Alexandra Worobec, M.D.

home / authors / alexandra-worobec-md

Articles

i1-146216-1416913606357.jpg

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.

Site Logo

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.

Latest Updated Articles

Text sign showing Industry News. Business photo text delivering news to the general public or a target public | Image Credit: © Artur - © Artur - stock.adobe.com
Published: September 11th 2024 | Updated: September 18th 2024
CPHI Pharma Award Finalists Announced for 2024
Science laboratory test tubes, laboratory equipment | Image Credit: © BillionPhotos.com - © BillionPhotos.com - stock.adobe.com
Published: March 27th 2024 | Updated: June 28th 2024
AbbVie Acquires Landos Biopharma and Gets Full FDA Nod for ADC Product
Published: October 28th 2024 | Updated: November 24th 2024
Discovery to Commercialization: The Right Partnerships are Key to Streamlined Drug Development
Published: November 15th 2024 | Updated: November 24th 2024
Solving Challenges with AAV Aggregate Analysis Using a Novel Size Exclusion Particle to Determine CQAs
Published: October 28th 2024 | Updated: November 24th 2024
Cell-based phenotypic screening with Incucyte® Live-Cell Analysis Systems
Optimizing cGMP Facility Design Space with a Hybrid Approach
Published: October 22nd 2024 | Updated: November 24th 2024
Optimizing cGMP Facility Design Space with a Hybrid Approach
© 2024 MJH Life Sciences

All rights reserved.