supplementary Fig. 7).
    Author contributions
    Competing interests
    Acknowledgements The authors gratefully acknowledge the leadership and commitment of Mr Aidan Courtney as co-founder and chief executive officer (2005–2016), as well as the voluntary commitment of expertise, time and effort of past and current executive and non-executive directors and observers on the Roslin Cells board of governors. This includes Prof. Charles ffrench-Constant, Dr Andrew Henderson, and Dr Wendy Nicholson as non-executive directors; Mr Paul Williams as Finance Director; Dr Ed Hutchinson, Dr John Campbell, and Mr Bruce Gellatly as observers. The project would not have been possible without the generous voluntary donation of embryos from donors undergoing assisted conception and the staff in HFEA licensed centres in the United Kingdom involved in ethical provision of patient information and consent and embryo procurement at; University College Hospital in London (UCH, centre no. 044), St Mary\'s Hospital in Manchester (SMH, 067), Aberdeen Fertility Centre (AFC, 019), Nine Wells Hospital in Dundee (NW, 004), and Edinburgh Assisted Conception Unit at the Royal Infirmary (EAC, 201). At these centres the authors are particularly grateful for guidance, management, nursing and clinical embryology provided by: Prof. Joy Delhanty (044); Dr. Alpesh Doshi, Profs. Daniel Brison and Sue Kimber, and Dr Sharon Sneddon (067); Prof. Siladtya Battycharya and Maureen Wood (019); Prof. Chris Barratt (004); and Drs Joo Thong and Sue Pickering (201). The authors acknowledge the effort and commitment of Roslin Cells Ltd staff involved in research & development, quality control, quality assurance and production culminating in QA GMP hESC derivation and banking, the identity of which accompany resource details reported in De Sousa et al. (2016a, b, c, d, e, f, g, h, i, j, k, l, m, n, o, p), notably; John Gardner, Daniel Collins, Helen Bradburn, Gregor Russel, Anne Greenshields, Kelly McDonald, Audrey Laurie and Deborah Allan. The authors thank and acknowledge the guidance and support of senior management and operational staff at the SNBTS supporting the establishment of Roslin Cells Quality Management System and the design, installation, operation, and performance qualification of the QA GMP facility, notably Drs Bruce Cuthbertson and John Drain. Lastly, the authors are grateful for past and ongoing administrative support provided by Mrs. Kathyrn Reilly, Suzy Purcel, Sharen McShane, and Frances Burgess. Roslin Cells was founded and operated with core funding from the Scottish Enterprise Economic Development Agency in a grant to PDS, MB and AC (No. PM07321, 2006-2011). The authors also acknowledge funding to MT, PDS, AC and others from the Wellcome Trust (No. 130810, 2009–2011) in support of QA GMP hESC production in support of blood cell production.