Particulates in Biological products - Why test them and what are the new reporting requirements (Biotech)
Venue: Online Event
|Event Date/Time: May 24, 2011||End Date/Time: May 24, 2011|
Particulates in Biologics injectibles can arise from the aggregation of the protein product. It has been suggested that the aggregated material presents a safety concern because it increases the possibility of formation of anti drug antibodies. The FDA has therefore requested BLA sponsors to present sub-visible particulate data at the clinical and commercial stage and has identified the 0.2 - 10 micron as a range where there is a lack of suitable techniques for testing particles. Whether the aggregates in protein therapeutics truly increase the immunogenicity of the product is not completely clear and continues to be debated in the industry. Nevertheless this debate has increased the scrutiny of reviewers on the testing and reporting of particulates in Protein Therapeutics.
This webinar addresses recent discussions in the industry related to testing sub-visible particulates in Biologics injectibles. Recent FDA expectations for reporting data will be discussed. Methods for characterization and routine testing of particulates, their advantages and limitations will be discussed. Case studies where the various methods have been used for characterization of the sub-visible particles will be discussed.
Areas Covered in the Seminar:
Why test for sub-visible particulates in protein therapeutics.
Current expectations for testing for particulates in protein therapeutics.
USP method for particulate testing in injectibles.
Commonly used 'work-horse' methods for particulates: SEC and SDS-PAGE.
AUC and FFF.
Light scatter methods.
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