Development of recombinant human Alkaline Phosphatase (AP) as therapeutic protein in acute and chronic inflammatory diseases.

• Development of producer cell line based on CAP technology.
• Development of cell culture process and DSP for production of clinical batch recombinant human AP, including the process and product validation.
• Preclinical safety and efficacy evaluation of the rhuAP in in-vitro and in-vivo models.

The major goals of this THERAPTECH project are:

1. To demonstrate the suitability of the human cell based platform for production of highly glycosylated and sialylated proteins.
2. Enablement of future clinical development of rhuAP as anti-inflammatory therapeutic moiety in treatment of chronic inflammatory diseases, e.g. Rheumatoid Arthritis.
3. Demonstration of safety, efficacy and biosimilarity between the presently approved bovine derived intestinal AP and the newly developed rhuAP.

Clinical studies with bovine intestinal AP in cardio-surgery, variceal bleeding, organ transplantation and rheumatoid arthritis.