Regulatory Perspective on Aggregates as a Product Quality Attribute

Aggregation of Therapeutic Proteins

Volumn , Issue , 2010, Pages 435-451

  Weinberg, Wendy C ^a   Ha, Linan ^a   Kirshner, Susan L ^a   Verthelyi, Daniela I ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

Aggregate formation control safety and efficacy of protein products; Product aggregates and safety concerns aggregates impact on product biodistribution; Regulatory perspective on aggregates as product quality attribute

Indexed keywords

EID: 80053028171     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.1002/9780470769829.ch11     Document Type: Chapter

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