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Formulation Development

Including development and optimization of formulation and process.

Formulation Development
Formulation Development-1

Formulation Development

Services Offered

  • Develop-ability assessment. 
  • Formulation development and optimization, including buffer, pH range and stabilizer.
  • Formulation process development and optimization, including freeze-drying process development and optimization.
  • Packaging material screening and compatibility studies. 
  • Stability studies. 
  • Technology transfer and process scale-up to production. 
  • IND application and CTD material writing service.

OPM provides formulation development service for protein drugs such as monoclonal antibodies, bispecific antibodies, recombinant proteins, fusion proteins, and antibody-coupled proteins.

Extensive experience

  • 20+ projects of formulation development, and some projects have accomplished FDA and NMPA IND applications.

Professional team

  • Strong professional level in formulation development and rich experience in data analysis.

Advanced equipments

  • Equipped with state-of-the-art instruments, including Uncle, MFI, HPLC, Maurice, lyophilizer, refrigerated centrifuge, etc.

On time delivery

  • Deliver in 4 months on average

High difficulty formulation development

  • High concentration formulation development.

Services offered

  • Custom services catered to your specific needs