Drivers and barriers in the consistency approach for vaccine batch release testing: Report of an international workshop.

Safety and potency assessment for batch release testing of established vaccines still relies partly on animal tests. An important avenue to move to batch release without animal testing is the consistency approach. This approach is based on thorough characterization of the vaccine, and the principle that the quality of subsequent batches is the consequence of the application of consistent production of batches monitored by a GMP quality system.

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

Tumor vaccines play an increasingly important role in the therapy of various malignant diseases. The efficacy of these new products is currently being explored in many clinical trials all over the world. Cell-based tumor vaccines can be classified as somatic cell therapy, or, depending on whether genetic modifications have been applied, as gene-transfer medicinal products.