Consistent application of up-to-date Quality by Design (QbD) principles and practice (e.g., enhanced development) is essential in the Biopharm industry as regulatory expectations and new technology drive continuous improvement in product understanding and manufacturing processes. However, in many organizations the ultimate QbD practitioners are Scientists assigned to a single project, and it can be challenging for them to allocate time towards acquiring the most current QbD resources and tools for implementation in development projects. This can lead to inconsistencies across the organization when different elements of regulatory filings for different projects are compared (e.g., experimental design and technical risk assessment approaches, etc.).<br/>GSK’s Biopharm Process Development & Supply organization has implemented a Cross-Functional Technical Team model to address this gap by providing a development opportunity for Scientists to enhance their understanding of QbD principles and embed harmonized QbD practice within their technical lines. This poster will describe the formation and experiences of this QbD Cross-Functional Technical Team, composed of Scientists as well as other QbD practitioners across the upstream, downstream, analytical, and formulation development technical lines. In particular, the success of this team includes enhanced understanding of QbD principles and providing guidance for consistent application across multiple programs. Examples will be presented which highlight the impact of this concerted and aligned QbD approach on improving process development focused on achieving scientific rigor under increasingly demanding CMC timelines. To conclude, feedback from team members will also be shared, many of whom have developed QbD expertise and are currently involved with continuous improvement of tools, templates and methods for QbD implementation within GSK’s Biopharm organization.

Development of QbD expertise among scientists in a biopharm product and process development organization

255th National Meeting (2018)

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