The Manufacturing Process
Cytovac’s cancer therapy product, ALECSAT, is manufactured in purpose built GMP-approved production facilities, approved by the Danish Medicines Agency. Cytovac is 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. Audits frequently takes place.
The annual production capacity of the existing plant in Denmark is approximately 200 doses of the therapy; however, this capacity can be scaled in a 2nd manufacturing suite to meet the demands of the planned clinical trials or other partnerships where manufacturing capacity is needed.
Cytovac is continuously working to make the ALECSAT manufacturing process shorter, more efficient and robust. This includes research on developing methods for freezing both intermediate and final products which will facilitate a more flexible and scalable production flow as well as patients may only donate blood one time.
This work is an important step towards a successful commercialization of the ALECSAT therapy products.
