Technology Roadmapping

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Knowledge mapping for the biopharmaceutical industry: A test case in CMC business processes from late-stage development to commercial manufacturing (paper and tool)

The management of knowledge in biopharmaceutical organizations has been recognized as an important challenge over recent years. Defining the pain points and designing successful knowledge management (KM) solutions have proven difficult. To address this challenge, BioPhorum Technology Roadmapping applied a KM best practice methodology to capture a process-based knowledge map for a major business process; this was performed by companies who develop and commercialize new therapies. The resulting assessment of knowledge flows revealed that there are significant challenges to both explicit and tacit knowledge flow across the control strategy and method development / technology transfer processes. Some generalized solutions have been proposed. As part of this work, a detailed spreadsheet tool was developed so that organizations can repeat this work on their business processes to understand their knowledge–flow issues and develop fit-for-purpose solutions.

The knowledge mapping tool is available here. Detailed instructions are available within the tool itself. The data in the sheet reflects that used in the illustrative example documented in the companion paper. The data is intended to be removed and replaced with end users data in support of their own KM efforts.

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Delivering globally on in-line monitoring and real-time release

BioPhorum is increasing its focus on delivering against strategic goals of member companies as outlined in the BioPhorum Biomanufacturing Technology Roadmap. The first step in achieving this is to form a team with a cross-Phorum focus to implement these technologies – the ILM/RTR Adoption team. The team will look at the ongoing work and opportunities to collaborate on environmental, organizational and technical factors that can be most readily addressed at industry level.

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Plug and play: The value of plug-and-play automation in single-use technology

Automation can improve efficiency, track performance, adjust operations, and liberate operators from mundane routines. Automation requires a flexible set of tools that align well with the inherent flexibility of single-use technology (SUT). Although SUT flexibility enhances a biomanufacturer’s ability to modify operations to meet the needs of today’s dynamic industry, it also increases timelines and costs related to customizing and validating automated additions. This paper presents the findings of a team of industry automation experts who are sharing their experiences and testing new automation methods, with a vision to a reusable, standardized approach that enables rapid integration of intelligent process skids.

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How plug-and-play will help you glide through the biomanufacturing dance

​​It is pretty clear that automation can improve efficiency, track performance and liberate operators from mundane routines. But with it comes cost and time factors around customization, communication and validation. So, the challenge is not just how to automate, but how to do it well. Using a ‘plug-and-play’ approach can greatly enhance the benefits of automation. By standardizing the communication framework, it can substantially cut the time...

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Buffer Stock Blending (BSB) System: Papers describing the project, drivers, concept and economic model

Buffers are critical inputs into all downstream processing steps associated with the manufacture of therapeutic proteins. The large volumes of buffer required present ongoing logistical challenges and account for a significant portion of a facility’s footprint, labor requirements and equipment costs. To address these challenges a collaboration of leading biopharmaceutical companies, engineering firms and suppliers has been working together to develop a design for a Buffer Stock Blending (BSB) System to support the preparation of buffers in-line and on demand from concentrated single-component stock solutions. These papers, in the first instance describe the project and activities up to the award of the contract to IPEC, the industry drivers for change and the novel approach to buffer preparation, and in the second paper deep-dive into some of the modeling work done to establish the economics and benefits of the approach.

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Rapid detection of bacteria and viruses: justification, regulation, requirements and technologies – how can industry achieve broad adoption?

One of the main targets for BioPhorum Technology Roadmapping is to reduce the testing times for bacteria (including mycoplasma), fungi and viruses in biological therapeutics from four weeks to just one or two days. The objective of this white paper is to identify industry barriers associated with adoption of alternative rapid microbiology methods (RMM) for the detection of adventitious agents and to understand how that can be best overcome. As such this paper provides an outline of the current methods for sterility, mycoplasma and virus testing in use and their limitations and lead times. Furthermore the paper explores the drivers for change and the main factors preventing the use of alternative RMM for testing to assure sterility and the absence of adventitious agents in the manufacturing process. Finally it recommends approaches that can be used to cost, justify and make adoption of new RMM technologies a reality to address the limitations of current practices.

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Removing the roadblocks to continuous biomanufacturing

Continuous downstream processing is increasingly seen as a feasible approach for manufacturing biologics. The industry recognises that it offers advantages over batch-based processing by: producing products with a more consistent quality attribute profile allowing greater flexibility to react to changes in market demands reducing up-front capital investment in facilities optimizing the cost of goods. However, despite these potential benefits,...

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