SBIR-STTR Award

Recently we have observed a massive outbreak of Ebola virus. This family of virus causes a significant bioterrorism threat due to the high levelof mortality, rate of transmissibility and the lack of an approved vaccine or therapy directed against it. The goal of this proposal is to develop,optimize and scale-up a mammalian cell culture-based bioprocess for the rapid manufacture of an antibody-based immunotherapy againstSudan virus. During this project BioFactura will generate two clonal suspension-adapted cell lines with high levels of specific and volumetricproductivity (Qp >30 pcd and 1 g/L, respectively) using the StableFast Biomanufacturing Platform. The system uses a multiplex selectionstrategy coupled to an innovative means to facilitate high copy number thereby significantly increasing the level of productivity and reducingdevelopment timelines. A robotic automation system that enables a high-throughput screening combined with high-resolution imaging will beuse to rapidly isolate and document high-performance clones. The innovative methods proposed herein will generate commercial-grade,highly productive mammalian NS0 cell lines that are rapidly scalable in single-use bioreactors for emergency surge supply. At the end of thisproject, 50 mg of antibodies will be produced from the lead and backup clones for each mAb component.

The Phase II strategy proposed provides for the development and optimization of a feasible, rapidly scalable, single-use manufacturing platform for the production of a mAb directed against Marburgvirus. Application of BioFactura’s StableFast patented manufacturing platform will result in an economically-produced mAb therapeutic with consistent, targeted properties for safety and efficacy. Characterization of both the product and process in accordance with Phase I clinical requirements will be performed as well as the identification of high-risk parameters at commercial scale. In-process and release assays will be qualified for these purposes. The intimate process knowledge gained throughout these experimentation and intensification efforts can be directly funneled back into the improvement of clinical manufacturing activities during SBIR Phase III continuation.