New EFPIA Position Paper

on Next Generation Sequencing (NGS) for Adventitious Virus Detection 

The EFPIA (European Federation of Pharmaceutical Industries and Associations) has released a pivotal position paper on the use of Next Generation Sequencing (NGS) for adventitious virus detection in biological medicinal products.

This publication is the result of collaborative efforts from dedicated experts across the industry, including significant contributions from PathoQuest.

This insightful paper is crafted for scientists and regulatory specialists, offering comprehensive recommendations on analytical method validation, analytical comparability, and regulatory strategies.

Key Sections:

  • Analytical Method Validation: Detailed guidelines on validating NGS-based methods for virus detection.

  • Analytical Comparability: Insights into comparing NGS with conventional virus detection methods.

  • Regulatory Strategies: Comprehensive strategies to facilitate regulatory acceptance and global alignment.

 

Are you ready to fast-track your NGS implementation for a faster, safer, and animal free biotesting?