Leveraging Risk Assessment for Demonstrating Product Comparability after Manufacturing Process Changes

In this latest article, Dr. Xuemei Han, Director of Analytical Development at Tanvex CDMO, explores the intricacies of comparability assessments for biologics, highlighting Tanvex’s innovative approach to maintaining product integrity through:

 

  • Strategic Risk-Based Assessments: Tailored strategies for ensuring regulatory compliance and product quality.
  • Advanced Analytical Techniques: Cutting-edge technologies for comprehensive comparability assessments.
  • Demonstrated Expertise: Extensive experience in managing process changes and maintaining product efficacy.

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