Particulates in Biological products. Why test them and what are the new reporting requirements
(www.complianceonline.com)
The FDA has requested BLA sponsors to submit sub-visible particulate data for Well Characterized Protein Products in the clinical and commercial phases.Why Should You Attend:
Proteinaceous Particulates in Biologics injectibles can arise from the aggregation of the protein product and can be induced by silicone droplets, metal particles and glass particles.
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- xiomarapaswater
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