◆ Understand the factors that affect protein stability and possible degradation approaches and product through stressing tests;

◆ Carry out high-throughput screening for preparation buffer system and auxiliary material to realize the high-efficiency development & optimization of preparation formula; 

◆ Perform rapid optimization and screening for preparation formula through DOE design; 

◆ Development, optimization, confirmation and scaling up of lyophilization process; 

◆ Comply with the long-term, accelerated, affecting factors, compatibility, and other stability studies of ICH guideline; 

◆ Selection and compatibility study of packaging material, packaging, and other drug container systems; 

◆ Development of relevant processes in formulation and filling.