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VTU Engineering GmbH sell "Manufacturing Science & Technology"

基本信息

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产品名称

Manufacturing Science & Technology

规格参数

  • 用途: 支持从后期工艺开发向商业化生物技术生产的过渡,帮助产品获得监管批准。
  • 原产国: 奥地利、德国、瑞士
  • 认证标准: 用于支持生物制品的化学、生产和控制(CMC)文件编制及监管申报活动。

其他信息

补充描述:

VTU Engineering's Manufacturing Science & Technology group supports development and production teams through the later stages of biotech product development and commercialization, serving as an experienced partner to help products reach approval. The transition from late-phase process development to commercial manufacturing is a pivotal and often complex step toward a successful launch, and the group brings deep experience in process characterization, including risk assessment, study design, design of experiments, and Monte Carlo simulation, alongside technology transfer between labs, sites, or CMOs, and process validation, applying ICH Q8 and Q11 guidelines, Quality by Design principles, and effective risk management and control strategies to bring pipeline products to market promptly.
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