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Systematic downstream process development for purification of baccatin III with key performance indicators

机译：具有关键性能指标的浆果赤霉素Ⅲ纯化的系统下游工艺开发

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Performance and cost-efficiency of biotechnological processes largely depend on decisions made in early phases of process development. Experimental investigation of process alternatives, unit operations, mass separating agents and operating conditions should therefore follow a systematic approach. Results should be evaluated and alternatives benchmarked with the aim of designing the most cost-efficient total process. Key performance indicators can meet this demand prior to availability of complete process concepts or mass balances.In this paper utilization and benefit of purification performance index (PPI), purification fingerprints and separation cost indicator (SCI) are demonstrated for the example of an experimentally-based downstream process development. Adsorption is investigated as a first purification step to separate baccatin III, a precursor of the anti-cancer drug paclitaxel, from the supernatant of a plant cell culture of Taxus baccata. Nine sorbents and 11 solvents (desorbents) are screened at different phase ratios. Concentration changes of the target substance and 13 major contaminants are evaluated and rated by costs with key performance indicators to find an optimal process concept.As a result, 94% pure baccatin HI can be obtained from filtered fermentation broth by a simple low-cost downstream process consisting of three steps only: adsorption, washing and desorption.
机译：生物技术过程的性能和成本效率在很大程度上取决于过程开发早期阶段的决策。因此，对工艺选择，单元操作，质量分离剂和操作条件的实验研究应遵循系统的方法。为了设计出最具成本效益的总过程，应该对结果进行评估，并对替代方法进行基准测试。关键性能指标可以在完整工艺概念或质量平衡可用之前满足此需求。在本文中，以净化性能指标（PPI）的利用和益处，净化指纹和分离成本指标（SCI）为例，通过实验进行了验证-基于下游流程的开发。作为第一纯化步骤，研究了吸附作用，以从红豆杉植物细胞培养物的上清液中分离抗癌药紫杉醇的前体浆果赤霉素Ⅲ。以不同的相比筛选了九种吸附剂和11种溶剂（解吸剂）。通过成本和关键性能指标对目标物质和13种主要污染物的浓度变化进行评估和定级，以找到最佳的工艺方案，从而可以通过简单的低成本下游工艺从过滤的发酵液中获得94％的纯浆果赤霉素HI该过程仅包括三个步骤：吸附，洗涤和解吸。

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