Reducing upstream processing scale-up risks using QbD-enabling platforms and PAT tools


Scientists and engineers seeking to develop manufacturing processes for new biopharmaceutical drugs face a number of challenges

Upstream process development must deliver a high-yielding cell cultures to meet cost of goods (CoGs) objectives.

The process must be robust enough to ensure high batch success rates with a low risk of contamination and minimal variations in cell growth performance. The biological product must also maintain the required product quality attributes during scale-up from laboratory to commercial scale.

Biopharmaceutical companies must address these complex challenges in the shortest possible timeframe and at reasonable effort and cost levels during development. Doing so allows the early evaluation of products in the clinic and, therefore, effective resource allocation to support the pipeline projects that are most likely to be successful and eventually reach the market.

Adopting a platform approach to cell line development and using automated high-throughput miniaturised bioreactors allows companies to increase the speed with which they bring their products to the clinic. Complementing these techniques with a carefully considered approach to cell culture scale-up ensures right-first-time manufacturing.

The objective during scale-up is to seamlessly transfer the process from the laboratory through clinical trial manufacturing and process characterisation to commercial production. Doing so requires a high level of process understanding, which leads to greater predictability, flexibility and the avoidance of surprises when operating at large-scale.

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