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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Big data to smart data: Implementing an ontology and digital data capture to improve biomanufacturing
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
space and then carried out an initial proof-of-concept (PoC) implementation of ontology-enabled analysis. The results demonstrate how implementing better data management as part of a digital transformation can create compounding value over time.
Ethylene oxide (EtO) is one of the most widely used sterilization methodologies in the biopharmaceutical industry. However, the US Environment Protection Agency (EPA) has issued proposals for a five-year timeline for cycle redesign and compliance to reduce EtO used in existing products to ≤500mg/L and two years for new products to market. The biopharmaceutical industry understands the rationale for the proposed changes but thinks the...
This BioPhorum approach aims to define the polymer-based transfection reagent release testing needed for cell and gene therapy processes.
The BioPhorum Closed Systems in CNC space team have collated a terms relevant to closed systems and closed processing derived from multiple sources, including the FDA, EU EudraLex Volume 4, various WHO documents, ICH Documentation, ISPE documents and ASME.
This document outlines a general strategy for drug substance and/or drug product manufacturing processes expected to undergo process performance qualification with considerations unique to gene therapy. It addresses the specific requirements of the gene therapy industry, as general validation templates from the biologics industry may not be entirely applicable.
This chapter focuses on current regulations and guidelines mentioning and supporting the implementation of closed systems as a contamination control measure in the product protection strategy.
This paper sets out the rationale and approach to conduct a ‘tabletop exercise’ (TTE) that explores the readiness of operational technology (OT) and information technology (IT) support organizations to handle a
cybersecurity incident impacting a manufacturing plant. It describes the value of a lessons-learned exercise after the event to make improvements to processes and ways of working.
MediPhorum response to Annex XV restriction report proposal for a restriction on per- and polyfluoroalkyl substances
This response to Annex XV restriction report proposal for a restriction on per- and polyfluoroalkyl substances from the European Chemicals Agency (ECHA) has been submitted by MediPhorum, a global medical technology collaboration within BioPhorum comprising major manufacturers and suppliers of medical technologies from the biopharma sector.
This BioPhorum document focuses on cybersecurity vulnerability management, considering the challenge of exploitable code and protocol weaknesses, and how to address these. We consider why the threat landscape is changing and offer some ideas about its effective