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Lyophilization Technology, Inc. sell "Development Sciences"

基本信息

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4.2(69)

交易类型

出售

服务名称

Development Sciences

规格参数

  • 用途: 生物制药研发、生产或分析支持服务
  • 认证标准: 按cGMP生产,具备完整批次追溯及放行检验
  • 监管状态: 按照ICH指南支持监管申报(如BLA/MAA/NDA)

其他信息

补充描述:

Development laboratories are equipped to run a diverse range of experiments spanning formulation development, cycle design and process refinement, and finished product evaluation. Process development studies conducted within a pilot-scale manufacturing environment, including the use of ControLyo technology in process engineering studies, ease scale-up. Critical fill/finish areas operate within a certified HEPA environment that emulates aseptic operations for sterile products, and comprehensive development reports readily support regulatory submissions. Capabilities include low-temperature thermal analysis, product development, cycle design/refinement, vial and cartridge work, finished product testing, isolation/containment, and work with aqueous and organic solvents.
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