Gallus offers analytical development services to support process improvements. We also develop and perform assays for product characterization or the development and transfer of methods for quality control for product release, in process testing and validation activities.
Targeted Services
- Analytical method validation in accordance with ICH guidelines
- Compendial method verification for product testing
- Analytical method evaluation, improvements and transfers
- Protein structure elucidation and post-translational modification characterization
- Pre-formulation and formulation development
- Upstream and purification process development support
- Process characterization and validation support
- Comparability studies
- In-process, release and characterization testing
- Platform analytical methods for mAbs
- Cell bioassays and ELISA
- Stability storage and testing
- Microbial testing
- Raw materials testing
- Reference standard/materials fill, qualification