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Contract Quality Testing
Tests
Sterility Testing
This is the final procedure for testing finished products for microbial contamination.
It includes testing the suitability of the test method and improving the accuracy and reliability of sterility testing.
- Direct inoculation method
- Membrane filtration method
- Rapid microbial detection method
Endotoxin Testing
Detects endotoxins, a component of lipopolysaccharides found in Gram-negative bacteria.
Checks for endotoxin contamination in cell and gene therapy manufacturing processes or in various culture media used in operations.
- Chromogenic (colorimetric) method
Mycoplasma Contamination Testing
Identifies the presence of Mycoplasma bacteria that may be contaminated by animal raw materials, media, or manufacturing environments used in the cell culture process.Includes testing for activation and growth conditions of mycoplasma strains via the Mycoplasma Culture Inhibition Activation Test.
- Direct culture method
- Rapid nucleic acid amplification (PCR) method
In-vitro adventitious virus testing
Determines whether adventitious viruses introduced from animal-derived substances, such as raw media used during the cell and gene therapy manufacturing process, have contaminated the final product (Performed as a 28-day cell culture test)
- Cytopathic effect (CPE) assay
- Hemagglutination Assay
- Hemadsorption Assay
Mixed Lymphocyte Reaction (MLR) Assay
Evaluates the immunologic compatibility and safety of cell therapy products using a T-cell activation model involving interaction between donor and recipient materials.
Viral Vector Analysis Test
This test quantitatively analyzes the titer and process-related impurities of gene therapy products to verify the consistency of biopharmaceutical production and evaluate their safety.
Titer Measurement Test
This test measures the titer of gene therapy products to ensure the consistency of biopharmaceutical production.
- Virus Particle Titer
- Virus Genome Titer
- Functional Titer
Residual Impurity Analysis Test
Determines whether adventitious viruses introduced from animal-derived substances, such as raw media used during the cell and gene therapy manufacturing process, have contaminated the final product (Performed as a 28-day cell culture test)
- Residual Host Cell Protein
- Residual Host Cell DNA
- Residual Nuclease
- Residual Plasmid DNA
Test Method Validation
Quantitative analysis of process-related impurities in gene therapy products to evaluate stability.
- Mycoplasma contamination test (nucleic acid amplification method)
- Residual impurity analysis test (antibiotics)
- Identity and purity testing
- Potency testing