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!


Research vs. cGMP Comparison

  Research cGMP
Intended Use  

Our research characterization testing services are used in preclinical work. It can be used for Research
and development and to familiarize yourself with the service and the results. 
 

Our cGMP-compliant testing used in translational and
clinical product work. It can be used to verify the quality
of cellular materials and for inclusion in regulatory
submissions. 
Process and Validation
  • Standard Operating Protocols





  • Standard Operating Protocols
  • Audits (available both in-person and virtually) 
  • Prospective protocols customized for cell type, project, and pre-approved by client. 
  • Method Qualification
 
Training and Qualifications 
  • ASCP (American Society of Clinical Pathology) Certified/Highly-Trained Analysts
  • American Board of Medical Genetics and Genomics (ABMGG) board certified or board-eligible directors



  • ASCP (American Society of Clinical Pathology) Certified Analysts
  • American Board of Medical Genetics and Genomics (ABMGG) board certified or board-eligible directors  


Materials Used 
  • Traceable Critical Reagents 
  • Calibrated Equipment



  • Fully Traceable Critical Reagents
  • Calibrated Equipment
  • Documentation is specific to each sample preparation.   

Quality Systems Included
  • Document Control 
  • Complete Equipment Record Keeping 
  • Critical Reagent Qualification 
  • Audit Program 
  • Training Program 
  • QA Reviewed Protocols 



  • Document Control 
  • Complete Equipment Record Keeping 
  • Critical Reagent Qualification 
  • Audit Program 
  • Training Program 
  • QA Reviewed Protocols 
  • QA Reviewed Final Reports
  • Deviations reported 

 Reporting

  • Final Report 







  • Final Report
  • Certificate of Compliance 
  • Custom Report Writing Support (if requested)
  • Batch Record Documentation (if requested)