Viral Clearance

BRC Viral Clearance Studies Platform has established a comprehensive quality management system in accordance with GLP standards and has successfully obtained EU GMP Qualified Person (QP) declaration. To date, the model viruses and indicator cells used in this platform are sourced from ATCC and have completed standardized bank construction. Currently, the viral clearance validation service line has the capability to provide viral clearance validation services that meet IND and BLA submission requirements.


Facility Environment:
GLP
EMA GMP QP
Platform Advantages:
30+ successful projects​ GLP Compliant with QP declaration Four dedicated virus clearance (VC) lines GMP Grade and QC-validated model viruses (ATCC-sourced) End-to-end regulatory support
Testing Capabilities:
  • 1.Viral Clearance Study
  • 2.Viral Clearance Validation for IND submission
  • 3.Viral Clearance Validation for BLA submission
  • 4.Risk Assessment
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