产品详细信息
- 安捷伦位于博尔德和弗雷德里克的寡核苷酸生产工厂自 2015 年以来定期接受美国食品药品监督管理局 (FDA) 检查，并持续成功通过检查
- 这两个安捷伦工厂成功通过了生物技术平台和大型制药公司客户的 100 多次审计
- 成功实现了规模放大和 cGMP 生产，通过多次数千克级（单个批次最高达 20 kg）的生产活动得到了证明
- 内部分析检测包括自动滴定、库伦滴定水分测定、内毒素分析、FTIR、GC、HPLC 和卡尔费休水分测定
- 其他内部分析评估包括金属分析、核磁共振、渗透压、总有机碳、相变熔解分析、紫外光谱法和粘度测定
- 从试验性新药 (IND) 到新药申请 (NDA) 和生物制品许可申请 (BLA)，由安捷伦专家负责分析方法的转移、开发、确认和验证
- 分析方法经开发、确认及验证，可用于原料、过程检测、放行测试和稳定性测试
- 安捷伦检测涵盖供应链和生产工艺的各个方面，从原料到过程检测和最终放行
- 产品样本
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Accelerate Your Journey from Clinic to Market
Produce high-quality oligo APIs and efficiently advance from clinic to market, delivering therapeutics to patients with unmet medical needs
- 产品样本
- English
- 2023 年 12 月 28 日
- 3.19 MB
- 宣传单页
视频
Agilent to Acquire North American CDMO BIOVECTRA
Agilent Technologies signed a definitive agreement to acquire BIOVECTRA, a leading specialized contract development and manufacturing organization, for $925 million. Based in Canada, BIOVECTRA produces biologics, highly potent active pharmaceutical ingredients, and other molecules for targeted therapeutics. This expands Agilent’s end-to-end biopharma solutions that accelerate drug discovery, development, and manufacturing.
- Agilent to Acquire North American CDMO BIOVECTRA
- 2024 年 7 月 22 日
Agilent Investing $725 Million to Expand State-of-the-Art Manufacturing Capacity for Production of Nucleic Acid-Based Therapeutics
Investment will double capacity to produce active pharmaceutical ingredients used in therapeutics for a broad range of diseases. The addition of two new manufacturing lines (known as Trains C and D) will enable Agilent to meet growing demand for siRNA, antisense and CRISPR guide RNA molecules. Agilent expects customer shipments from the expansion to begin in 2026.
- 2022 年 12 月 5 日