We deliver scalable and robust GMP-compliant processes for viral vaccines.
We operate a range of different manufacturing scales and utilize diverse cell culture equipment for both adherent growth and growth in suspension. The scale ranges from high-throughput 20 mL up to 200 L bioreactors. The equipment ranges from shake flasks and cell factories to WAVE Bioreactors™ and from a host of stirred tank bioreactors from different vendors. Furthermore, Batavia has iCELLis® equipment available for process development (iCELLis® nano) and GMP production (up to iCELLis® 500). Our most recent addition to the manufacturing platforms is the novel scale-X™ high cell density bioreactor. The scale-X™ bioreactor has approximately the same output as the iCELLis®, but the bioreactor is much smaller in design therefore dramatically decreasing the production footprint.
We perform state-of-the art manufacturing of diverse viruses on par with literature using adherent cell culture, suspension culture, and microcarrier-based processes. For instance, when using the Vero cell line for a H1N1 influenza virus production, we obtained high virus titers (1 x 1010 TCID50/mL) in 5 L bioreactors as has been described in literature (Chen et al., 2011). For example, when using bioreactors to manufacture measles virus, we typically observe a maximum titer of about 5 x 107 TCID50/mL as has also been reported in literature (Weiss et al., 2012).
For product-specific protocol development, we utilize our generic manufacturing protocols and our SCOUT® technology. Hereto, a panel of commercially available production media and generic feed strategies are available for testing in mini-bioreactors to optimize cell growth, cell population doubling times, and to increase cell densities.