Pfizer, BioManufacturing Sciences, Grange Castle International Business Park, Dublin, 22, Ireland,
Adv Biochem Eng Biotechnol. 2014;139:245-56. doi: 10.1007/10_2013_258.
Product lifecycle management refers to the oversight process and activities carried out to fully realize the commercial potential and value of a product in the marketplace. It is typical for many changes to be introduced to the production processes and testing methods for biopharmaceutical drugs over their lifetime in the commercial marketplace. Technology lifecycle management, as discussed here, refers to the management of the different phases or generations of processes and methods used to make and test the active biopharmaceutical ingredient or drug product, and the adoption of different devices used to present the drug product to patients. The factors to consider when making changes to a commercial biopharmaceutical manufacturing process as part of a technology lifecycle management program are discussed. A case study outlines one approach taken in bringing forward a major process change to a cell culture process for the production of a therapeutic recombinant protein.
产品生命周期管理是指为充分实现产品在市场中的商业潜力和价值而进行的监督过程和活动。在商业市场中，生物制药产品的生产过程和测试方法在其生命周期内通常会进行多次更改。此处讨论的技术生命周期管理是指对用于制造和测试活性生物制药成分或药物产品的不同阶段或代工艺和方法的管理，以及对用于向患者提供药物产品的不同设备的采用。讨论了在技术生命周期管理计划中对商业生物制药制造工艺进行更改时需要考虑的因素。案例研究概述了在推进治疗性重组蛋白生产的细胞培养工艺重大工艺变更方面所采取的一种方法。
