Cell Bank Characterization Services

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Cell banks form the foundation of biologics manufacturing, and their integrity is critical for ensuring product safety, consistency, and regulatory compliance. Our cell bank characterization services provide comprehensive testing to confirm identity, purity, and genetic stability, while detecting potential contaminants that could compromise biopharmaceutical production.

Identity Testing

• Cell Line Authentication

  Verification of cell line origin using molecular markers and sequencing

• Species-Specific PCR Assays

  Confirm species identity and rule out cross-contamination.

• Isoenzyme Analysis

  Biochemical profiling to validate cell line authenticity

Purity & Contamination Control

• Mycoplasma Detection (qPCR, Culture-Based)

  Sensitive assays to ensure cell banks are free from hidden microbial contaminants.

• Adventitious Agent Testing

  Screening for unexpected viral, bacterial, or fungal contaminants.

• Sterility Testing

  Validated methods to confirm absence of microbial growth in cell banks.

Genetic Stability & Integrity

• Karyotyping & Chromosomal Analysis

  Detects structural or numerical chromosomal abnormalities.

• Copy Number Variation & Gene Expression Profiling

  Confirms genetic consistency across passages.

• Long-Term Stability Studies

  Monitoring of production cell lines to ensure reliable performance over time.

Viral Safety Testing

• Residual Viral Nucleic Acid Detection (qPCR)

  Ensures absence of viral DNA/RNA in cell banks.

• Infectivity Assays (TCID50, Plaque Assays)

  Validates that cell banks are free from infectious viral particles.