Genhelix (GHL) is a Multiproduct Plant consisting of a R&D laboratory with pilot plant for Process Development and small scale manufacturing and a GMP plant with an extensive use of disposable technology and dedicated equipment.
GHL is a "one stop facility" coverng the whole cycle of the process from clone construction and selection to the production at commercial scale.
Some of the main characteristics and advantages of our approach are:
Minimisation of Change Over times and cleaning operations. GMP compliance reducing cleaning validation concerns (no CIP, no SIP).
Reduction of the risk of cross contamination and microbial contamination.
Modular architecture and less space requirements. Total adaptability to the project (single access point for utilities etc). Protoplant ®.
Lower Documentation requirements, operations and less training needs.
Highest Efficiency, Flexibility, Quality and Cost saving compared to a traditional plant.
Capacity up to 750 kg/year of purified protein.
Development and Scale up services. Engineering andvalidation batches. Pilot scale comprised within the Development Center.
Full documentation provision. Regulatory dossiers support for a smooth relationship with the agencies.
Genhelix is a reliable CMO partner, financially solvent and independent. Technologically innovative and flexible, its activity covers from Process Development to Commercial Scale (up to 6 x 2000l SUBs, and 500 – 750 Kg purified protein per year.
GHL’s team includes human resources with a vast experience at both managerial and technical level at companies such as Genentech, Lonza, GSK, Antibioticos S.A., in bioprocesses definition and execution from the cell line to final formulation.
At GHL, our goal is to put our expertise at your service to get the best out of your projects.