Are you working in cell culture research, development or manufacturing?
CellPort Analytics™ (CPA) is a secure, compliant SaaS-based application suite focused on defining and managing all assay workflows, activities, equipment, materials, personnel, data/calculations and projects used by CROs, CMOs, research institutions, bio-pharma companies and regulatory authorities in Advanced Therapy Medicinal Products (ATMPs) (cell and gene therapy) development and manufacturing at all stages of development (R&D, GLP, GMP).
CellPort Analytics™ brings predictability to the unpredictable world of ATMP (cell and gene therapy) development and manufacturing by managing the major sources of variation in assay execution, including human behavior, changes in supply chain, equipment calibration, staff knowledge and training, ambiguous assays, origin and lifetime of materials, including cells and cell-based calculations.
CellPort Analytics TM was utilized for GMP release testing of a commercially approved gene therapy product. CellPort Analytics TM 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).