Manufacturing changes - such as changes in formulation or source material - can impact a product’s immunogenicity.
Alexandra Worobec, M.D.
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Articles by Alexandra Worobec, M.D.
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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- A Risk-Based Approach to Immunogenicity Concerns of Therapeutic Protein Products, Part 1: Considering Consequences of the Immune Response to a Protein
Published: November 1st 2004 | Updated:
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