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KBI Biopharma Inc. offer service "Formulation Development"

基本信息

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交易类型

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服务名称

Formulation Development

规格参数

  • Stability Indication: 通过热学、物理学、化学及构象稳定性表征,确立蛋白质的内在特性。
  • Excipient Selection: 采用统计实验设计(DOE)评估辅料及配方成分之间影响蛋白质稳定性的相互作用。
  • Dosage Form: 作为全球性的分析、工艺及配方开发合作伙伴,开发稳健、数据驱动的生物制品配方。

其他信息

补充描述:

This formulation development approach pairs two complementary disciplines: building a comprehensive understanding of a protein's intrinsic properties and stability through thermal, physical, chemical and conformational characterization, and evaluating interactions and key effects on protein stability using statistical design of experiments (DOE). This lets KBI develop robust formulations by removing uncontrolled stability variables, focusing on therapeutic performance and clinical outcomes, drawing on more than 130 successful protein, peptide and vaccine formulation development programs and delivering stable liquid formulations across protein concentrations from above 1 mg/mL to 200 mg/mL.
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