Articles by Amy S. Rosenberg, MD

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

Jan 1, 2005
By: Amy S. Rosenberg, MD, Alexandra Worobec, M.D.

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

A Risk-Based Approach to Immunogenicity Concerns of Therapeutic Protein Products, Part 2: Considering Host-Specific and Product-Specific Factors Impacting Immunogenicity

For protein therapeutics, immunogenicity testing should be conducted from the earliest stages of product development.
Dec 1, 2004
By: Amy S. Rosenberg, MD, Alexandra Worobec, M.D.

Immune responses to foreign proteins are expected and may be anticipated for some self-proteins. The rapidity of development and the strength and persistence of the response depends on many factors.

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

For protein therapeutics, immunogenicity testing should be conducted from the earliest stages of product development .
Nov 1, 2004
By: Alexandra Worobec, M.D., Amy S. Rosenberg, MD

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.