Development of Purification Process
An IND application project needs to complete the downstream purification process development and prepare proteins with acceptable quality. Purification process development is performed by applying design of experiments (DoE), combining with the customer-oriented resins and excipients of high quality and purity, to meet the compliance requirement.
1. The cell culture materials are used for resin screening study along in the pool and mAb screening stages.
2. With well-defined monoclonal antibody, purification process is optimized and validated for the qualification.
3. Upon on QbD based process optimization, DoE is preferentially applied to the purification process development.
4. The specifications of materials, reagents, and excipients in use are strictly selected and reviewed to meet the regulatory compliance requirement.
1. High Efficiency and High Yield
With the complete and fully functioned facilities, adequate talent of manpower management, and protein stability study coordinated with purification process development, the overall process development cycle < 2 months.
The loading pH, conductivity, protein concentration, retention time, and other parameters are optimized to increase capacity, and the elution pH, conductivity, buffer type, and other conditions are optimized to improve the yield of target protein.
The yields of depth filtration, affinity chromatography, cation exchange chromatography, anion exchange chromatography, nanofiltration, and ultrafiltration are more than 95%, 95%, 85%, 95%, 98%, and 95%, respectively; the overall recovery rate is more than 60%.
2. High Quality
Protein quality: The purity of SEC-HPLC is more than 97%, the purity of non-reduced CE-SDS is more than 95%, and the CEX main peak is more than 50%. All tests meet the requirements of Chinese Pharmacopoeia and USP.
Residual impurities such as HCP, HCD, rProteinA, endotoxin, and bioburden satisfied the requirements of Chinese Pharmacopoeia and USP.
The Quality such as post-translational modification satisfied the requirements of Chinese Pharmacopoeia and USP.
Under the premise of ensuring compliance of resins and excipients, the sources designated or suggested by the customer were preferred.
Customized study protocols are provided to customers.
A mature modular platform, advanced testing instruments and equipment, and simultaneous investigation of multiple test indicators boost the early application of projects.
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