CellPort Software is the developer of the CellPort POWR™ platform, a modular and integrated application suite to manage the definition and execution of consistent, reproducible, compliant and scalable laboratory operations. CellPort POWR™ was developed in collaboration with industry leaders, including Absorption Systems, a world-class CRO developing and operating in vitro and in vivo assays to support drug development and manufacturing.
CellPort POWR™ was utilized for GMP release testing of a commercially approved gene therapy product. CellPort POWR™ was critical to success of over 50 FDA approved Biopharmaceutics Classification Systems (BCS) biowaiver approvals, a regulatory mechanism for drug developers to obtains waivers of clinical equivalence studies (wherein a cell-based assay replaces human testing).
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