The Allele Biotech cGMP Quality Control (QC) Testing team is composed of experts dedicated to reprogramming and iPSC-related research and development since 2010. With Allele Biotech’s steadfast commitment to cGMP operation, this team has conducted testing on hundreds of iPSC lines in cGMP settings. This includes additional requirements such as equipment IQ OQ PQ, reagents change control, SOP establishment and conformance, data review tracking trending, and more.
We are now making these valuable resources accessible to the entire reprogramming and iPSC field. Our mission is to assist your team in systematically assessing your starting iPSC line using our validated cGMP-compliant testing methods. This ensures that your team can proceed with confidence, minimizing the risk of potentially abandoning the line and starting anew after investing tens to hundreds of millions of dollars in funding, and even more critically, wasting your precious time and opportunity to pioneer a complex cell therapy.
In addition to the reliability and consistency guaranteed by our cGMP-compliant operations, there is another invaluable advantage: testing your starting iPSC line at Allele Biotech. Leveraging Allele Biotech’s patented and robust mRNA-based reprogramming technology, we have established and qualified multiple internal reference iPSC lines. These lines have been rigorously evaluated and verified to remain stable over 100 passages of continuous culture. They serve as reliable controls for all our assays.
Quality Attributes we can test for you include but are not limited to:
- Sterility
- Mycoplasma
- Endotoxin
- Morphology Assessment
- Cell Viability
- Cell Quantitation
- Flow Cytometry Test for iPSC Specific Cell Surface Markers
- Karyotyping
- WGS and Associated Bioinformatic Analysis
- RNAseq and Associated Bioinformatic Analysis
- Ectoderm Differentiation Potential Analysis
- Mesoderm Differentiation Potential Analysis
- Endoderm Differentiation Potential Analysis
- Customized Differentiation Protocol Assessment
- Customized cGMP-Compliant Stability Study
If you are interested, please contact us via email at info@allelebiotech.com.