Reducing Upstream Processing Scale-Up Risks Using QbD

By Mario Becker, Tim Ward and Christel Fenge

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 culture to meet Cost of Goods (CoGs) objectives. The process must be robust to ensure high batch success rates with a low risk of contaminations and minimal variations in cell growth performance. The biological product must 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 during development. Doing so allows the early evaluation of products in the clinic and, therefore, effective resource allocation behind projects from the pipeline that are most likely to be successful all the way to the market.