Current regulatory requirements for testing for Particulates in Biological products

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Particulates in protein therapeutic products can arise from numerous sources and present a safety concern because they can increase the immunogenicity of the product.   Regulatory agencies therefore require sponsors to minimize particulates that are not intrinsic to the product.  Testing and characterization of particulates is a key to the overall product control strategy. 

Tests for particulates form a key part of the product specifications and is usually closely scrutinized during review of Protein Therapeutics regulatory applications.  This is because aggregates in protein products have the potential for increasing the immunogenicity of the product.  The risk of immunogenicity varies with the product and patient populations and risk of formation of immunogenic protein aggregates depends on the formulation.  Yet, the potential seriousness of an unwanted immune response makes it necessary to adopt a strategy to minimize the risk of particulate for all protein products.  Adopting the right characterization and QC test methods for visible and sub-visible particles is therefore necessary for all protein products. 

This updated webinar addresses recent discussions in the industry related to testing for sub-visible particulates in protein therapeutics injectables.  Recent FDA expectations for reporting data will be discussed.  Methods for characterization and routine testing of particulates, their advantages and limitations will be discussed.   

 Areas Covered in the Session:

·Why test for sub-visible particulates in protein therapeutics

· Current regulatory expectations for testing for particulates in protein therapeutics

· Commonly used 'work-horse' methods for particulates

· Characterization methods for particulates

Who will benefit: 

· R&D Laboratory personnel

· R&D Laboratory Supervisors and Management

· QC Laboratory personnel and management

· Protein Formulation Group personnel and Management

· Regulatory Affairs personnel

· Regulatory Affairs Management

· QC Laboratory personnel and management

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