cGMP TESTING SERVICES
WiCell’s cGMP cytogenetic testing services support the regenerative medicine community as projects transition from research to clinical applications and regulatory approval. Ensuring the identity, stability, and integrity of cell products is critical for compliance and patient safety. Our cGMP-compliant karyotyping assesses chromosomal stability, fluorescence in situ hybridization (FISH) detects structural abnormalities, and short tandem repeat (STR) analysis verifies cell line identity. These services are designed to meet regulatory submission requirements, helping you advance your therapies with confidence. Follow the links below to learn more about each of these services.
cGMP Karyotype
cGMP Fluorescence In Situ Hybridization (FISH)
cGMP Short Tandem Repeats (STR)
If you have a unique project, require specialized testing, or want to learn more about our cGMP and non-cGMP testing services, click the "Request Information" button to connect with our team.
WICELL SERVICE OPTIONS COMPARISON: cGMP / non-cGMP
Intended Use
cGMP Service: Recommended for translational and clinical product characterization. Use to verify the quality of cellular materials for inclusion in regulatory submissions.
non-cGMP Service: Recommended for research product characterization. Use for research and development and to familiarize your team with the service and results.
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
cGMP Service: Yes
non-cGMP Service: No
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
cGMP Service: Yes
non-cGMP Service: Yes
Supplier Qualification
cGMP Service: Yes
non-cGMP Service: Yes
Harvest Reagent Traceability
cGMP Service: Yes
non-cGMP Service: Yes
Harvest Batch Record
cGMP Service: Yes
non-cGMP Service: No
Quality Questionnaire (if requested)
cGMP Service: Yes
non-cGMP Service: Yes
In-Person Audit (if requested)
cGMP Service: Yes
non-cGMP Service: No
Quality Agreement (if requested)
cGMP Service: Yes
non-cGMP Service: No
Prospective Process Description
cGMP Service: Yes
non-cGMP Service: No
A process description allows for work to be customized by cell type, project, and is pre-approved by the client.
Method Qualification Available
cGMP Service: Yes
non-cGMP Service: No
American Society of Clinical Pathology (ASCP) Certified Analyst
cGMP Service: Yes
non-cGMP Service: No¹
¹ All WiCell karyotypes are analyzed by two analysts (at least one of whom is ASCP certified) and QC reviewed by a third analyst.
Deviations Reported
cGMP Service: Yes
non-cGMP Service: No
Publication Images (if requested)
cGMP Service: Yes
non-cGMP Service: Yes
Final Test Report
cGMP Service: Yes
non-cGMP Service: Yes
All final karyotypes are reviewed and signed by an ABMGG board certified or board-eligible director.
Final Test Report with QA Review
cGMP Service: Yes
non-cGMP Service: No
Certificate of Compliance
cGMP Service: Yes
non-cGMP Service: No
Data Package Available
cGMP Service: Yes
non-cGMP Service: No
Custom Report Writing Support Available
cGMP Service: Yes
non-cGMP Service: No
