Wednesday, October 2, 2013
This paper provides an overview of the process used at Gallus BioPharmaceuticals, a cGMP contract manufacturer of mammalian cell biologics, to select and implement a SU biomanufacturing strategy and why the GE FlexFactory platform was chosen as the best solution. As an experienced contract manufacturing organization (CMO) Gallus aims to consistently deliver the right amount of manufacturing capacity to its clients, either via a “pay per batch” approach or via virtual ownership of capacity (SuiteSPACE™ Model), as well as operates a clinical services suite (CSS) according to cGMP standards, and accommodate all types of early-phase mammalian cell culture processes and products. The need for such flexibility made the decision to use a SU manufacturing system the obvious choice. The paper describes the challenges encountered and strategies implemented in selecting the right system.
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