Alexandra Worobec, M.D.

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A Risk-Based Approach to Immunogenicity Concerns of Therapeutic Protein Products, Part 3: Effects of Manufacturing Changes in Immunogenicity and the Utility of Animal Immunogenicity Studies

Amy S. Rosenberg, MD;Alexandra Worobec, M.D.
January 1st 2005

Manufacturing changes - such as changes in formulation or source material - can impact a product’s immunogenicity.

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A Risk-Based Approach to Immunogenicity Concerns of Therapeutic Protein Products, Part 1: Considering Consequences of the Immune Response to a Protein

Amy S. Rosenberg, MD;Alexandra Worobec, M.D.
November 1st 2004

Neutralization of therapeutic protein products does not produce an obvious clinical deficiency syndrome for all therapeutic protein products with endogenous counterparts, because many endogenous proteins are biologically redundant.

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