Gram-scale production of plasmid pUDK-HGF with current good manufacturing practices for gene therapy of critical limb ischemia

References

• Kawamoto, A.; Katayama, M.; Handa, N.; Kinoshita, M.; Takano, H.; Horii, M.; Sadamoto, K.; Yokoyama, A.; Yamanaka, T.; Onodera, R.; Kuroda, A.; Baba, R.; Kaneko, Y.; Tsukie, T.; Kurimoto, Y.; Okada, Y.; Kihara, Y.; Morioka, S.; Fukushima, M.; Asahara, T. Intramuscular Transplantation of G-CSF-mobilized CD34(+) Cells in Patients with Critical Limb Ischemia: A Phase I/IIa, Multicenter, Single-blinded, Dose-escalation Clinical Trial. Stem cells 2009, 27(11), 2857–2864.
   PubMed Web of Science ®Google Scholar
• Selvin, E.; Erlinger, T.P. Prevalence of and Risk Factors for Peripheral Arterial Disease in the United States: Results from the National Health and Nutrition Examination Survey, 1999–2000. Circulation 2004, 110(6), 738–743.
   PubMed Web of Science ®Google Scholar
• Norgren, L.; Hiatt, W.R.; Dormandy, J.A.; Nehler, M.R.; Harris, K.A.; Fowkes, F.G.; Group, T.I.W. Inter-society Consensus for the Management of Peripheral Arterial Disease (TASC II). J. Vasc. Surg. 2007, 45, S5–S67.
   PubMed Web of Science ®Google Scholar
• Hirsch, A.T. Critical Limb Ischemia and Stem Cell Research: Anchoring Hope with Informed Adverse Event Reporting. Circulation 2006, 114(24), 2581–2583.
   PubMed Web of Science ®Google Scholar
• Schanzer, A.; Hevelone, N.; Owens, C.D.; Beckman, J.A.; Belkin, M.; Conte, M.S. Statins are Independently Associated with Reduced Mortality in Patients Undergoing Infrainguinal Bypass Graft Surgery for Critical Limb Ischemia. J. Vasc. Surg. 2008, 47(4), 774–781.
   PubMed Web of Science ®Google Scholar
• Ha, X.Q.; Wang, X.G.; Wu, Z.Z. Study on Construction of a Plasmid Vector Carrying Human Hepatocyte Growth Factor Gene and Activity of its Expression Product. Chin. J. Appl. Physiol. 2002, 18(3), 278–282.
   Google Scholar
• Ha, X.Q.; Li, Y.M.; Bi, J.J.; Zhang, Q.L.; Wu, Z.Z. Plasmid pUDKH Gene Therapy of Rat Acute Hindlimb Ischemia: An Experimental Study. Natl. Med. J. Chin. 2003, 83(17), 1521–1524.
   Google Scholar
• Cui, S.; Guo, L.; Li, X.; Gu, Y.; Fu, J.; Dong, L.; Song, H.; Chen, X.; Lu, Y.; Hu, C.; Xiao, F.; Zhu, D.; Wu, Z.; Zhang, Q. Clinical Safety and Preliminary Efficacy of Plasmid pUDK-HGF Expressing Human Hepatocyte Growth Factor (HGF) in Patients with Critical Limb Ischemia. Eur J. Vasc. Endovasc. Surg. Off. J. Eur. Soc. for Vasc. Surg. 2015, 50(4), 494–501.
   PubMed Web of Science ®Google Scholar
• Zhang, Q.; Bi, J.; Xiao, F.; Duan, H.; Wu, B.; Wu, Z. Production of Plasmid DNA Encoding Human Hepatocyte Growth Factor for Gene Therapy. Biotechnol. Appl. Biochem. 2008, 49(1), 11–16.
   PubMed Web of Science ®Google Scholar
• Chunsheng, H.; Qinglin, Z.; Yuxin, L.; Xiaochen, C.; Yanliang, W.; Tong, Z.; Zuze, W. A Continuous Cell Alkaline Lysis, Neutralization, and Clarification Combination Process for Production of Plasmid pUDK-HGF. Biotechnol. Appl. Biochem. 2011, 58(3), 162–165.
   PubMed Web of Science ®Google Scholar
• Goncalves, G.A.; Prather, K.L.; Monteiro, G.A.; Carnes, A.E.; Prazeres, D.M. Plasmid DNA Production with Escherichia coli GALG20, a pgi-gene Knockout Strain: Fermentation Strategies and Impact on Downstream Processing. J. Biotechnol. 2014, 186, 119–127.
   PubMed Web of Science ®Google Scholar
• Silva, F.; Passarinha, L.; Sousa, F.; Queiroz, J.A.; Domingues, F.C. Influence of Growth Conditions on Plasmid DNA Production. J. Microbiol. Biotechnol. 2009, 19(11), 1408–1414.
   PubMed Web of Science ®Google Scholar
• Williams, J.A.; Luke, J.; Langtry, S.; Anderson, S.; Hodgson, C.P.; Carnes, A.E. Generic Plasmid DNA Production Platform Incorporating Low Metabolic Burden Seed-stock and Fed-batch Fermentation Processes. Biotechnol. Bioeng. 2009, 103(6), 1129–1143.
   PubMed Web of Science ®Google Scholar
• Ow, D.S.; Yap, M.G.; Oh, S.K. Enhancement of Plasmid DNA Yields During Fed-batch Culture of a fruR-knockout Escherichia coli Strain. Biotechnol. Appl. Biochem. 2009, 52(1), 53–59.
   PubMed Web of Science ®Google Scholar
• Carnes, A.E.; Hodgson, C.P.; Williams, J.A. Inducible Escherichia coli Fermentation for Increased Plasmid DNA Production. Biotechnol. Appl. Biochem. 2006, 45(3), 155–166.
   PubMed Web of Science ®Google Scholar
• Chao, Y.P.; Chern, J.T.; Lin, W.S.; Wang, Z.W. Development of a Fed-batch Fermentation Process to Overproduce Phosphoenolpyruvate carboxykinase using an Expression Vector with Promoter and Plasmid Copy Number Controllable by Heat. Biotechnol. Bioeng. 2003, 84(4), 459–466.
   PubMed Web of Science ®Google Scholar
• Carnes, A.E.; Luke, J.M.; Vincent, J.M.; Schukar, A.; Anderson, S.; Hodgson, C.P.; Williams, J.A. Plasmid DNA Fermentation Strain and Process-specific Effects on Vector Yield, Quality, and Transgene Expression. Biotechnol. Bioeng. 2011, 108(2), 354–363.
   PubMed Web of Science ®Google Scholar
• Birnboim, H.C.; Doly, J. A Rapid Alkaline Extraction Procedure for Screening Recombinant Plasmid DNA. Nucl. Acid. Res. 1979, 7(6), 1513–1523.
   PubMed Web of Science ®Google Scholar
• Meacle, F.J.; Lander, R.; Ayazi Shamlou, P.; Titchener-Hooker, N.J. Impact of Engineering Flow Conditions on Plasmid DNA Yield and Purity in Chemical Cell Lysis Operations. Biotechnol. Bioeng. 2004, 87(3), 293–302.
   PubMed Web of Science ®Google Scholar
• Cai, Y.; Rodriguez, S.; Hebel, H. DNA Vaccine Manufacture: Scale and Quality. Exp. Rev. Vacc. 2009, 8(9), 1277–1291.
   PubMed Web of Science ®Google Scholar