GMP 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 karyotype service available in a cGMP-Complaint Karyotype fashion to enable submission to regulatory bodies. 

cGMP-compliant FISH testing will be available soon!


WICELL SERVICE OPTIONS

Attributes

Research Grade Service 

cGMP Service 

Intended Use 

Recommended for Research Product Characterization 

Recommended for Translational and Clinical Product Characterization 

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. 

Compliant with 21 CFR 211

No

Yes

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.  

Personalized Customer Technical Support 

Yes 

Yes 

Supplier Qualification 

Yes 

Yes 

Harvest Reagent Traceability 

Yes 

Yes 

Harvest Batch Record

No 

Yes 

Quality Questionnaire 
(if requested)

 Yes 

Yes 

In-Person Audit
(if requested)

No 

Yes  

Quality Agreement 
(if requested)

No 

Yes 

Prospective Process Description

No 

Yes  

A process description allows for work to be customized by cell type, project, and is pre-approved by the client. 

Method Qualification Available 

No 

Yes 

American Society of Clinical Pathology (ASCP) Certified Analyst 

 No

Yes 

1All WiCell karyotypes are analyzed by two analysts (at least one of whom is ASCP certified) and QC reviewed by a third analyst. 

Deviations Reported 

No 

Yes 

Publication Images
(if requested)

 Yes 

Yes 

Final Test Report

 Yes 

Yes 

All final karyotypes are reviewed and signed by an American Board of Medical Genetics and Genomics (ABMGG) board certified or board-eligible director. 

Final Test Report with QA Review 

No 

Yes 

Certificate of Compliance 

No 

Yes 

Data Package Available 

No 

Yes 

Custom Report Writing Support Available

 No  

Yes