BIBITEC Gesellschaft für Prozessentwicklung mbH - a member of NORDMARK BIOTECH - has around 20 years of expertise in process development based on mammalian cell cultures and in the production of active ingredients up to the 200-litre scale for clinical studies up to phase III.
In this context, BIBITEC developed the process and produced the entire phase III material of the active ingredient EPO-Zeta (the second EPO biosimilar approved by the European Commission; Retacrit®, Silapo®) for use in clinical trials, sponsored by BIOCEUTICALS AG, a subsidiary of STADA AG (Germany). BIBITEC founded the joint venture Norbitec with BIOCEUTICALS and NORDMARK for the market supply of EPO zeta. This joint venture was headed by Prof. Lütkemeyer for the first four years and is located on the Nordmark campus.
Customers and national authorities successfully inspected BIBITEC´s facility for several times. A general, valid GMP-certificate and a general production license for APIs to be used in clinical trials up to phase III are available.
Furthermore, for the analysis of samples from preclinical studies, BIBITEC was successfully GLP-certified by the national authorities in 2015.