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Considerations in performing virus spiking experiments and process validation studies

A J Darling1

  • 1Quality Biotech Ltd., Glasgow, UK.

Developments in Biological Standardization
|January 1, 1993
PubMed
Summary
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Ensuring virus safety in blood and plasma products requires robust manufacturing processes. Measuring viral clearance capacity is essential to guarantee product safety and prevent infectious virus contamination.

Area of Science:

  • Biotechnology
  • Virology
  • Product Safety

Background:

  • Industrial-scale production of blood and plasma products relies on effective virus removal and inactivation procedures.
  • Variability in starting materials necessitates rigorous assessment of manufacturing processes for virus safety.

Purpose of the Study:

  • To emphasize the critical need for measuring viral clearance capacity in blood and plasma production.
  • To ensure a high degree of assurance against infectious virus contamination in final products.

Main Methods:

  • Process validation for viral clearance.
  • Assessing the capacity of production processes to remove or inactivate viruses.
  • Quality control in biopharmaceutical manufacturing.

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Main Results:

  • The study highlights the indispensable role of viral clearance capacity measurement.
  • Consistent and reliable methods are crucial for validating the safety of blood and plasma products.

Conclusions:

  • Measuring viral clearance is paramount for ensuring the safety of industrially produced blood and plasma products.
  • A thorough understanding and measurement of viral clearance capacity provide assurance against virus contamination.