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Novasep Finorga sell "CDMO services for ADC payloads"

y = mx + b

基本信息

524
31
12
3.7(36)

交易类型

出售

服务名称

CDMO services for ADC payloads

规格参数

  • 用途: 提供从工艺开发到cGMP生产的ADC(抗体药物偶联物)载荷全流程制造
  • 认证标准: 符合cGMP标准的ADC载荷生产
  • 监管状态: 支持cGMP框架下的工艺/分析开发、表征及实验设计(DoE)研究

其他信息

补充描述:

Novasep provides end-to-end ADC payload manufacturing, from process development through cGMP production. Services span R&D lab work, analytical and process transfer/familiarization, process and analytical development, process characterization, and design-of-experiments studies at batch sizes up to 10 g; kilolab-scale cGMP production for clinical trials, process validation, and cGMP commercial supply up to 500 g batches; large-scale cGMP production for clinical trials, process validation, and commercial supply up to 1 kg batches; and quality control covering method development, transfer and validation, in-process control, release testing, and stability studies.
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