How scalable is the Vertical-Wheel Bioreactor?
Thanks to the unique design of the Vertical-Wheel impeller, the mixing characteristics of the Vertical-Wheel Bioreactors are very homogeneous across all scales. This includes mixing time, average shear rate, and turbulent energy dissipation rates. This homogeneity greatly facilitates process scale-up from small development volumes (100mL) to full production volumes (3-80L).
Can Vertical-Wheel Bioreactors be used for vaccine production?
Vertical-Wheel Bioreactor Systems can be operated as closed systems and can handle high containment requirement applications as well as cGMP operations. The low shear environment in the VW Bioreactor and the platform’s scalability can potentially expedite and improve virus and vaccine production.
Is the Vertical-Wheel Bioreactor qualified for cGMP applications?
There are three tiers of qualifications for PBS products: IA, FA, and GA. IA Grade products have limited certification or quality claim and are intended for early-stage R&D and process development. FA grade products are qualified for clinical use and are intended for customer “First in Human” use of therapeutic drug product. GA grade products are qualified for cGMP use and are intended for customer commercial cGMP use for the therapeutic product they manufacture.