USP 1050 Viral Safety of Biotechnology Products Derived from Cell Lines of Human or Animal Origin - proposed Revision

In January 200, the United States Pharmacopeial Convention (USP) adapted the International Conference of Harmonization (ICH) Guideline about "Viral Safety Evaluation of  Biotechnological Products Derived from Cell Lines of Human or Animal Origin" as general chapter 1050. Since then, the USP published this guideline in all following volumes without any changes.

The progress in technologies and methods of viral testing and clearance now necessitates a revision of this general chapter.  The USP Council of Experts Vaccine and Virology Expert Committee proposed the following revisions:

  • Revised Section VI "Evaluation and Characterization of Viral Clearance Procedures" to provide a more practical approach to viral clearance studies
  • For a better illustration of the potential and most often used action points where viral clearance steps are necessary, they added flowcharts and diagrams
  • Tables with examples of model viruses and the glossary are updated
  • Referring to the development of the current practices of viral testing in a biological product life cycle, the added and deleted some passages

The target of the proposed changes is a better understanding of  the questions:

1. How viruses can enter the manufacturing process?

2. Which evaluation of  mammalian master cell banks and working cell banks should be useful to ensure that they are free of viruses?

3. How should intermediates and bulks be tested and for which viruses?

4. In which manner can a complete manufacturing process be evaluated to show that the downstream process has the capacity in each step to remove viruses.

The ECA Education Course "Virus and TSE Safety Made Simple" in Munich, Germany, from 22-23 September 2010 provides information about the regulatory background  and the particular challenges in detection, inactivation and removal of viruses in pharmaceutical products.

Axel H Schroeder
On behalf of the European Compliance Academy (ECA)

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