Particulates in Biological Products - Evolving Regulations for Testing in Clinical and Commercial Stages 2018

Topics

• Current expectations for testing for particulates in protein therapeutics
• Why test for sub-visible particulates in protein therapeutics
• Commonly used `work-horse` methods for particulates
• USP method for particulate testing in injectibles
• Newly emerging methods for subvisible particulates
• Characterization methods for particulates

Who should Attend

• R&D Laboratory Supervisors and Management
• R&D Laboratory personnel
• Protein Formulation Group personnel and Management
• QC Laboratory personnel and management
• Regulatory Affairs Management
• Regulatory Affairs personnel
• QC Laboratory personnel and management