By applying industrial process at large scale, Lek/Sandoz is producing FK506 (tacrolimus) commercially. FK506 is important immunosuppressive drug used mainly after allogeneic organ transplant to lower the risk of organ rejection. This is granted patent in the USA, based on patent application (WO 2011/004008A1, EP2451955A1), which was submitted in 2011 by researchers from Sandoz and Acies Bio. Patent is protecting the use of complex enzymatic system encoding biosynthesis of unusual extender units allylmalonyl-CoA and ethylmalonyl-CoA. Inventors have demonstrated that by manipulation of this enzymatic system, it is possible to improve biosynthetic process for FK506 production, particularly lowering presence of FK506-structure related impurities. The presence of undesired impurities is significantly increasing cost of the downstream processes. Thus, this discovery has high industrial value.
F.32 International patent
COBISS.SI-ID: 4523896