The purpose of this paper is to share best practice and guidance for using the ‘Biomanufacturing digitalization readiness model’ (BDRM) published in Part 1: BioPhorum Digital Technology Roadmap (DTR)1. Visualizing the characteristics of a successful digital transformation, the BDRM is used to assess the organizational status of important attributes and identify gaps in need of attention.
POI - Technology Strategy
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This position paper and supporting personas from the BioPhorum Technology Adoption team address the issue of where to start our industry’s digital transformation journey. Part of the answer is data governance and the pressing need to collaborate and agree on a standard set of taxonomies and ontologies for the biopharmaceutical industry, recognizing that these standards will need sufficient flexibility to allow innovation. As a first step, we propose that the industry adopt The FAIR Guiding Principles for scientific data management and stewardship.
This paper aims to align and standardize the current industry approach to controlling a continuous monoclonal antibody (mAb) bioprocess. It builds on the BioPhorum risk assessment template that defined an integrated continuous bioprocessing control strategy. It distils complex interactions between bioprocess unit operations into three basic control building blocks. It considers the implementation and control of a continuous process, which mitigates potential process risks. It also defines a control approach based on the specific requirements of a given process using a conserved approach to linking the outputs and inputs between unit operations.
This BioPhorum member only document contains some of the typical biomanufacturing personas discussed in the BioPhorum Data Governance team.
This BioPhorum member only document presents the benefits, cost, risks, and timeline of participating in the pilot program for plug and play concept for automation in the biopharmaceutical industry
A structured approach for the evaluation, validation and implementation of NAT-based mycoplasma detection methods
This paper provides case studies and best practice guidance for validation of an alternative mycoplasma detection assay. It includes an example of completing a user requirement specification (URS) for evaluating an alternative mycoplasma detection assay, validation and implementation. Strategies are also provided to help identify suitable technologies for defined applications. Finally, a framework is given to demonstrate how a validation protocol for an alternative mycoplasma detection assay can be executed to meet the regulatory expectation that the alternative method is equivalent to or better than the current compendial methods.