G-CON completes delivery and installation of POD system in PaxVax's GMP production facility
Published on January 19, 2013 at 6:23 AM
G-CON today announced the completed delivery and installation of the ground-breaking POD™ system in PaxVax's licensed GMP production facility based in San Diego, California where PaxVax manufactures innovative and socially responsible oral vaccines against infectious diseases. After surveying the market for flexible and re-usable cleanroom options, PaxVax chose G-CON's POD™ technology for their processing needs, as it provided the most comprehensive solution. This, coupled with a shortened timeframe for delivery and setup, made the G-CON POD™ an ideal option. PaxVax will be utilizing the production facility for clinical and commercial manufacturing of their single dose oral cholera vaccine, which will be entering Phase 3 trials later this year.
Nima Farzan , PaxVax's Chief Operating Officer, stated: "G-CON understood our needs to quickly install a safe-contained solution that afforded us the flexibility and scalability we needed for our manufacturing facility. Their deep experience with design, construction and operation of the POD was evident when they completed the install within hours."
Barry Holtz , President of G-CON Manufacturing, stated: "We committed to an aggressive timeframe for delivery and installation of the custom-built POD, with the express understanding that PaxVax would be accountable for final design decisions on a short timeframe. By working closely with Nima and his team, we successfully moved from a conceptual design that had never been built before to installation of the 24 foot by 42 foot POD in a matter of 16 weeks."
The customized POD™ provides 768 sq. ft. of cleanroom space, a partial ceiling height of 15' and the capability to maintain relative humidity at 35 percent in a controlled non-classified environment. This POD is the first to be delivered into the State of California which presented a number of regulatory and engineering challenges, but having fulfilled the same will now pave the way for future California installations. Foster Wheeler Biokinetics, with whom G-CON recently announced a global alliance, collaborated on the engineering of the POD.