在整个生物药开发过程中，可信赖的高质量分析数据可以让我们更有把握做出正确的决定。苏州智享可以为客户提供全流程全方位的分析服务，不仅可以帮助了解分子的关键质量属性，制定可靠的质量控制策略，还可以进行产品表征研究。我们时刻关注最新的法规政策，不断升级技术配备，以便更快、更高效地为客户提供最完善的分析解决方案。
Reliable, high-quality analytical data is extremely important for making critical decisions with confidence throughout the development of biological drugs. At IntellectiveBio, we can offer diverse analytical services at any stage of the product development process, not only helping understand critical quality attributes of the molecule and define the robust control strategy, but also performing product characterization. With up-to-date knowledge of regulatory requirements and technologies, our scientists can provide our clients with well-developed analytical solutions in an efficient manner.
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提供工艺开发、处方开发所需的质量分析
Quality Analysis to Support Process and Form
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蛋白表征
Protein Characterization
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放行检测、稳定性检测以支持IND/BLA申报
Release and Stability Testing to Support IND/BLA Filing
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强制降解实验
Forced Degradation Study
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相容性研究
Compatibility Study
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方法开发/优化
- Method Development / Optimization
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方法确认/验证
- Method Verification / Validation
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方法转移
- Method Transfer
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