“We’ve looked at every angle that CRISPR is being used by researchers and sought ways to make that process better, more efficient, and safer."
Mark Behlke, MD, PhD
Chief Scientific Officer
IDT
| Research (RUO) | Engineering Run | cGMP | ||
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| Compliance | ISO 9001-2015 |  |
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| ICH Q7 for pre-clinical and early phase clinical trail material | |
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| Quality Control | Basic characterization tests* | |
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| Qualified Testing Methods | |
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| Quality Control Testing* | |
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| Out-of-Specification Investigation | |
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| Customized Part Number with Customized Final Specification | |
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| Certificates | Certificate of Testing | |
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| Certificate of Origin (TSE/BSE Certificate) | |
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| Batch Record | Traceable | |
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| Custom | |
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| QA Review and Release | |
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| Raw Materials | Traceable | |
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| Inspection and Release # | |
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| Environment | Temperature and Humidity Controls | |
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| ISO Class 8 Clean Rooms | |
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| Environmental Monitoring | |
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| Dedicated Laboratory Suite During Manufacturing | |
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| Additionals | Regulatory support | |
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cGMP24-3170_001
