With the primary purpose of streamlining technology transfer and enabling accelerated “scale-out” approaches for clinical and commercial manufacturing, GSK is expanding the mAb manufacturing supply chain network to adopt a flexible 2000 L single-use bioreactor platform. The increase in flexibility gained, particularly for multi-product manufacturing across a broad range of products with varying cell culture productivities, has resulted in a re-evaluation of the facility-fit methodology that is applied in downstream equipment selection and unit operation design during product-specific technology transfer. In this presentation, using select examples, we will discuss key challenges and the development of a process-fit methodology for maintaining operational flexibility while minimizing potential clinical product comparability risks that may arise during transfer and scale-out. A key element to be discussed is the introduction of multi-day and accelerated multi-cycle chromatography approaches that selectively incorporate single-use technologies for closed processing while using existing clinical manufacturing equipment and column hardware. The developed approach remains in accordance with classic downstream process scale-up methods and ensures functional equivalence of the process, relative to that expected in commercial production.

Introduction of a flexible 2000L single-use bioreactor platform: Technology transfer and process-fit challenges in downstream processing

255th National Meeting (2018)

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