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口服固体药物的固态性质可以显著影响其药物性能。对原料药和制剂的固态进行完整的表征对于药物开发所有阶段的成功至关重要。
我们在固态化学、粉末表征和材料学研究方面的专家致力于加速您的原料药和制剂从临床前到商业化生产阶段的开发。我们拥有一支专门的科学家团队，每年在所有开发阶段共做了超过400个固态形式筛选项目和超过60,000个表征测试。我们也支持OEL 10 10ng/m3的高活化合物。
90+
Scientists
70,000+
Characterization Tests Annually
1,000+ m2
Lab Space
400+
Projects Annually
30+
Advanced
Instruments
支持原料药和制剂的完整新药开发生命周期
药物发现
临床前
临床I期
临床II期
临床III期
商业化
固态化学
用于毒理学研究和临床开发的盐/共结晶的筛选，多形态筛选
用于NDA申报的全面多形态研究
用于产品全生命周期整理的盐及多形态研究
固态表征
固形定量分析
结晶结构分析
模拟与建模
解决疑难问题
粉末表征
流动性 | 粒径 | 形态 | 表面积 | 密度
材料学研究
扫描电子显微镜-能量散射谱（SEM-EDS）| 微型计算机断层扫描（Micro-CT）| 拉曼光谱（Raman）| 润湿性 | 纹理分析
Discovery
Preclinical
Solid State Chemistry
Salt/cocrystal screening and polymorph screening for tox and clinical development
Solid State Characterization
Crystal Structure Analysis
Phase I
Phase II
Solid State Chemistry
Comprehensive polymorph study for NDA filing
Solid form quantitative method development
Simulation and Modeling
Phase III
Commercial
Salt and Polymorph study for Technical Life Cycle Management
Solid form quantitative method development
Trouble shooting
Characterization
Flowability | Particle Size | Morphology | Surface Area | Density
Material Science
SEM-EDS | Micro-CT | Raman | Wettability | Texture Analysis
Capabilities
- Solid form screening and analysis: salt and crystal form screening, co-crystal screening, polymorph relationship investigation, solid form developability assessment and single crystal analysis
- Solid state characterization: flowability, particle size, morphology, surface area and density
- Solid form quantitative method development
- High potency compound solid form screening and characterization
Various cutting-edge equipment to support general and specific testing
- X Ray Powder Diffraction (XRPD) with a Cryo-RH chamber
- Capillary X Ray Powder Diffraction (XRPD)
- DSC/mDSC and nano DSC (Differential Scanning Calorimetry)
- Thermogravimetric Analysis (TGA)
- Dynamic Vapor Sorption (DVS)
- Fourier-Transform Infrared Spectroscopy (FTIR)
- Confocal Raman
- Scanning Electron Microscopy (SEM) and Energy Dispersive X-ray Spectroscopy (EDS)
