Process Development and Manufacture of an Antibody-based Therapy Against Marburgvirus

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.