Henogens Service Offer: From gene to patientThe FacilitiesHenogen owns top of the art clean room facilities, together with development laboratories and offices. Henogen operates in a 450 sqm GMP production facility, organized in seven BL2 and four BL3 rooms for the production, the purification and aseptic filling of clinical batches of therapeutical proteins, monoclonal antibodies, vaccinal viruses or viral vectors for gene therapy. The equipment complies with up to date GMP standards, BL2 rooms are dedicated to recombinant protein manufacturing and BL3 rooms for viral vectors manufacturing. The equipments, which include, i.e bioreactors, fermentors, incubators, centrifuges and protein purification systems, fully complies with current GMP standards.The early 2003 acquisition of a production site dedicated to the mammalian products has extended the process development area by another 700 m² . The acquired 250 sqm GMP area has been redesigned to feature a 300L bioreactor train operated in both perfusion and fed-batch modes. Those new clean rooms were inaugurated on Septembre 16, 2004. The TechnologiesHenogen’s production systems include all types of mammalian cell lines and yeast strains. Henogen uses various types of culture and fermentation conditions according to its customer needs but recommends for mammalian cells, the non-adherent and serum-free media procedures. Expertise in bacterial production systems is also available, up to now at the 150L fermentor scale.Henogen’s well seasoned and multidisciplinary team offers high level expression of recombinant molecules, development of validable downstream processes, comprehensive immunological analysis including animal models and organisation or supervision of phase I and II clinical trials. |