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Mechanism and Factors Involved: Because of the many physical and chemical manipulations required in upstream production and downstream processing, followed by formulation and filling operations, aggregation of protein biopharmaceuticals can be induced during nearly every step of the process including at hold points, shipping, and long-term storage (16,21)

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Clostridium sensu stricto 1 Clostridium sensu stricto 1 represents a gut-associated clade of predominantly gram-positive, spore-forming, obligately anaerobic rods that typically persists at low relative abundance but can respond rapidly to ecological disturbance 135

Yoshimi R, Ueda A, Ozato K, Ishigatsubo Y