Cytovac’s cancer therapy product, ALECSAT, is manufactured in purpose built GMP-approved production facilities, approved by the Danish Medicines Agencies. Cytovac has been formally approved as a Cell and Tissue Centre under Danish legislation setting the standards for handling, quality and safety for products containing human tissues and cells and, is also, approved as an §39 pharmaceutical product manufacturing company.
The annual production capacity of the existing plant in Denmark is approximately 200 doses of the therapy; this capacity can be scaled to meet the demands of planned clinical trials including 2017 and 2018.
Cytovac has been, and still is, working to make the ALECSAT manufacturing process more efficient, robust and faster as well as better suited for large-scale production and distribution. Thus, the development of, for instance, methods for freezing both final and intermediate products will, facilitate a more flexible and profitable production flow and reduce material consumption and cost.
This work is an important step towards a successful commercialization and industrial upscaling of the manufacture of products used for ALECSAT therapy.
Today, the cells used for ALECSAT therapy may be shipped for 10 hours’ without loss of quality; but the transport and media for injection as well as transport temperature are currently subject to further optimization for the purpose of facilitating transport of the product over longer distances.