Stability Testing of Biologics and Biosimilars
Intertek offers stability testing and storage (including advanced analytical support) for evaluating biologics and biosimilars, such as recombinant proteins, monoclonal antibodies, and vaccines.
Large molecule drugs (biologics, biosimilars) are often very sensitive to environmental factors and require advanced analytical capabilities integrated with cGMP-compliant stability programs to evaluate their quality with time stored under various conditions of temperature and humidity.
Stability Testing of Biologics and Biosimilars
Stability studies for biologics and biosimilars can require a diverse range of analytical techniques conducted in accordance with GLP or cGMP requirements such as:
- 1-D and 2-D SDS-PAGE
- Western blot
- Isoelectric focusing
- Amino acid analysis
- Capillary electrophoresis (CE)
- Peptide fingerprinting
- Peptide mapping and sequencing by LC-MS/MS
- Total protein quantification
- Glycan characterization
- Immunochemistry techniques
Alternative analytical techniques may also be required to investigate post-translational modifications such as:
- Di-sulphide bridge mapping by MALDI-MS
- Carbohydrate analysis
- Secondary structure and aggregation status by dynamic light scattering
Stability study requirements are described in ICH guidelines Q1A(R2) "Stability testing of new drug substances and products"and, Q5C "Quality of biotechnological products - Stability testing of biotechnologicals / biological products". During early development, accelerated stability studies can help provide key data and information on the effect of short term exposure to environmental conditions otherwise typically performed over a 6-month period. Long term stability studies (12-months and longer) allow evaluation of the quality of the drug both during and beyond its projected shelf-life.
Related Biologics/Biosimilars Services
Request more information to see how Intertek can help your organization with Stability Testing of Biologics and Biosimilars.