Viral Testing and Clearance Studies

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Ensuring viral safety is a critical requirement in biopharmaceutical development. Our platform conducts regulatory-compliant viral safety evaluations using validated model viruses to demonstrate product integrity, process robustness, and compliance with international guidelines (ICH, FDA, EMA).

Viral Clearance Validation & Disinfectant Validations

We perform rigorous viral clearance studies to confirm the effectiveness of purification and inactivation steps:

• Spiking Studies Across Upstream & Downstream Processes

  Model viruses are introduced into production streams to evaluate clearance efficiency at each stage.

• Evaluation of Filtration, Chromatography & Inactivation Steps

  Comprehensive testing of process steps to validate viral removal and inactivation capacity.

• Disinfectant Validations

  Assess the effectiveness of cleaning agents and sanitization procedures against viral contaminants.

Adventitious Agent Testing

• Detection of Contaminating Viruses

  Sensitive assays to identify unexpected viral contaminants in cell banks, raw materials, and final products.

• Regulatory Alignment

  Meets global requirements for adventitious agent testing to ensure product safety and compliance.

Infectivity Assays

We provide multiple validated methods to measure viral infectivity:

• TCID50 (Median Tissue Culture Infectious Dose)

  Quantifies viral particles capable of infecting cells.

• Plaque Assays

  Visualizes and counts viral plaques to determine viral titers.

• Endpoint Dilution Assays

  Measures viral infectivity through serial dilution and statistical analysis.

Residual Viral Nucleic Acid Quantification

• qPCR-Based Detection of Viral DNA/RNA

  Highly sensitive assays to detect and quantify residual viral genetic material.

• Process Validation

  Confirms the effectiveness of purification steps in reducing viral nucleic acids to acceptable levels.

• Risk Mitigation

  Provides assurance that products are free from residual viral genomes that could compromise safety.