R&D service items

Stable expression of CHO cells (10L); 

Protein separation and purification; 

DOE experiment design for protein separation and purification; 

Transient expression test of 293T cells (1L); 

DOE experiment design for cell culture; 

Screening of stable strains; 

Isolation and purification of plasmid DNA. 

Quality control service items

Establishment of quality management system; 

Research on stability of stock solution and finished products; 

Purity analysis and full methodology verification; 

Peptide map analysis and full methodology validation; 

Microbial limit inspection of auxiliary materials and packaging materials; 

Sterility check and methodology validation; 

Inspection of residual solvents and methodology verification. 

Drug registration service items

Compilation of API pharmacy, preparation pharmacy, pharmacology and toxicology, and clinical data, etc. and preparation of application materials; 

Domestic new drug registration and acting for registration and declaration; 

Communication organization, progress monitoring and research data acceptance agent of pharmacological tests; 

Application, organization and implementation of CDE communication exchange meeting. 

Government policy service items

Help enterprises understand the relevant medical product support policies of the Ministry of Science and Technology, the National Development and Reform Commission, the Provincial and Municipal Science and Technology Commission, etc.; 

According to the enterprise project conditions, analyze relevant government funding support policies and select projects suitable for application; 

Prepare project application materials and feasibility reports according to specific project conditions; 

Consult relevant project review experts on specific issues such as feasibility reports and financial reports; 

Through specific guidance work, help enterprises greatly improve the possibility of winning project bidding and obtaining government project support.