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Professional Services

Analytical Method Validation

Providing clients with biologics-related analytical method development and validation services is an important feature that distinguishes us from other testing service providers. In the early phase of biopharmaceutical development, the establishment and validation of quality methods pose difficulties in quality analysis, consuming time and effort.
Hengyu biotech provides testing kit validation service and method development and validation services for dedicated detection method, focusing on drug quality research.

Development and Validation of Analytical Methods

Development and Validation of Analytical Methods

The testing items for biological products, especially the development and validation of some emerging alternative testing methods, are very important points in the quality research process. Hengyu biotech develops testing methods on a scientific and rigorous basis with reference to the regulatory requirements from the FDA, EMEA and Chinese authorities as well as the focus in the application process for new technologies, and carry out protocol design based on the appropriate principles in General Rule 9101 in the Chinese Pharmacopoeia (Volume III).

Validation items include:

  • Limit of detection (LOD)
  • Specificity
  • Robustness
  • Linearity
  • Range
  • Precision
  • Accuracy
  • Limit of quantitation (LOQ)

    Zhejiang Hengyu Biological Technology Co., Ltd

    Service Hotline:400-021-5980

    Service E-mail:service@hydetc.com

    Address:

    Building 41, Liandong U Valley, No. 168, Qiantangjiang Road, Economic Development Zone, Jiashan County, Jiaxing City, Zhejiang Province
    Building 18, Lane 2777 East Jinxiu Road, Pudong New Area, Shanghai, China

Zhejiang Hengyu Biological Technology Co., Ltd © 2021 沪ICP备20014472号-1 BY VTHINK
Building 41, Liandong U Valley, No. 168, Qiantangjiang Road, Economic Development Zone, Jiashan County, Jiaxing City, Zhejiang Province
Building 18, Lane 2777 East Jinxiu Road, Pudong New Area, Shanghai, China
400-021-5980
service@hydetc.com
copy © Zhejiang Hengyu Biological Technology Co., Ltd 2021