Rigorous Testing for Translational and Clinical Research
As your research progresses from the bench to clinical studies and ultimately to approved products, the need for more stringent testing becomes paramount. WiCell’s cGMP (Current Good Manufacturing Practice) services have been specifically designed to meet these rigorous demands, supporting the regenerative medicine community at every stage of development.
Our cGMP-compliant cell line characterization and cytogenetic services are crafted to ensure that your data can be submitted to regulatory bodies with confidence. This level of testing is essential for labs focusing on translational studies and clinical products, where the highest standards of accuracy, reliability, and compliance are required. With cGMP Karyotype, FISH (Fluorescence In Situ Hybridization), and STR (Short Tandem Repeat) testing, WiCell provides the quality assurance necessary to meet the strict regulatory requirements of clinical research.
Our highly-trained ASCP (American Society of Clinical Pathology) Certified Analysts and American Board of Medical Genetics and Genomics (ABMGG) board-certified or board-eligible directors bring years of experience in delivering timely and accurate results. This expertise is now available in a cGMP-compliant format, ensuring that your research is supported by the highest level of testing integrity as you move closer to clinical application.
cGMP Services Available
WiCell currently offers the following cGMP complaint services.
- G-Banded Karyotype: Our high-resolution G-banded karyotype analysis provides a detailed overview of chromosomal composition, delivering publication-ready results with the accuracy your research demands.
- Fluorescence In Situ Hybridization (FISH): WiCell’s FISH assays precisely localize specific DNA sequences on chromosomes, ideal for detecting targeted chromosomal abnormalities or aneusomies.
- Short Tandem Repeat Analysis (STR): Ensure the authenticity of your cell lines with STR analysis, which identifies and verifies the length of short, repetitive DNA sequences.
If you are unsure if your project requires the standard, non-cGMP services or is ready for cGMP-grade services, this comparison chart may help you decide.
In addition to these services, WiCell also offers a number of cGMP compliant cell lines to begin your research with. You can find out more information about those under the Clinical Grade (cGMP) Cell Banks page.
Why Choose WiCell
WiCell has a longstanding commitment to advancing the field of regenerative medicine. By offering these cGMP-compliant services, we continue to play a critical role in moving the field forward, helping researchers transition from foundational studies to impactful clinical outcomes. Whether you are preparing for regulatory submissions or ensuring the robustness of your translational studies, WiCell’s cGMP services provide the attention to detail and quality control your project demands.