Sub-visible Particulates in Biological products 2016

Topics

• USP method for particulate testing in injectable
• Regulatory expectations for testing for sub-visible particulates in protein therapeutics
• Characterization methods for particulates
• Commonly used `work-horse` methods for particulates
• Newly emerging methods for sub-visible particulates
• Limitations of the various methods

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