En avancerad immunologisk metod för att karakterisera terapeutiska antikroppar med hjälp av en liten mängd humant blod
Tidsperiod: 2013-01-01 till 2014-12-31
Budget: 1 400 000 SEK
This project aims to develop of a novel human ex-vivo whole blood loop system for an improved characterization of therapeutic antibodies in order to avoid irrelevant and unnecessary animal studies. Today various animal models are used to characterize the plethoric effects induced by therapeutic antibodies. As several factors such as cascade systems, Fc receptor interactions and species restricted target expression can confound the interpretation, such animal experiments are inadequate for assessment of efficacy and safety. A relevant human model system that could address complement, Fc receptor interactions and reflect the correct target expression pattern could Reduce, Refine and Replace many irrelevant animal studies. Most, if not all, of the in vitro based studies today are embark on purified cell populations in cell culture systems that lack complement and coagulation cascades. I propose to implement a novel human whole blood loop system to study both efficacy and safety issues around therapeutic antibodies. The project aims to develop and validate this system to be superior to animal studies such that it can be implemented in research and safety studies by both companies and academia. The work also aims to establish the method as an accepted tool to evaluate antibody safety in the eyes of Regulatory Bodies. I believe that this project can have a major impact on the 3Rs.