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CHALLENGES IN THE CONSTRUCTION OF A MULTI-PRODUCT VACCINE FACILITY

机译：多种疫苗设施建设中的挑战

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A new multi-product vaccines facility in Sanofi Pasteur was designed and equipped with new state-of-the-art technologies. The construction of this building aims to increase capacity of producing pediatric vaccines and allowed to implement manufacturing process improvements, increase quality compliance level and addressed environmental, and safety concern. This new facility harbors three antigens processes from fermentation to purification and detoxification. The project has been challenging on different points: new equipment, process transfer issues, new qualification/validation strategy and regulatory registration. Apart from global feedbacks on costs, organization, resources, performance and authorities communication strategies, focus was also directed towards the resolution of a process issue during validation steps. A trouble- shooting group has been mobilized to work on the different axes with a specific method. Resolution of all the issues permitted the building registration, and therefore the vaccination of millions of children.

机译：赛诺菲巴斯德（Sanofi Pasteur）新建了一个多产品疫苗设施，并配备了最新技术。该建筑的建设旨在提高生产儿科疫苗的能力，并允许实施制造工艺改进，提高质量合规水平并解决环境和安全问题。这个新设施包含从发酵到纯化和解毒的三个抗原过程。该项目在不同方面具有挑战性：新设备，过程转移问题，新的资格/验证策略和法规注册。除了在成本，组织，资源，绩效和授权机构沟通策略方面的全球反馈之外，重点还在于验证步骤期间解决流程问题。已动员了一个排障小组，以一种特定的方法在不同的轴上工作。解决所有问题可以进行建筑物注册，因此可以为数百万儿童接种疫苗。

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来源
《Vaccine technology VI》|2016年|222-222|共1页
会议地点 Albufeira(PT)
作者
Rachel Appetiti; Fabien Barbirato; Gaelle Bernard; Vincent Dalbies; Catherine Jourdat; Nadege Leray; Gregory Piquet; Christelle Plantard; Nadege Poisson;
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作者单位

Sanofi Pasteur, France;

Sanofi Pasteur, France;

Sanofi Pasteur, France;

Sanofi Pasteur, France;

Sanofi Pasteur, France;

Sanofi Pasteur, France;

Sanofi Pasteur, France;

Sanofi Pasteur, France;

Sanofi Pasteur, France;

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会议组织
原文格式 PDF
正文语种 eng
中图分类
关键词
building; fermentation; process; regulatory affairs; troubleshooting; validation;

机译：建造;发酵处理;监管事务;故障排除;验证;

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CHALLENGES IN THE CONSTRUCTION OF A MULTI-PRODUCT VACCINE FACILITY

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