Technical challenges facing therapeutic cancer vaccines.

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.