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.
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
Analytical Method Validation
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)