Formulation Development
Including development and optimization of formulation and process.
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