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Lyophilization Technology, Inc. offer service "Clinical Supply Manufacturing Services"

基本信息

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子类别与细分类别

交易类型

提供服务

服务名称

Clinical Supply Manufacturing Services

规格参数

  • 服务类别: 冻干(真空冷冻干燥)及无菌灌装受托生产服务。
  • 监管认证: 该信息未详细列出具体认证;此类无菌灌装及包装作业通常在符合GMP的质量体系下运行。
  • 产能规模: 该信息未详细列出灌装/批次规模;此类无菌灌装线通常可覆盖从小型临床批次(数百至数千支)到全面商业化规模生产。
  • 地理覆盖范围: 国际覆盖范围广泛,几乎涵盖全球所有主要地区,包括中东、北美、中美洲、欧盟等。
  • 交货周期: 交货周期按项目报价,标准灌装/包装作业通常为数周,若需新规格、模具或验证批次则需数月。

其他信息

补充描述:

Lyophilization Technology, Inc. manufactures clinical supplies spanning sterile pre-clinical through Phase II materials, in both lyophilized and liquid form, packaged in vials, cartridges, bulk, or specialized delivery systems, with containment suited to biologics, cytotoxic agents, and highly potent APIs. Separate controlled areas handle warehousing, material prep, compounding, filling, inspection, and packaging, while the aseptic suite uses HEPA-filtered unidirectional airflow, containment, and isolation technology; the facility is inspected and approved for BSL-2 materials and qualified for containment and aseptic processing, with strict environmental controls supporting high finished-product purity across aseptic processing, isolation/containment, and dedicated/disposable, qualified and validated equipment.
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