蛋白稳定剂
无菌液体应用需要最高质量、纯度和可靠性的赋形剂。我们全面的优质药用赋形剂产品线可覆盖您的所有药用产品要求，并享有Emprove®计划监管和质量支持，可助您简化审批准备工作、加速研发进程。如果您的目标是小剂量或大剂量注射用药成功上市，可借助我们的行业专业知识、监管专长和全面的记录，助您自信地推进相关进程。
用于生物分子的高品质蛋白稳定剂
我们的高品质糖、多元醇、氨基酸和表面活性剂产品线专为高风险应用开发，可在您面临关键挑战时——如在生产工艺防凝聚——简化选择。其优势包括：
- 低内毒素和微生物限
- 符合ICH Q3D的元素杂质信息
- Emprove®计划和记录文档支持风险评估工作
- 提供专用于高风险应用的Emprove® Expert GMP级产品
相关产品资源
- Pharma’s Almanac: Accelerating Biologics Development with High-Quality Protein Stabilization Excipients
About protein instability and aggregation in biologic drug formulation, and how to overcome these challenges.
- Article: How to Prevent Protein Aggregation Using Stabilizers and Surfactants
Read about critical factors in long-term stability of proteins, and how different stabilizers protect against mechanical and thermal stress.
- Article: Low-in-Nanoparticulate-Impurities Sucrose for Biopharmaceutical Formulations
Read about a purification process resulting in low-NPI sucrose to achieve more stable protein formulations.
- Poster: Application of Excipients in Downstream Processing
Learn about the benefits on protein stability, chromatographic performance and viral inactivation.
- Whitepaper: Protecting Protein Stability with a Novel Grade of Sucrose
Get insights on NPIs found in commercially available sucrose, their origin and impact on protein stability.
- Whitepaper: Use of Excipients in Downstream Processing to Improve Protein Purification
Read about the effects of excipients on purification performance in Protein A chromatography and protein stability in virus inactivation.
- Whitepaper: Optimizing Poloxamer 188 for Use in Liquid Protein Formulation and Cell Culture Applications
Dive into stabilization mechanisms of poloxamer 188 and how to use attributes such as molecular weight and hydrophobicity to select the best option for liquid formulation and cell culture applications.
- Flyer: High-Quality Stabilizers for Your Biomolecules
Browse the flyer showcasing key features of our stabilizer portfolio.
- Formulation Product Finder
Quickly sort our excipients and API portfolio by dosage form, application, and many other parameters.
- Biopharmaceutical Application Guide
Explore products and services for mAb, vaccines, microbial, ADC, and plasma processes.
- Risk Mitigation Tool
Get guidance through the challenges and quality requirements of your bio-manufacturing process.
您想提高下游工艺的效率吗？
抗体和 Fc 融合蛋白的生产涉及多个下游加工单元操作。广泛使用的蛋白质 A 色谱纯化模板、低 pH 病毒灭活和随后的离子交换色谱步骤大多能够去除聚集物、宿主细胞蛋白质和病毒等杂质，这些杂质可能会影响产品的安全性和功效。
蛋白 A 色谱期间以及病毒灭活期间的低 pH 洗脱可能会导致聚集。在这些单元操作期间防止蛋白质聚集而不是在随后的精制步骤中去除多聚体是一种更有效的策略。想了解如何通过辅料最大程度减少最终产品制剂中的聚集水平的更多信息吗？点击下方图片查看我们的新海报“辅料在下游工艺中的应用”。
相关网络研讨会
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