Evia Bio Cryo-Engineering Services
Risk
Assessment
Risk
Mitigation
Annual
Audit
CryoGAP Complete Risk Assessment
An assessment of Gaps and Risk Factors of entire cryopreservation process, including all four key areas described below.
Preparation & Formulation
- Pre-harvest & harvest factors impacting cryo
- Formulation (homebrew, commercial, or combination)
- Formulation characterization and quality assessment
- Containers and labels
- Introduction method, batch size, and timing
Freezing
- Infrastructure and equipment
- Freezing approach (passive or controlled) and protocol, including nucleation strategy
- Temperature mapping
- Uniformity and consistency
- Troubleshooting problems
Storage & Transportation Processes
- Transfer to and from storage
- Temperature monitoring and mapping
- Sample storage management
- Transient warming
- Best practices and personnel safety
Thawing & Post-Thaw Assessment
- Equipment
- Thawing protocol
- Sample handling
- Best practices and personnel safety
- Post-thaw processing, assessment, and release criteria
CryoGAP Select Risk Assessment
Assessment of Gaps and Risk Factors for individual risk categories (any of the four listed above).
CryoGAP Risk Mitigation
A CryoGAP plan to mitigate risks identified from CryoGAP assessment and optimize cell health. Assistance from the Evia Bio scientific team will be scoped and defined with a Statement of Work (SOW).
CryoGAP Annual Audit
Maintenance of Cryo excellence – Seal of Quality (Protocol Adherence; Troubleshooting issues)
Work with the Evia Bio team on a biweekly basis to improve and refine cryopreservation processes.
Cryo-Engineering Custom Development
A comprehensive approach to customizing formulations for cell-specific requirements, including:
- Formulation development
- Cryopreservation protocol development
- Extensive temperature and load mapping (scale up and technology transfer)
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