OPM formulation development platform provides our clients with rapid & reliable formulation development services, including pre-formulation research, formulation development and optimization, freeze-drying process development, packaging material screening, compatibility and stability studies, etc.

 

The platform is equipped with state-of-the-art instruments, including Uncle, MFI, HPLC, Maurice, lyophilizer, refrigerated centrifuge, etc. Our formulation scientists have extensive experience in data analysis and are experts in biopharmaceutical development, most of whom have led or participated in IND submissions in both China and the US.

Pre-formulation research

Formulation Development and optimization

Formulation process development and optimization

Packaging material screening and compatibility studies

Stability studies

Case Study

Monomer content measured by SEC-HPLC. Under different conditions, the monomer content of the same formulation stays largely unchanged, indicating highly stable formulation. The temperature factors are: long-term & stable 2-8℃, accelerated study at 25℃, and freeze-thaw condition.

Charge variants content compared with the main species measured by CEX-HPLC. The ratio of charge variants and the main species stays largely unchanged, indicating highly stable formulation. The temperature factors are: long-term & stable 2-8℃, accelerated study at 25℃, and freeze-thaw condition.

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