WuXi Biologics can design and implement comprehensive stability testing and storage programs to meet regulatory and client requirements. Client developed stability assays can be transferred to WuXi for verification, additional development/optimization and validation or WuXi can conduct preformulation and forced-dedgradation studies to determine the appropriate stability-indicating assays.
Validated Storage Conditions
All temperature and humidity conditions needed to comply with ICH guidelines can be provided:
25 ± 2°C / 60 ± 5 %RH
30 ± 2°C / 65 ± 5 %RH
30 ± 2°C / 70 ± 5 %RH
40 ± 2°C / 75 ± 5 %RH
-20 ± 5°C
-40 ± 10°C
-80 ± 10°C
Liquid Nitrogen (LN2)
Alternate custom conditions can also be created to meet special needs.
Development and Validation of Stability-Indicating Assays
The design of stability programs includes the process of selecting the most appropriate stability-indicating assays and the rationale for those choices. Test articles can be subjected to various conditions to induce product breakdown (e.g., heat, agitation, oxidation or reduction). The analytical assays are then screened for ability to detect various product breakdown components. Stability assays are designed and validated according to ICH standards to meet or exceed the standards demanded by regulatory authorities worldwide. Programs can also include formulation assessment studies to ascertain how various formulations can affect product stability. The following methods are commonly used as stability indicating methods including SE-HPLC, IEX-HPLC or cIEF, CE-SDS (or SDS-PAGE), and potency assay, etc.
Other Product Characterization Methods
We offer other characterization or compendial methods that are also a critical part of many studies. These include sterility, bioburden or bacterial endotoxin testing, pH, visual appearance, particulates determination, Karl Fischer moisture determination and osmolality.