FDA-Meeting About Follow-on Protein Products

GMP News No. 479

GMP News
14 October 2004
 

FDA-Meeting about Follow-on Protein Products

 
On September 14-15, 2004 the FDA held a public workshop on Scientific Considerations Related to Developing Follow-On Protein Products. The purpose of this meeting was that the agency solicit the scientific and technological perspectives of manufacturers, academia, and other interested persons to determine the state of the science as it relates to protein characterization, production, and assessment of similarity.

The information gained during the workshop will have an impact on the agency's activities in developing a draft guidance on this topic during the coming year.

FDA uses the term "follow-on protein product" for a protein that is intended to be a similar version or copy of an already approved or licensed protein pharmaceutical product. Such proteins might be produced through biotechnology or derived from natural sources.

This is a different definition compared to "second-generation protein products" which are products that are similar to an already approved or licensed product but which have been deliberately modified to change one or more of the product's characteristics (e.g., to provide more favourable pharmacokinetic parameters or to decrease immunogenicity).

Although, this public workshop was not intended to address legal or regulatory issues, the presented information will influence FDA's opinion about regulatory issues concerning protein products.

Therefore, the workshop results are of high interest for all who are working in the field of protein characterization, production, and regulatory affairs.

Most of the workshop presentations can be downloaded here
 

On 4-5 November 2004 the European Compliance Academy (ECA) and the University of Applied Sciences Mannheim are organising a conference about Quality Control of Proteins in Frankfurt, Germany. During this event, recent developments on fundamental assays will be presented. Here you will find the comprehensive programme.

 
Author:
Dr Ulrich Herber
CONCEPT HEIDELBERG
  

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