FDA Guidance for Industry: Potency Assay Considerations for Monoclonal Antibodies and Other Therapeutic Proteins Targeting Viral Pathogens
Title:
FDA Guidance for Industry: Potency Assay Considerations
for Monoclonal Antibodies and Other Therapeutic Proteins Targeting Viral Pathogens
Origin/Publisher:
FDA
Content:
The purpose of this guidance is to provide to sponsors recommendations that assist in the development of monoclonal antibodies (mAbs) and other therapeutic proteins that directly
target viral proteins or host cell proteins mediating pathogenic mechanisms of infection.