Yeasen Molecular IVD RDC Accelerating the IVD Products Development
Yeasen Biotechnololgy RDC (Research and Development Contracting) team is dedicated to provide total solutions to meet the diverse application needs of molecular IVD customers including enzyme selection, primer and probe design, reaction buffer optimizing, product validation, sensitivity analysis, specificity analysis, precision studies, stability studies, SNP evaluation, instrument application evaluation.and so on to accelerate the progress of product development.
Customer Benefits
- Product quality Promising
- Time Benefit
- Cost Benefit
- Registration file support
- Continuous and stable supply of raw materials
Why Yeasen can offer the IVD RDC services ?
- ISO 13485 certified ultra-clean molecular enzyme (UCF.ME) production facility.
- Technology platform for PCR, LAMP and Lyophilization.
- RDC Team consists of multiple experts on enzyme engineering, purification, primer design et. al.
- 10-years experience of reagent manufacturing.
Case studies:
Yeasen maintains a comprehensive library of over 100 Taq polymerase antibodies, enabling tailored screening and matching for various Taq enzymes. A customer required antibodies capable of effectively inhibiting a Taq enzyme mutant with 95% efficiency while maintaining stability for 7 days at 37°C without performance degradation. From this library, Yeasen identified two suitable candidates: #301 polymerase-blocking antibody and #2 exonuclease-blocking antibody. Combined, these antibodies met the customer’s specifications and were successfully delivered.
After multiple unsuccessful attempts at product development, the client turned to Yeasen for a solution. Yeasen conducted a preliminary screening from its enzyme library and provided two Taq enzyme samples for testing. After thorough testing and validation, the client confirmed the performance met their requirements. The new enzyme was then successfully scaled up for production at the UCF.ME facility, ensuring a stable and continuous supply.
Work flow of RDC:
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Define project objectives, discuss technical strategies
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Contract signing and project kickoff
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Project initiation and weekly progress updates
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Final project review and reporting
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Core material concentration
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Sensitivity validation data
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Limit of detection (LOD) validation data
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Specific instrument validation data
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Competitor comparison data
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Stability validation data
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Validation data before and after lyophilization
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Transfer of technical documentation