Use of MMV as a Single Worst-Case Model Virus in Viral Filter Validation Studies

Area of Science:

• Biopharmaceutical Process Development
• Viral Safety
• Filtration Technology

Background:

• Parvovirus filtration is critical for viral safety in biopharmaceutical manufacturing.
• Traditional viral clearance studies are data-intensive and conservative.
• Evolving trends favor streamlined, mechanism-based validation approaches.

Purpose of the Study:

• To present a concept for virus validation using a single, worst-case model parvovirus for parvovirus-grade filters.
• To provide a scientific rationale for using a single model virus in viral clearance studies.
• To support more efficient and streamlined viral clearance study designs.

Main Methods:

• Review of published literature on parvovirus filters and model viruses.
• Analysis of historical data from Amgen on virus clearance.
• Risk assessment for selecting relevant model viruses for clearance studies.
• Comparison of clearance capabilities for different viruses against mouse minute virus (MMV).

Main Results:

• Mouse minute virus (MMV) is supported as a worst-case model virus for parvovirus filters.
• Parvovirus filters utilize size exclusion mechanisms for virus removal.
• Data indicates MMV can effectively represent the clearance of larger viruses.

Conclusions:

• A single, worst-case model virus approach simplifies viral clearance studies.
• This streamlined validation enhances efficiency and reduces costs.
• The proposed approach strengthens the scientific basis for viral safety assurance.