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Qualification of a novel inline spiking method for virus filter validation.

Herbert Lutz1, Wayne Chang, Tamas Blandl

  • 1EMD Millipore, 6220 Pacific Ave., #103, Playa del Rey, CA 90293, USA. Herb_lutz@millipore.com

Biotechnology Progress
|September 30, 2010
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Summary

A new inline spiking method enables accurate virus filter testing with prefiltration, improving throughput and reliability in biopharmaceutical manufacturing. This approach overcomes challenges posed by prefiltration removing viruses during standard testing procedures.

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Area of Science:

  • Bioprocessing
  • Filtration technology
  • Viral safety

Background:

  • Virus filters are crucial in bioprocessing for therapeutic safety.
  • Prefiltration is often needed but can interfere with virus removal testing.
  • Batch prefiltration can cause plugging and reduce throughput.

Purpose of the Study:

  • To develop and validate a novel inline spiking method for virus filter testing.
  • To enable accurate measurement of virus filter removal capabilities with inline prefiltration.
  • To address limitations of traditional batch prefiltration methods.

Main Methods:

  • Development of a novel inline spiking apparatus and procedure.
  • Testing the method with various protein feeds, parvovirus filters, and virus spikes (bacteriophage, MMV, xMuLV).
  • Comparison of inline vs. batch prefiltration for throughput and LRV measurement.

Main Results:

  • The inline spiking method reliably measures virus filter log reduction value (LRV).
  • Achieved throughputs are representative of manufacturing processes.
  • Overcame issues of prefiltration removing viruses and causing plugging.

Conclusions:

  • The novel inline spiking method is recommended for bioprocessing applications requiring prefiltration.
  • It enhances throughput and accurately measures virus filter performance.
  • Suitable for scenarios where prefiltration impacts virus titer or filter throughput.