CDMO OEM Service
CDMO, Contract Development and Manufacturing Organization, is a form of outsourcing between industrial companies and provides required services to targeted corporate clients.
Diagnostic industry CDMO is a company that mainly provides IVD reagent/kit development and manufacturing services. The services provided include not only raw material selection, product research, development, stability study testing, but also capacity expansion, commercial production (finished products or partially finished products), etc. CDMO often has dual capabilities in R&D and production, which is also a strong reflection of its capabilities.
The Jiachun Diagnostic team has rich practical experience in CDMO and has established multiple technical application platforms for clinical diagnosis of different diseases. These platforms have been widely used and accepted by many customers and have been successfully applied in the field of in vitro diagnosis. If you are looking for an in vitro diagnostic outsourcing partner to enhance your product line, we can provide you with a rich one-stop service system to meet your actual needs.
Professional team provides simple and fast cooperation process
Professional team provides simple and fast cooperation process
Professional team provides simple and fast cooperation process
Professional team provides simple and fast cooperation process
Professional team provides simple and fast cooperation process
Professional team provides simple and fast cooperation process
Professional team provides simple and fast cooperation process
Professional team provides simple and fast cooperation process
Professional team provides simple and fast cooperation process
Professional Team Provides Simple and Efficient Collaboration Process
Define Biomarkers and Platform for Reagent Development
Define product parameters and standards for IVD reagents
- Identify disease-specific biomarkers
- Determine appropriate technology platform
- Specificity
- CV value
- Batch-to-batch stability
- Negative/Positive percent agreement
- Reproducibility
- Limit of Detection (LOD)
- Limit of Quantitation (LOQ)
- Interference study
- Linearity study
- Accuracy analysis
- Shelf life
- ...
Requirement Confirmation
- Raw material screening
- Formulation development & stability testing
- Scale-up process optimization
- Intermediate customization & production
- Regulatory consultation & certification
- Commercial-scale manufacturing
Confirm cooperation and sign contract
- FTE (Full-Time Equivalent)
- Project development & management
- Strategic partnership
- Others
Project management and updates
- Establish project and develop plan
- Update project progress
- Jointly address challenges and provide solutions/next steps
Product delivery
- Deliver according to schedule
- Customer performance evaluation & validation
- Post-sale technical support