Evaluation of Virus Safety in Biopharmaceuticals Based on ICH Q5A(R2): Utilization of Next-Generation Sequencing (NGS) and Regulatory Submission

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English catalog entry for a Japanese market intelligence report by Science & Technology. Publication date: 2026-06-26. This page is an original catalog description, not a full translation of the Japanese edition.

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Description

This is a request, not an immediate purchase. Delivery takes about one week. Your card is authorized but not charged until the English PDF is ready.

Product ID: 1181

Publisher: Science & Technology

Publication Date: 2026-06-26

English Summary

English catalog entry for a Japanese market intelligence report by Science & Technology. Publication date: 2026-06-26. This page is an original catalog description, not a full translation of the Japanese edition.

Contents / Coverage

  • Chapter 1: Intent and Key Points of ICH Q5A(R2): Revision of Virus Safety Evaluation for Biopharmaceuticals
  • Chapter 2: Setting Test Items and Characterization for Exogenous Infectious Substances in Cell Banks
  • Chapter 3: Safety Evaluation and Assurance in Raw Material Management
  • Chapter 4: Principles of Virus Clearance Testing, Selection of Evaluation Processes, and Test Design
  • Chapter 5: Experimental and Evaluation Methods for Virus Clearance Testing
  • Chapter 6: Utilization of Next-Generation Sequencing (NGS) in Virus Safety Management
  • Chapter 7: Validation of Analytical Methods for Next-Generation Sequencing (NGS) Testing and Considerations for Regulatory Submission
  • Chapter 8: Considerations for Virus Safety Evaluation Unique to Continuous Production
  • Chapter 9: Virus Clearance of Recombinant Viral Vectors
  • Chapter 10: Utilization of Prior Knowledge: Streamlining Virus Clearance Testing

Why This May Matter Internationally

This publication addresses the critical aspects of virus safety evaluation in biopharmaceuticals, particularly in the context of international regulatory standards such as ICH Q5A(R2). It highlights the integration of next-generation sequencing (NGS) in ensuring the safety and efficacy of biopharmaceutical products, making it relevant for global stakeholders in the pharmaceutical and biotechnology industries.

Keywords: Japan,technical book,Science & Technology

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