Biomanufacturing technology roadmap: 7. Knowledge management

Knowledge management is the process of capturing, developing, sharing and effectively using knowledge to drive a business, such as patient, product and process information. It is a multidisciplinary and cross-functional approach to both innovation and continuous improvement, ultimately enabling improved performance to achieve target metrics and other company objectives. It includes dimensions of people, process, content and technology. A robust and reliable knowledge management platform integrates product and process information across the development, manufacturing and commercial (sales) value streams. Information in a wide range of explicit formats, as well as tacit ‘know-how’, will be fully supported by the platform. Knowledge management will dramatically optimize resources, increase speed and improve efficiency. It will permit ‘near real-time’ access to all types of information creating overall visibility across the value stream as well as ‘nearly instant’ cross-product learning. Key drivers are focused to better understand the complex biopharmaceutical processes and to better control these processes for improved speed, quality and cost of product supply to our patients.

While the drivers for knowledge management exist in many industries, there are unique drivers that apply to the biopharmaceutical industry. Knowledge management is critically important to biopharmaceutical manufacturing as its processes become increasingly complex and the demands relating to supply are high (e.g. uninterrupted supply, lower costs, and higher regulatory and quality scrutiny). Data generation and volume is increasing, requiring an improved capability to manage the data and transform it into valuable information and knowledge that can be readily applied.

The key benefits from a strong knowledge management system are speed to market, cross-product learning and efficiency throughout the product lifecycle. Knowledge management significantly impacts cost, speed and quality metrics through explicit as well as tacit knowledge collection/capture, dissemination/sharing and enrichment/reuse.

• Cost – the embedded use of knowledge management tools for product and process knowledge and structured lessons learned results in efficient manufacturing processes, fewer errors and reduced cost of supply/development

• Speed – well structured and coordinated product/ process information management (i.e. the ‘findability’ of information) can significantly impact on the time to release product and time to introduce changes to an existing process

• Quality – improved management of multiple knowledge formats and easy access to information (i.e. findability) increases the capability to understand how critical process parameters (CPPs) impact on critical quality attributes (CQAs), improves control and reduces the occurrence of manufacturing out-ofspecification product.

The impact on specific metrics of well structured and coordinated knowledge management approaches increases towards the 10-year time horizon, due to the substantial growth in knowledge generation as the business and technology opportunities identified in the roadmap are realized.

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