Comparison of non-cGMP and cGMP services
When trying to decide if your project requires non-cGMP services or cGMP services, the following comparison can be helpful. WiCell staff are ready and willing to review the differences and discuss your particular project needs with you or your team. If you have any questions about which assay level is right for you, please contact us.
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WICELL SERVICE OPTIONS |
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Attributes |
non-cGMP Service |
cGMP Service |
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Intended Use |
Recommended for Research Product Characterization |
Recommended for Translational and Clinical Product Characterization |
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Use for research and development and to familiarize your team with the service and results. |
Used to verify the quality of cellular materials for inclusion in regulatory submissions. |
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Compliant with 21 CFR 211 |
No |
Yes |
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WiCell holds quality as our top priority. Our quality system consists of a dedicated Quality Assurance Team ensuring compliance, supplier management, and a robust training program. |
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Personalized Customer Technical Support |
Yes |
Yes |
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Supplier |
Yes |
Yes |
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Harvest Reagent |
Yes |
Yes |
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Harvest Batch Record |
No |
Yes |
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Quality Questionnaire |
Yes |
Yes |
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In-Person Audit |
No |
Yes |
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Quality Agreement |
No |
Yes |
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Prospective Process Description |
No |
Yes |
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A process description allows for work to be customized by cell type, project, and is pre-approved by the client. |
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Method Qualification Available |
No |
Yes |
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American Society of Clinical Pathology (ASCP) Certified Analyst |
No* |
Yes |
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*All WiCell karyotypes are analyzed by two analysts (at least one of whom is ASCP certified) and QC reviewed by a third analyst. |
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Deviations |
No |
Yes |
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Publication Images |
Yes |
Yes |
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Final Test Report |
Yes |
Yes |
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All final karyotypes are reviewed and signed by an American Board of Medical Genetics and Genomics (ABMGG) board certified or board eligible director. |
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Final Test Report with |
No |
Yes |
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Certificate of Compliance |
No |
Yes |
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Data Package Available |
No |
Yes |
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Custom Report Writing |
No |
Yes |