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Merck
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上游化学品

工人装入上游化学品进行生物生产

我们的上游化学品系列种类齐全,不仅为生物制药企业提供经典和新型疗法生产所需的优质原料,而且还帮助他们加快产品上市速度并简化监管审批。我们的细胞培养基、纯化和原位清洗等产品涵盖从研究到商业应用的各个阶段,性能稳定可靠。同时,我们的供应链透明、全球供货稳定及一流的监管支持,简化您的审批流程。 

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相关资源

  • Article: Gradation in Pharmaceutical Manufacturing

    A look at industyr trends and how suppliers help. Involving quality raw material suppliers from the beginning of drug development can reduce many risk factors.

  • Data Sheet: Bulk Powder Transfer Bags

    The shift towards single-use disposables technology in bioprocessing has resulted in reduced facility costs, improved flexibility, and a decreased risk profile. While media and buffer preparation remain crucial in biopharmaceutical manufacturing, traditional labor-intensive methods pose risks related to containment and employee safety, highlighting the need for cleaner, safer, and more efficient processes in this aspect of production.

  • Product Guide: Raw Materials for Biopharmaceutical Manufacturing

    SAFC offers a portfolio of ready-to-use and customized material solutions designed to meet the specific needs of pharma and biopharma production, supported by deep regulatory expertise.

  • Product Guide: Upstream Chemicals for Bioprocessing

    Our comprehensive portfolio of upstream process chemicals provides high-quality raw materials for biopharmaceutical manufacturing, enabling faster market entry and simplified regulatory compliance. It offers consistent performance at every stage, supported by global supply chain transparency and best-in-class regulatory support.


Emprove® 化学品及其质量和监管支持

严格的生产工艺控制、优化的质量属性和精确的分析标准使得我们的原料非常适合生物制药的商业化生产。作为行业领先的Emprove® 化学品系列的一员,还可以进一步简化认证和风险评估流程。 我们的原辅料分类清晰,方便选择,同时每种产品均附带最新的详尽文档,以满足监管审批要求,控制风险并改进工艺。

  • 例如,Emprove® Evolve适用于生物制药生产的初期阶段,可弥补实验室级和GMP级原料和起始材料之间的差距,同时提供透明的供应链信息和文档。
  • Emprove® Essential适用于中度风险应用,符合IPEC-PQG GMP指南和/或EXCiPACT™认证标准,提供透明的供应链和专业的法规支持以帮助药品企业进行正式的风险评估。
  • Emprove® Expert适用于高风险应用,其中将微生物和内毒素水平降至最低是重中之重。除具备Emprove® Essential的风险管理功能外,Emprove® Expert产品线还满足低微生物和内毒素水平的生产要求,有助于整体风险遏制策略。

方便安全快速生产的大包装粉末转移袋

我们为各种生产规模提供1-100千克的散装粉末转移袋预装的原料,满足行业更快更灵活的生物生产要求。其称重精度在+/-0.5%以内,消除任何潜在误差并可直接对接接收容器,避免任何污染和员工安全相关的风险。这项服务可从缓冲液和培养基制备过程繁琐的清洗、反复称重和清洁工作,彰显了我们无止境追求生产效率和质量的经营理念。 



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