Spanish Biotech Platform
Plataforma de Mercados Biotecnológicos
Genhelix R 6 D Center
Genhelix (Leon, Spain) has concluded the commissioning of its R&D Center and Pilot Plant. The Center offers full service of process development and production of Monoclonal Antibodies and other recombinant proteins up to the 50 L scale.
Genhelix Development Center enhances the application of single use systems, improving safety and cost effectiveness of the processes.
The most relevant services include:
• Cell banking generation (RCB, MCB, WCB).
• Design and adaptation of culture media and scaling up of fermentation processes (upstream process) for mammalian and microbial cell lines. Titer up to 10 g/L.
• Development and improvement of purification processes for recombinant proteins and Monoclonal Antibodies at pilot plant scale, obtaining up to 500 grams for purified protein per run.
• Production of recombinant proteins (including MaB) for analytical purposes, diagnostic kits and preclinical trials.
• The full development of a bioprocess, from cell line reception to the manufacturing of the GMP runs usually takes around 18 months including: cell banking, process design and definition, scale-up, technology transfer and GMP documentation.
The new facilities serve both GHL’s in-house biosimilar projects of MaB as well as third parties’ projects. (Pharmaceutical companies, Universities, Research Institutes etc.).
The commercial GMP plant up to 6 x 2000 L single use with extensive utilization of disposable components is expected to be fully operative by 1Q 2012.