Evaluating Downstream Processing Options at the Bioprocess-business interface

传统上，单克隆抗体（MAb）治疗对患者和医疗保健提供者的成本很高。生成、纯化和配制药物所需的复杂过程大大增加了总成本。尽管已经努力通过提高生产效率来降低成本，例如，选择新的色谱序列和策略，但由于缺乏系统的框架来评估竞争性工艺配置的工艺-业务权衡，这一努力受到了阻碍。该项目的目标是生成基于计算机的决策支持算法，以评估未来单克隆抗体生物处理策略的操作和商业结果。通过将详细的过程经济模型、多目标决策分析和组合优化技术与过程-业务交互可视化的合适方法相结合，创建一个强大的整体工具，用于优先考虑具有成本效益的下游制造。

The cost to patients and healthcare providers for Monoclonal Antibody (MAb) treaments has traditionally been high. The complex process required to generate, purify and formulate the drug add significantly to the overall cost. Although efforts have been made to reduce costs by looking at increasing manufacturing efficiencies e.g., selection of new chromatography sequences and strategies, this effort has been impeded by a lack of a systematic framework to assess the process-business trade-offs of competing process configurations. The goal of this project was to generate computer-based decision-support algorithms that assess the operational and business outcomes of future bioprocessing strategies for MAbs. By combining detailed process economic models, multi-objective decision analysis and combinatorial optimisation techniques with suitable methods of visualising the process-business interactions to create a powerful holistic tool for prioritising cost-effective downstream manufacturing.