Manufacturing

A completely individualised process

After the cancer diagnosis, a piece of tumour tissue is removed during cancer surgery in order to extract the tumour antigens. The tumour antigens are frozen until they are used. A leukocyte apheresis is performed as soon as the patient has recovered from surgery. This allows the collection of monocytes from peripheral blood. In the presence of Interleukin (IL) 4 and GM-CSF, monocytes are differentiated in culture systems into DCs (dendritic cells). The DCs are charged with the respective patient’s tumour antigens, exposed to the microbial danger signal LPS (lipopolysaccharide), and are finally frozen in liquid nitrogen in suitable aliquots. Subsequently, one of the cancer vaccine aliquots is recovered for quality control. If all specifications are met, the cancer vaccine is released for application to the patient. The cancer vaccine is inoculated into inguinal lymph nodes.

The entire manufacturing process, beginning with the leukocyte apheresis, takes approximately two weeks.

Out patient treatment and simple logistics

The challenge in individualised cancer immune therapy is to keep the manufacturing and logistics chain as simple as possible. Activartis’ therapeutic may be frozen and therefore stored for extended periods of time; the shelf life is two years. Shipment is done on dry ice, therefore only limited time constraints apply. In general, the entire batch for one patient is produced in one run. The vaccine may be applied in an out patient setting.