References
- McKernon R , McNeishJ , SmithD . Pharma’s developing interest in stem cells . Cell Stem Cell6 ( 6 ), 517 – 520 ( 2010 ).
- Maciulaitis R , D’ApoteL , BuchananA , PioppoL , SchneiderCK . Clinical development of advanced therapy medicinal products in europe: Evidence that regulators must be proactive . Mol. Ther.20 , 479 – 482 ( 2012 ).
- Culme-Seymour EJ , DavieLN , BrindleyDA , Edwards-PartonS , MasonC . A decade of cell therapy clinical trials (2000–2010) . Regen. Med.7 ( 4 ), 455 – 62 ( 2012 ).
- The Cell Therapy Catapult UK Clinical Trials Database as of November 2012 ( 2012 ). www.catapult.org.uk/documents/10726/1553967/CTC+database+commentary/0f818af3–8683–4b08–9815-d7ebdd092d4e .
- Pearce KF , HildebrandtM , GreinixHet al. Regulation of advanced therapy medicinal products in Europe and the role of academia . Cytotherapy16 ( 3 ), 289 – 297 ( 2014 ).
- Sethe S , BatkaiC , DickinsonA , HildebrandM . Manufacture of advanced therapies: Academia meets industry . Regulatory Rapporteur8 ( 7/8 ), 9 – 10 ( 2011 ).
- The ATMP Manufacturing Community Capacity Database: GMP Facilities licensed for ATMP manufacture in the UK as of December 2012 ( 2012 ). www.atmpmanufacture.org/Capacity/Capacity.php .
- Eudralex - Volume 4 Good Manufacturing Practice (GMP) guidelines for medicinal products for human and veterinary use. European Commission . http://ec.europa.eu/health/documents/eudralex/vol-4/ .
- Commission Directive 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 ( 2003 ). http://ec.europa.eu/health/files/eudralex/vol-1/dir_2003_94/dir_2003_94_en.pdf .
- Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 ( 2007 ). http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2007:324:0121:0137:en:PDF .
- Guideline on process validation for finished products - information and data to be provided in regulatory submissions. European Medicines Agency ( 2014 ). www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2014/02/WC500162136.pdf .
- EudraLex - Volume 4 Good Manufacturing Practice (GMP) guidelines for medicinal products for human and veterinary use. Annex 2. Manufacture of biological active substances and medicinal products for human use ( 2013 ). http://ec.europa.eu/health/files/eudralex/vol-4/vol4-an2__2012–06_en.pdf .
- EudraLex - Volume 4 Good Manufacturing Practice (GMP) guidelines for medicinal products for human and veterinary use. Annex 15. Qualification and Validation ( 2014 ). http://ec.europa.eu/health/files/gmp/2014–02_pc_draft_gmp_annex.pdf .
- Regulation (EC) No. 1394/2007 on Advanced Therapy Medicinal Products. Summary of the response to the public consultation. European Commission ( 2013 ). http://ec.europa.eu/health/files/advtherapies/2013_05_pc_atmp/2013_04_03_pc_summary.pdf .
- Report from the Commission to the European Parliament and the Council. European Commission ( 2014 ). http://ec.europa.eu/health/files/advtherapies/2014_atmp/atmp_en.pdf .
- Remedi. building a viable regenerative medicine industry – a guide for stakeholders . WilliamsDJ , ArcherR , DentA ( Eds ) Loughborough University , Loughborough, UK ( 2010 ). www.epsrc.ac.uk/SiteCollectionDocuments/Publications/reports/Remedi.pdf .
- Trounson A , DeWittND , FiegalEG . The alpha stem cell clinic: A model for evaluating and delivering stem cell-based therapies . Stem Cells Transl. Med.1 , 9 – 14 ( 2012 ).
- Williams DJ , ThomasRJ , HourdPCet al. Precision manufacturing for clinical-quality regenerative medicines . Phil. Trans. R. Soc. A.370 , 3924 – 3949 ( 2012 ).
- Pharmaceutical Engineering Guides for New and Renovated Facilities (Volume 5) - Commissioning and Qualification. International Society of Pharmaceutical Engineering ( 2001 ).
- Glo germ . www.glogerm.com .
- Oberyszyn A , RobertsonF . Novel rapid method for visualisation of extent and location of aerosol contamination during high-speed sorting of potentially biohazardous samples . Cytometry43 , 217 – 222 ( 2001 ).
- Perfetto S , AmbrozakD , KoupR , RoedererM . Measuring containment of viable infectious cell sorting in high-velocity cell sorters . Cytometry52 ( 2 ), 122 – 130 ( 2003 ).
- Mestrandrea L . Microbiological considerations for non-sterile pharmaceuticals ( 2012 ). www.interphex.com/RNA/RNA_interphex_V2/documents/2012/speaker_presentations/LenMestrandrea.pdf?v=z634722777526434350 .
- Guidance for Industry . Process Validation: General Principles and Practices US FDA ( 2011 ). www.fda.gov/downloads/Drugs/Guidances/UCM070336.pdf .
- Hourd PC , GintyP , ChandraA , WilliamsDJ . Manufacturing models permitting roll out/scale out of clinically-led autologous cell therapies: Regulatory and scientific challenges for comparability . Cytotherapy16 ( 8 ), 1033 – 1047 ( 2014 ).