Raw & Auxiliary Materials
Full characterization and safety testing for excipients, reagents, and ancillary materials used in CGT manufacturing.
Physicochemical Tests
- Appearance / Description
- Identification
- Melting Point
- Loss on Drying
- Clarity & Color of Solution
- Relative Density
- Refractive Index
- Aldehydes & Reducing Substances
- Water Content (KF)
- Osmolality
- Particulate Matter
Residuals & Impurities
- Related Substances
- Chlorides, Iodides, Bromides
- Residue on Ignition
- Iron Salts, Ammonium Salts
- Calcium, Barium, Potassium
- Nickel, Arsenic, Magnesium
- Sulfates, Nitrites, Phosphates
- Ferrocyanides, Heavy Metals
- Sugars, Fatty Acids & Lipids
- Readily Carbonizable Substances
- Chlorinated Compounds
Microbiological & Viral Safety
- Sterility Testing
- Bacterial Endotoxins (LAL)
- Mycoplasma Detection
- Microbial Limits (Bioburden)
- Assay (Content/Potency)
- Cell Proliferation Assay
- Human-derived Virus Testing
- Bovine-derived Virus Testing
- Porcine-derived Virus Testing
- Immunogenicity Assessment
Packaging Materials
Compatibility, integrity and safety evaluation for primary containers and closure systems.
Physicochemical & Dimensional
- Appearance & Visible Particles
- Dimensional Specs (OD, ID, thickness)
- pH of Aqueous Extract
- Particulate Matter
Functional Performance
- Heat Resistance
- Sterilization Resistance
- Freeze-thaw Compatibility
- Mating / Assembly Performance
Safety & Integrity
- Foam Test
- Cytotoxicity Test
- Hemolysis Test
- Microbial Challenge Test
- Sterility, Endotoxin, Mycoplasma
Cell Banks (MCB & WCB)
Comprehensive characterization and safety testing for master and working cell banks.
Cell Identity
- Flow Cytometry (immunophenotyping)
- Chromosome Karyotyping
Microbial Safety
- Sterility
- Endotoxin
- Mycoplasma
- Mycobacterium Testing
Viral Safety
- Adventitious Virus Agents (In Vitro & In Vivo)
- Retrovirus Testing
- Human-derived Virus
- Bovine-derived Virus
- Porcine-derived Virus
Tumorigenicity
- Tumorigenicity Testing (in vivo)
Recombinant Engineered Bacteria Strains & Related Products
Quality control for bacterial cell banks, plasmids, and recombinant products.
Strain & Product Characterization
- Culture Characteristics
- Colony Morphology & Size
- Gram Staining Microscopy
- Antibiotic Resistance
- Biochemical Reactions
- Culture Purity
- Target Product Expression Level
- Target Gene Sequencing
- Identity of Target Product
- Plasmid Restriction Map
- Plasmid Retention Rate
Recombinant Engineered Virus Seeds & Related Products
Safety and potency testing for viral vectors (AAV, LV, ADV) and virus banks.
Virus Seed Testing
- Target Gene Sequencing
- Virus Titer Determination
- Target Protein Expression Level
- Bacterial & Fungal Sterility
- Mycobacterium Testing
- Mycoplasma Detection
- Adventitious Virus Agents
Cell-based Drug Products
Release and stability testing for autologous/allogeneic cell therapies, CAR-T, MSC, and other advanced products.
Physicochemical Attributes
- Appearance
- Visible Particles
- Osmolality
- pH
- Moisture (if applicable)
- Subvisible Particulates
- Fill Volume / Net Content
Safety & Sterility
- Sterility
- Endotoxin
- Mycoplasma
- Human-specific Viruses
- Infectious Disease Screening
- Hematoplasma (Mycoplasma) Screening
- Abnormal Toxicity
Process-Related Residuals
- EGF Residual
- Lysis Buffer Residual
- Microcarrier Degradation Residuals
- AAV Residual
- Host Cell Protein (HCP)
- Host Cell DNA
- Bovine Serum Albumin (BSA)
- Nuclease Residual
- Lysozyme Residual
- Antibiotic Residual
- Bacterial Protein & DNA/RNA Residuals
Potency & Bioactivity
- Infectivity Titer
- Expression Activity (Transgene)
- Biological Activity (potency)
- Cytotoxicity / Killing Function