cGMP TESTING SERVICES
WiCell's cGMP services have been designed to address the needs of the regenerative medicine community as projects move from the bench to clinical studies and approved product. WiCell has supported the community during years of research and we have helped to move the field forward. We are very happy to announce that we have made our karyotyping and fluorescence in situ hybridization (FISH) services available in a fashion to enable submission to regulatory bodies. Follow the links below to learn more about each of these services.
cGMP Karyotype
cGMP Fluorescence In Situ Hybridization (FISH)
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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 the U.S. FDA Current Good Manufacturing Practice for Finished Pharmaceuticals (21 CFR part 211) and the EU Good Manufacturing Practice guidelines (EC EudraLex Volume 4) where applicable |
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
Qualification |
Yes |
Yes |
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Harvest Reagent
Traceability |
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 |
No1 |
Yes |
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1All 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
Reported |
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
QA Review |
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
Support Available |
No |
Yes |
