First update of the International Xenotransplantation Association consensus statement on conditions for undertaking clinical trials of porcine islet products in type 1 diabetes - Chapter 3: Porcine islet product manufacturing and release testing criteria

Xenotransplantation

Volumn 23, Issue 1, 2016, Pages 38-45

  Rayat, Gina R ^a   Gazda, Lawrence S ^b   Hawthorne, Wayne J ^c   Hering, Bernhard J ^d   Hosking, Peter ^e   Matsumoto, Shinichi ^f   Rajotte, Ray V ^a  

^a UNIVERSITY OF ALBERTA   (Canada)

^b ROGOSIN INSTITUTE   (United States)

^c UNIVERSITY OF SYDNEY   (Australia)

^d UNIVERSITY OF MINNESOTA   (United States)

^e Diatranz Otsuka Limited   (New Zealand)

^f OTSUKA PHARMACEUTICAL CO LTD   (Japan)

Author keywords

good manufacturing practices; porcine islets of langerhans; type 1 diabetes; xenotransplantation

Indexed keywords

BIOLOGICAL PRODUCT;

ARTICLE; CELL COUNT; CELL STRUCTURE; CELL VIABILITY; CONSENSUS; CONTROLLED STUDY; FOOD AND DRUG ADMINISTRATION; GOOD MANUFACTURING PRACTICE; HUMAN; INSULIN DEPENDENT DIABETES MELLITUS; PANCREAS; PANCREAS ISLET BETA CELL; PHASE 1 CLINICAL TRIAL; PHASE 2 CLINICAL TRIAL; PIG; PRIORITY JOURNAL; PUBLIC HEALTH SERVICE; QUALITY CONTROL; REPRODUCIBILITY; SAFETY; SOMATIC CELL THERAPY; XENOTRANSPLANTATION; ANIMAL; CLINICAL TRIAL (TOPIC); CONSENSUS DEVELOPMENT; DIABETES MELLITUS, TYPE 1; INFORMED CONSENT; LEGISLATION AND JURISPRUDENCE; PANCREAS ISLET TRANSPLANTATION; PATIENT SELECTION; PROCEDURES; XENOGRAFT;

ANIMALS; CLINICAL TRIALS AS TOPIC; DIABETES MELLITUS, TYPE 1; HUMANS; INFORMED CONSENT; ISLETS OF LANGERHANS TRANSPLANTATION; PATIENT SELECTION; QUALITY CONTROL; SWINE; TRANSPLANTATION, HETEROLOGOUS;

EID: 84960806093     PISSN: 0908665X     EISSN: 13993089     Source Type: Journal    
DOI: 10.1111/xen.12225     Document Type: Article

References (25)

1. Korbutt GS,. The International Xenotransplantation Association consensus statement on conditions for undertaking clinical trials of porcine islet products in type 1 diabetes-chapter 3: Pig islet product manufacturing and release testing. Xenotransplantation 2009; 16: 223-228.
2. U.S. Food and Drug Administration. Guidance for Industry Source Animal, Product, Preclinical, and Clinical Issues Concerning the Use of Xenotransplantation Products in Humans. 2003. Available at: Http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceCompliance RegulatoryInformation/Guidances/CellularandGeneTherapy/UCM166165.pdf [accessed on 08 September 2014].
3. U.S. Food and Drug Administration. Application of Current Statutory Authorities to Human Somatic Cell Therapy Products and Gene Therapy Products: Notice 1993 58 FR 53248. 1993. Available at: Http://www.fda.gov/downloads/BiologicsBloodVaccines/SafetyAvailability/UCM148113.pdf [accessed on 08 September 2014].
4. International Conference on Harmonization Guidelines. Q6B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products. 1999. Available at: Http://www.ich.org/fileadmin/Public-Web-Site/ICH-Products/Guidelines/Quality/Q6B/Step4/Q6B-Guideline.pdf [accessed on 10 September 29, 2014].
5. International Conference on Harmonization Guidelines. Q5D Quality of Biotechnological/Biological Products: Derivation, Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products. 1997. Available at: Http://www.ich.org/fileadmin/Public-Web-Site/ICH-Products/Guidelines/Quality/Q5D/Step4/Q5D-Guideline.pdf [accessed on 10 September 2014].
6. International Conference on Harmonisation Guidelines. Q5A (R1) Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin. 1999. Available at: Http://www.ich.org/fileadmin/Public-Web-Site/ICH-Products/Guidelines/Quality/Q5A-R1/Step4/Q5A-R1--Guideline.pdf [accessed on 14 September 2014].
7. U.S. Food and Drug Administration. Public Health Service Act Title 42-The Public and Welfare Chapter 6A-Public Health Service. 1999. Available at: Http://www.fda.gov/RegulatoryInformation/Legislation/ucm149278.htm [accessed on September 14, 2014].
8. U.S. Federal Food and Drug Administration. Food, Drug, and Cosmetic Act, Chapter 5-Drugs and Devices. 2010. Available at: Http://www.gpo.gov/fdsys/pkg/USCODE-2010-title21/pdf/USCODE-2010-title21-chap9-subchapV-partA-sec355.pdf [accessed on September 15, 2014].
9. U.S. Food and Drug Administration. Guidance for Industry: Guidance for Human Somatic Cell Therapy and Gene Therapy. 2008. Available at: Http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/CellularandGeneTherapy/ucm081670.pdf [accessed on 15 September 2014].
10. U.S. Food and Drug Administration. Guidance for Industry: Content and Format of Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-derived Products. 2008. Available at: Http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceCompliance RegulatoryInformation/Guidances/CellularandGeneTherapy/UCM166165.pdf [accessed on 15 September 2014].
11. U.S. Food and Drug Administration. Guidance for Industry: CGMP for Phase 1 Investigational Drugs. 2008. Available at: Http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm070273.pdf [accessed on September 19, 2014].
12. Investigational Drugs Pharmaceutical Inspection Co-operation Scheme. Guide to Good Manufacturing Practice for Medicinal Products Part 1. 2014. Available at: Http://www.picscheme.org/publication.php?id=4 [accessed on September 21, 2014].
13. Second WHO Global Consultation on Regulatory Requirements for Xenotransplantation Clinical Trials: Geneva, Switzerland, 17-19 October 2011.
14. Gazda LS, Adkins H, Bailie JA, et al., The use of biopsy provides reliable porcine islet yields while encapsulation permits the determination of microbiological safety. Cell Transplant 2005; 14: 427-439.
15. Loganathan G, Graham ML, Spizzo T, et al., Pretreatment of donor pigs with a diet rich in soybean oil increases the yield of isolated islets. Transplant Proc 2014; 46: 1945-1949.
16. Anazawa T, Balamurugan AN, Matsumoto S, et al., Rapid quantitative assessment of the pig pancreas biopsy predicts islet yield. Transplant Proc 2010; 42: 2036-2039.
17. Costa RM, Fischer N, Gulich B, Tönjes RR,. Comparison of porcine endogenous retroviruses infectious potential in supernatants of producer cells and in cocultures. Xenotransplantation 2014; 21: 162-173.
18. Kolstoe EM, Iverseen T, Ostensvik O, et al., Specific pathogen-free pig herds also free from Compylobacter? Zoonoses Public Health 2015; 62: 125-130.
19. Jim SM, Shin JS, Kim KS, et al., Islet isolation from adult pig designated pathogen-free pigs: Use of the newer bovine nervous tissue-free enzymes and a revised donor selection strategy would improve the islet graft function. Xenotransplantation 2011; 18: 369-379.
20. Wynyard S, Nathu D, Garkavenko O, Denner J, Elliott R,. Microbiological safety of the first clinical pig islets xenotransplantation trial in New Zealand. Xenotransplantation 2014; 21: 309-314.
21. Denner J, Schuurman HJ, Patience C,. The International Xenotransplantation Association consensus statement on conditions for undertaking clinical trials of porcine islet products in type 1 diabetes-chapter 5: Strategies to prevent transmission of porcine endogenous retroviruses. Xenotransplantation 2009; 16: 239-248.
22. European Medicines Agency. Committee for Medicinal Products for Human Use: Guideline on Xenogeneic Cell-Based Medicinal Products. 2009. Available at: Http://www.ema.europa.eu/docs/en-GB/document-library/Scientific-guideline/2009/12/WC500016936.pdf [accessed on 18 July 2014].
23. Kobayashi T, Arefanian H, Harb G, et al., Prolonged survival of microencapsulated neonatal porcine islet xenografts in immune-competent mice without antirejection therapy. Cell Transplant 2008; 17: 1243-1256.
24. Kasibhatla S, Amarante Mendes GP, Finucane D, et al., Acridine orange/ethidium bromide (AO/EB): Staining to detect apoptosis. Cold Spring Harb Protoc 2006; 2006: Pii: Pdb.prot4493.
25. https://www.isletstudy.org/: Test Release Method SOPs: Qualitative and Quantitative Assessment of Islets.