缓冲液和pH调节剂
由于缓冲液在几乎每个生产步骤中都是必不可少的，因此缓冲液质量对于生物制药工艺以及小分子制剂的成功至关重要。我们广泛的缓冲材料在适当控制的条件下生产，可根据您的需求量身定制，涵盖Non-GMP/GMP生产的产品，包括药物制剂专用辅料和高风险应用。无论您的产品是小分子药物还是大分子药物，我们都会在监管支持下提供高质量的缓冲液和pH调节剂。
- 所有产品均在适当的控制条件下生产
- 多部药典（如果适用）
- 低生物负荷和内毒素水平
- 紫外线吸收率低的水溶液
- 全面的文档和法规协助
相关资源
- Article: Reproducibility with Biological Buffers
Biological buffers are organic substances that maintain a constant pH over a given range by neutralizing the effects of hydrogen ions.
- Brochure: Your Partner for Liquid Dose Applications
We offer an extensive portfolio of raw materials for liquid dosage forms, manufactured in compliance with the IPEC-PQG GMP Guideline, to support your pharmaceutical development, scale-up, and production needs. Backed by expert regulatory knowledge and the Emprove® Program, our high-quality excipients aim to simplify material qualification, accelerate processes, and reduce the total cost of ownership for your final product.
- Reproducibility with Biological Buffers
Biological buffers are organic substances that maintain a constant pH over a given range by neutralizing the effects of hydrogen ions.
- Tech Brief: Holistic Buffer Preparation
Buffer preparation is a critical but often undervalued operation in biologics production, with significant buffer volume consumption and potential process bottlenecks. This document will explore the optimization of in-house buffer preparation and considerations for outsourcing, recognizing that a combination of options may be the best solution based on process requirements.
- 缓冲液参考中心
这些表格按pH值和pKa值提供常用缓冲液的配制信息。根据检测性质选择pH范围适用的缓冲液。
- Product Guide: Raw Materials for Biopharmaceutical Manufacturing
The development of pharma and biopharma products requires materials as well as the expertise on how to use them. The SAFC portfolio of ready-to-use and customized material solutions were developed to meet the specific needs of pharma and biopharma production and backed by deep regulatory expertise.
- Formulation Product Finder
我们涵盖了所有常用的缓冲系统，例如磷酸盐、乙酸盐和柠檬酸盐，以及定制的缓冲液和有机缓冲液，包括TRIS、HEPES、MES、BIS-TRIS、PBS、咪唑等。如果您需要能够快速灵活交付的全球供应合作伙伴，我们在全球的生产基地可以提供根据GMP准则生产的高质量生物缓冲液，数量可以从克到公吨。
确保可重复性，同时将风险降至最低
所有缓冲产品均使用合格的高纯度原材料进行制备，这些材料都具有确定的规格，可确保可重复生产，同时采用旨在将微生物污染和浓度降至最低的工艺进行制造。因此，全球许多的药品制造商都依靠我们的产品来进行：
- 配制用于口服、局部、眼科、耳道、吸入或鼻腔给药的任何种类的液体药物产品
- pH和其他上游工艺参数的优化，以获得所需的产品特性
- 下游确定的纯化条件的维持，以稳定有价值的蛋白并防止污染
加快您药品审批的速度
作为我们Emprove® 化学试剂产品组合的一部分，缓冲液和pH调节剂得到了全面、最新的文档支持，可帮助您应对法规挑战、管理风险并改善工艺。
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