Quality Control
We understand the critical importance of maintaining the highest standards throughout the entire process, from receiving tissue samples to generating and expanding iPSCs and even during transportation if required. Our commitment to quality ensures that your iPSCs meet rigorous standards for safety, purity and efficacy.
Incoming tissue samples:
- Visual inspection: Upon receiving, tissue samples undergo through visual inspection to assess their integrity and quality
- Pathogen Screening Tests: All blood samples will be tested and confirmed negative for HIV-1, HIV-2, Hepatitis B, Hepatitis C, Treponema Palladium and CMV before process
- Morphological Confirmation: The cell morphology of the client’s starting material are visually inspected to ensure suitability for iPSC generation
Generation and Expansion of iPSCs:
- Vector Clearance Verification: We verify the vector clearance
- Sterility Testing: Selected sterility testing is conducted on client cell banks to confirm the absence of microbial contamination
- Genomic Integrity: Genomic integrity of iPSCs is assessed to detect any chromosomal abnormalities or mutations
- Pluripotency Assessment: The pluripotency of iPSC is evaluated to confirm their ability to differentiate into cells.
Transportation of Samples (if Required):
- Careful Handling: During transportation, every effort is made to ensure the safe and secure transit of samples to maintain their quality and viability
A set of quality metrics has been established to assess the attributes of the final products. QC SOPs and test records document the testing procedures and measured results. Where applicable, statistical analyses are performed, especially when multiple samples (technical or biological replicates) are collected.
- iPSC quality attributes:
- Sterility
- Endotoxin
- Mycoplasma
- Pluripotency marker expression by immunohistochemistry
- Pluripotency marker expression by flow cytometry
- Vector clearance
- Genomic integrity (Karyotyping)
- Cell morphology
- Cell count and viability
- MSC quality attributes
- Sterility
- Endotoxin
- Mycoplasma
- Attachment to plastic
- MSC marker expression by flow cytometry
- Potency test using trilineage differentiation
- Genomic integrity (Karyotyping)
- Cell morphology
- Cell count and viability
Accreditations
GMP Certificate
Clean Room Report
(Enumeration of total bacterial count from swab samples)
Clean Room Report
(Microbial Air Monitoring Report )
