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Analysis of Virus Clearance for Biotechnology Manufacturing Processes from Early to Late Phase Development
Opeyemi O Ajayi1, Jackie L Cullinan2, Innara Basria2
1Center for Drug Evaluation and Research (CDER), Office of Pharmaceutical Quality (OPQ), Office of Product Quality Assessment III (OPQA III), Division of Product Quality Assessment XIV (DPQA XIV).
PDA Journal of Pharmaceutical Science and Technology
|April 29, 2025
Summary
Ensuring viral safety in biotechnology products requires robust virus clearance during manufacturing. Data shows chemical inactivation effectively removes retroviruses, while filtration removes parvoviruses, ensuring product safety.
Area of Science:
- Biotechnology
- Pharmaceutical Manufacturing
- Viral Safety
Background:
- Mammalian cell lines are used to produce biotechnology products like monoclonal antibodies.
- Virus contamination poses a significant safety risk that must be managed throughout product development.
- Regulatory agencies require rigorous virus clearance studies to ensure product safety.
Purpose of the Study:
- To analyze the impact of process changes on virus clearance in biotechnology drug products.
- To update the understanding of virus clearance based on long-term data from regulatory submissions.
- To evaluate the effectiveness of different unit operations in removing viruses.
Main Methods:
- Analysis of a comprehensive virus clearance database from FDA investigational new drug (IND) submissions (1986-2024).
- Evaluation of virus clearance data related to process changes during product development.
- Investigation of interactive process parameter effects on virus clearance for chromatography steps.
Main Results:
- Consistent and robust removal of retroviruses via chemical inactivation.
- Effective removal of parvoviruses using virus-retentive filtration.
- Chromatography unit operations provide additional virus removal capabilities.
- Process and product-specific factors significantly influence overall virus clearance efficacy.
Conclusions:
- Chemical inactivation and virus-retentive filtration are critical for mitigating viral safety risks.
- Chromatography plays a vital role in enhancing virus removal.
- Case-by-case evaluation of process and product attributes is essential for achieving reliable virus clearance in mammalian cell-derived products.
Keywords:
Chromatography Viral ClearanceLow pH inactivationPharmaceutical Viral ClearanceRetrovirus-Like Particle ClearanceSafety FactorViral SafetyVirus ClearanceVirus-Retentive FiltrationMore Related Videos
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