Ward Stephen, Copier John, Dalgleish Angus
Onyvax Ltd, St George's University of London, Cranmer Terrace, London, SW17 0RE, UK.
Curr Opin Drug Discov Devel. 2008 Mar;11(2):168-77.
Significant advances have been made in the development of therapeutic cancer vaccines, with vaccines for renal, colorectal and prostate cancers showing real promise. This review describes progress in the development of cellular vaccines, along with the technical challenges that have to be overcome to bring these vaccines to phase III clinical trials and commercial supply. The issues of large-scale vaccine design and production, the problems associated with scaling up, and the assessment of quality and yield are discussed. Regulatory guidelines for the production of cellular vaccines that have evolved alongside the technology for vaccine production over the last few years are also reviewed.
治疗性癌症疫苗的研发取得了重大进展，肾、结肠和前列腺癌疫苗展现出了真正的前景。本综述描述了细胞疫苗研发的进展，以及将这些疫苗推进到III期临床试验和商业化供应必须克服的技术挑战。讨论了大规模疫苗设计和生产的问题、扩大规模相关的问题以及质量和产量的评估。还回顾了过去几年随着疫苗生产技术一同发展的细胞疫苗生产的监管指南。
