Allele maintains an expanding portfolio of cGMP-validated quality control tests to support iPSC-based cell therapy products. These tests are applied to raw materials, in-process materials, and final products and are performed within an established Quality Management System to ensure compliance with regulatory requirements and consistent product quality.
Our quality control capabilities include testing for sterility, mycoplasma, endotoxin, donor identity, cell quantitation and viability, biomarkers, potency, as well as genetic and epigenetic analysis. Testing activities are conducted using qualified methods and controlled procedures and are integrated with manufacturing operations to support product release and process oversight.
Quality control results are documented and reviewed as part of formal quality assurance processes. Manufacturing runs are conducted under defined protocols and Master Batch Records, followed by quality review prior to product release. Quality events are managed through impact assessment and root-cause analysis, with escalation to corrective and preventive actions when necessary.
In addition to routine testing, periodic reviews, internal audits, and preventive programs are conducted to maintain system integrity and ongoing compliance.
Quality Control Testing Coverage
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- Sterility testing
- Mycoplasma testing
- Endotoxin testing
- Donor identity confirmation
- Cell quantitation and viability
- Biomarker analysis
- Potency assays
- Genetic analysis
- Epigenetic analysis
If you are interested, please contact us via email at info@allelebiotech.com.
