Analytical Method Development
The BDP maintains expertise for process and product analytical method development. This includes the following:
- Analytical method development to support well-characterized biotechnology products
testing for purity and identity
- Bioanalytical methods using receptor-based ELISA, cell-based methods and binding
measurements by BIAcore to show bioactivity and specificity
- Instrumental methods development using LC-MS and differential scanning calorimetry
to characterize biomolecules and develop stable formulations.
- Other method development to support glycoprofiling and molecular biology methods.
- Virus-based product testing and analysis including demonstration of viral clearance
from well-characterized biological products.