Protein Drug Development
Comprehensive Analysis Platform
Efficient Cell Line Development
Through GlycoNex’s integrated cell line development platform, the specified cell clones can be selected to meet the project goal. The strategy leads the project right from the beginning.
Dedicated Process Development and Scale-up
GlycoNex has remarkably superior process development capabilities in the mammalian cell system to ensure not only the optimum productivity and quality of our product, but additionally provided the flexibility to accelerate the development of our product. Our previous project experiences included monoclonal antibodies, fusion proteins, bispecific antibodies and biosimilars.
Upstream process Development
During upstream process development, GlycoNex optimizes cell culture parameters for productivity improvement and post-translational modification (especially glycoform) while ensuring process robustness and scalability. We provide:
- Fed batch shaking flask
- 1L and 5L bioreactors.
- 50L single use bioreactor (for Pilot scale production)
Downstream process Development
GlycoNex’s downstream process development team utilizes fast conditional screening platform approaches to speed up the product development, while always considering and adequately addressing the unique challenges that every proteins typically present. We provide:
- Chromatography: Affinity column, Ion-exchange column (CEX and AEX), multimodal column.
- Column size: Various size columns.
Cost Effective Pilot Production
GlycoNex provides 50L GMP-like pilot production to ensure the process scalability and supply materials for preclinical studies. The product qualities from GlycoNex’s pilot production achieve client and regulatory requirement.
Our manufacture team members are trained from process development to production scale-up. They fully understand the science behind each process.
Once the project is moving forward, GlycoNex is able to transfer the optimized process and documents to CMO for cGMP production maintaining comparable productivity and product quality.
Certified Quality Control System
GlycoNex provides the high quality services and products which meet the regulation and client requirement.