Need to develop a new protein therapy?
We can help you! Our Product Development Team members have a solid scientific background, and the expertise and skills to answer any question from your production department, as well as enquiries from authorities such as FDA, EMA, and FAMHP.
Aside from investigating the feasibility, development and (pre-) validation of new analytical methods, we can support you with process updates and comparative studies, verifications and deviations management, as well as stability research. We can also assist you in guaranteeing viral safety of your product and perform risk analyzes where necessary.
We are here for you every step of your therapy development:
Stage I: Development
- Process Development (upstream and downstream), CPP/CQA
- Viro-inactivation step
- Formulation
- Pre-stability testing
- Analytical method development and/or
- Pre-validation of method and/or
- Biochemical product characterization
Stage II: Validation
- Process industrialization
- Single use device
Stage III: Control
- Process limits, stability, capability
- Product stability
We can also assist you in guaranteeing viral safety of your product and perform risk analyzes where necessary.
A detailed overview of our devices for analytical methods and lab scale processes can be found here.