This BioPhorum member only document contains some of the typical biomanufacturing personas discussed in the BioPhorum Data Governance team.
Critical persona template and worked examples
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Minimizing the impact of bioburden and sterility testing on gene therapy batch yield
The purpose of this paper is to assess and provide recommendations for reducing volumes required for testing of bioburden and sterility of gene therapy products including considerations for clinical stage and process stage (i.e. in-process vs bulk drug substance (BDS)). This paper makes recommendations for reducing the volumes required for testing and therefore conserving product for patients, while remaining compliant and delivering assay and process information on the microbiological status of gene therapy products.Â
Combination product essential performance requirements (EPR’s) interpretation and control strategy development – A MediPhorum appraisal
This presentation given by two MediPhorum subject matter experts at the Pre-filled Syringes east coast conference in April outlines the team’s findings on combination product essential performance requirements (EPR’s) interpretation and control strategy development
Cell and gene therapy aseptic process simulation reflections
This paper reviews and identifies gaps in existing guidelines on APS for ATMPs; outlines technical limitations and challenges; and provides recommendations on design and how some of the existing challenges may be addressed through risk-based approaches.
BioPhorum response to the Annex XV report on the proposal for universal PFAS restrictions
The BioPhorum response to the Annex XV Report on the proposal for universal PFAS restrictions. It is considered by the BioPhorum collaboration that unless ECHA provide the biopharmaceutical manufacturing industry with appropriate exemptions or derogations to find, test and validate alternatives and execute a transition out of these materials (where alternatives are available), there will be a real threat to the global availability of critical vaccines and biotherapeutics.
Labelling of CGT clinical drug product (DP)
A BioPhorum member survey examining approaches taken for labelling of allogeneic CGT clinical drug product.
PAT and Rapid Analytics supporting rapid manufacture survey
A BioPhorum member only benchmarking survey focusing on enabling rapid manufacture.
A proposal to align release standards for endonucleases used in nucleic acid removal
This BioPhorum peer reviewed paper proposes to unify current industry approaches with a single core standard of test methods and criteria necessary for GMP manufacturing. A common testing standard would have multiple benefits including consistency across suppliers, protection of supplier intellectual property, and facilitation of drug development.
Supply chain constraints benchmarking survey
This BioPhorum member only survey explores the challenges of the internal supply chain and the impact they are having on the business. One key theme that appeared to be emerging is that internal resource is a constraint within the supply chain for many companies.
Lead times best practice guide
Industry needs a common language and consistent understanding to reduce risk and ensure that both parties fully understand the requirements of a transaction. This paper contains industry-agreed definitions for terms such as total lead time, inventory days, and economic order quantity.
