Regardless the type of biopharmaceutical (proteins/peptides, virus, nucleic acid), WuXi AppTec can design and implement comprehensive stability testing and storage programs to meet regulatory and client requirements. We have performed product storage and stability analysis for a wide variety of biologics including.
Monoclonal Antibodies • Recombinant Proteins • Peptides • Viral Vaccines or VLP Vaccines • Virus or Plasmid-based Gene Therapy Vectors • Cellular Therapeutics or Whole Cell Vaccines • Combination Products (Biologic + Medical Device)
Storage and Testing Programs
- 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.
- Analytical Methods
A variety of methods are available for use in stability studies. These include HPLC (IEX, RP, SEC), ELISA/Immunoassays, SDS-PAGE, IEF, Western Blotting, capillary electrophoresis, flow cytometry, spectroscopic and colorimetric methods for determining concentration, as well as nucleic-acid-based amplification methods (e.g., PCR and qPCR). A range of cell-based, immunoassay or virology potency assays can also be developed on a custom basis.
- Other Product Characterization Methods
WuXi AppTec offers other characterization or compendial methods that are also a critical part of any stability study product analysis profile. These include sterility, bioburden or bacterial endotoxin testing, pH, visual appearance, particulates determination, Karl Fischer moisture determination and osmolality.