Manufacturing and quality control of cell-based tumor vaccines: A scientific and a regulatory perspective

Journal of Immunotherapy

Volumn 29, Issue 5, 2006, Pages 472-476

  Hinz, Thomas ^a   Buchholz, Christian J ^a   Van Der Stappen, Ton ^b   Cichutek, Klaus ^a   Kalinke, Ulrich ^a  

^a PAUL EHRLICH INSTITUT   (Germany)

^b NATIONAL INSTITUTE FOR PUBLIC HEALTH AND THE ENVIRONMENT   (Netherlands)

Author keywords

Cancer vaccine; Potency; Regulatory guidance document

Indexed keywords

TUMOR VACCINE;

ADOPTIVE IMMUNOTHERAPY; DRUG POTENCY; ENZYME LINKED IMMUNOSPOT ASSAY; GENE TRANSFER; HUMAN; IMMUNIZATION; NONHUMAN; PRIORITY JOURNAL; REVIEW; SOMATIC GENE THERAPY; STANDARDIZATION;

CANCER VACCINES; DENDRITIC CELLS; DRUG INDUSTRY; EUROPEAN UNION; HUMANS; IMMUNOTHERAPY, ADOPTIVE; QUALITY CONTROL; T-LYMPHOCYTES;

EID: 33748701440     PISSN: 15249557     EISSN: None     Source Type: Journal    
DOI: 10.1097/01.cji.0000211305.98244.56     Document Type: Review

References (35)

1. Dudley ME, Wunderlich JR, Robbins PF, et al. Cancer regression and autoimmunity in patients after clonal repopulation with antitumor lymphocytes. Science. 2002;298:850-854.
2. Dudley ME, Wunderlich JR, Yang JC, et al. Adoptive cell transfer therapy following non-myeloablative but lymphodepleting chemotherapy for the treatment of patients with refractory metastatic melanoma. J Clin Oncol. 2005;23:2346-2357.
3. Mitchell MS, Kan-Mitchell J, Kempf RA, et al. Active specific immunotherapy for melanoma: phase I trial of allogeneic lysates and a novel adjuvant. Cancer Res. 1988;48:5883-5893.
4. Morton DL, Hsueh EC, Essner R, et al. Prolonged survival of patients receiving active immunotherapy with Canvaxin therapeutic polyvalent vaccine after complete resection of melanoma metastatic to regional lymph nodes. Ann Surg. 2002;236:438-448.
5. Dranoff G. GM-CSF-secreting melanoma vaccines. Oncogene. 2003;22:3188-3192.
6. Ward S, Casey D, Labarthe MC, et al. Immunotherapeutic potential of whole tumour cells. Cancer Immunol Immunother. 2002;51:351-357.
7. Banchereau J, Palucka AK. Dendritic cells as therapeutic vaccines against cancer. Nat Rev Immunol. 2005;5:296-306.
8. Figdor CG, de Vries IJ, Lesterhuis WJ, et al. Dendritic cell immunotherapy: mapping the way. Nat Med. 2004;10:475-480.
9. Moingeon P. Cancer vaccines. Vaccine. 2001;19:1305-1326.
10. Renkvist N, Castelli C, Robbins PF, et al. A listing of human tumor antigens recognized by T cells. Cancer Immunol Immunother. 2001;50:3-15.
11. Gong J, Chen D, Kashiwaba M, et al. Induction of antitumor activity by immunization with fusions of dendritic and carcinoma cells. Nat Med. 1997;3:558-561.
12. Rosenberg SA, Yang JC, Restifo NP. Cancer immunotherapy: moving beyond current vaccines. Nat Med. 2004;10:909-915.
13. Phan GQ, Yang JC, Sherry RM, et al. Cancer regression and autoimmunity induced by cytotoxic T lymphocyte-associated antigen 4 blockade in patients with metastatic melanoma. Proc Natl Acad Sci U S A. 2003;100:8372-8377.
14. Poehlein CH, Ruttinger D, Ma J, et al. Immunotherapy for melanoma: the good, the bad, and the future. Curr Oncol Rep. 2005;7:383-392.
15. Commission Directive 2003/63/EC, of 25 June 2003 amending Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use. Official Journal No. L159/46 of 27.6.2003.
16. Note for guidance on the quality, preclinical and clinical aspects of gene transfer medicinal products. CPMP/BWP/3088/99.
17. 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. 17-7-1991. Official Journal No. L 193 of 17.7.91.
18. Directive 2001/20/EC of the European Parliament and the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. 1-5-2001. Official Journal No. L121/34 of 1 May 2001.
19. European Commission: EudraLex-The Rules Governing Medicinal Products in the European Union. Vol. 4. Good manufacturing practices. Annex 13. Manufacture of investigational medicinal products. July 2003. Available at: http://pharmacos.eudra.org/F2/eudralex/vol-4/pdfs-en/An13final_24-02-05.pdf. Accessed February 6, 2006.
20. ICH Topic Q 5 D. Quality of Biotechnological Products: Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/ Biological Products. CPMP/ICH/294/95.
21. Points to consider on the manufacture and quality control of human somatic cell therapy medicinal products. CPMP/BWP/41450/98.
22. ICH Topic Q 6 B. Specifications: Test procedures and acceptance criteria for biotechnological/biological products. CPMP/ICH/365/96.
23. Sallusto F, Lanzavecchia A. Efficient presentation of soluble antigen by cultured human dendritic cells is maintained by granulocyte/macrophage colony-stimulating factor plus interleukin 4 and downregulated by tumor necrosis factor alpha. J Exp Med. 1994;179:1109-1118.
24. Wolfel T, Van Pel A, Brichard V, et al. Two tyrosinase nonapeptides recognized on HLA-A2 melanomas by autologous cytolytic T lymphocytes. Eur J Immunol. 1994;24:759-764.
25. Newton PJ, Weller IV, Katz DR, et al. Autologous apoptotic T cells interact with dendritic cells, but do not affect their surface phenotype or their ability to induce recall immune responses. Clin Exp Immunol. 2003;133:50-58.
26. Shankar G, Bader R, Lodge PA. The COSTIM bioassay: a novel potency test for dendritic cells. J Immunol Methods. 2004;285:293-299.
27. Berard F, Blanco P, Davoust J, et al. Cross-priming of naive CD8 T cells against melanoma antigens using dendritic cells loaded with killed allogeneic melanoma cells. J Exp Med. 2000;192:1535-1544.
28. Vertuani S, Sette A, Sidney J, et al. Improved immunogenicity of an immunodominant epitope of the HER-2/neu protooncogene by alterations of MHC contact residues. J Immunol. 2004;172:3501-3508.
29. Drexler I, Antunes E, Schmitz M, et al. Modified vaccinia virus Ankara for delivery of human tyrosinase as melanoma-associated antigen: induction of tyrosinase- and melanoma-specific human leukocyte antigen A*0201- restricted cytotoxic T cells in vitro and in vivo. Cancer Res. 1999;59:4955-4966.
30. Palmowski MJ, Lopes L, Ikeda Y, et al. Intravenous injection of a lentiviral vector encoding NY-ESO-1 induces an effective CTL response. J Immunol. 2004;172:1582-1587.
31. Bernhard EJ, Le AX, Barbosa JA, et al. Cytotoxic T lymphocytes from HLA-A2 transgenic mice specific for HLA-A2 expressed on human cells. J Exp Med. 1988;168:1157-1162.
32. Ribas A, Butterfield LH, Glaspy JA, et al. Cancer immunotherapy using gene-modified dendritic cells. Curr Gene Ther. 2002;2:57-78.
33. Razzaque A, Dye E, Puri RK. Characterization of tumor vaccines during product development. Vaccine. 2000;19:644-647.
34. Keegan, Essayan, Puri, et al. Regulatory considerations in tumour vaccine development. In: Petricciani J, Brown F, eds. Development of Therapeutic Cancer Vaccines. Basel, Switzerland: Karger AG; 2004:69-76.
35. Cancer Vaccine Consortium - potency testing workshop. Biologicals. 2005;33:123-128.