This paper provides a commentary on the analytical methods used for the release and/or characterization of full, partially filled, and empty capsids in various process development step and clarifies which analytical methods are amenable to GMP validation for product release in late-stage clinical trials and commercialization of gene therapy products.
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As a first step toward defining an industry-accepted ontology, the BioPhorum Technology Strategy Big Data to Smart Data workstream has reviewed best practices for ontology development across industries, adapted them to the biomanufacturing
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