We provide a complete service package for bio-similar development.
1. We’ll conduct high-fidelity sequencing of the originally marketed biologics to obtain accurate and complete protein sequence, as well as analyzing its N- and C-terminals, its disulfide bond linkage, its glycosylation pattern, and possible PTM.
2. Based on the sequence and other protein structure information, we’ll develop suitable cell lines (CHO, E. coli, yeast, etc.) for high-level expression of bio-similar substance.
3. We’ll carry out <1L expression of the product
4. We’ll carry out the purification of the expressed protein products.
5. We’ll carry out the physicochemical characterization of the expressed biologic product, including the confirmation of its complete amino acid sequence, its N-and C-terminal determination, its S-S bond linkage analysis, impurity analysis, glycosylation and PTM analysis, etc. We’ll conduct basic biological activity assay, such as affinity measurement for antibody drugs.
6. With the satisfactory of our client regarding the results from protein expression, purification, physicochemical characterization, biological activity, we’ll conduct comparability study using the originally marketed product as reference
7. We can sub-contract animal study or assist our client in conducting the animal study.
8. We’ll transfer all cell lines, expressed products, results, and related technology to our clients. Our clients will keep all the IP right.