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Follow-on protein products: scientific issues, developments and challenges

Paper ID Volume ID Publish Year Pages File Format Full-Text
37256 45329 2009 8 PDF Available
Title
Follow-on protein products: scientific issues, developments and challenges
Abstract

Scientific and regulatory issues around approval of follow-on protein products, referred to as biosimilars in Europe, have been a topic of great interest and debate recently. The central issue is our limited understanding of how the different quality attributes of a product have an impact on its safety and efficacy. Crucial gaps in our knowledge include a lack of standardization in the way in which data are collected, analyzed and reported, and limitations in the ability of non-clinical tools for predicting clinical safety and efficacy. Complexity of protein products with respect to the numerous quality attributes and complexity of the biotechnology processes and the raw materials add to the challenges. In this paper, recommendations are presented to help at least partially alleviate these challenges.

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Publisher
Database: Elsevier - ScienceDirect
Journal: - Volume 27, Issue 12, December 2009, Pages 698–705
Authors
,
Subjects
Physical Sciences and Engineering Chemical Engineering Bioengineering
Get Full-Text Now
Don't Miss Today's Special Offer
Price was $35.95
You save - $31
Price after discount Only $4.95
100% Money Back Guarantee
Full-text PDF Download
Online Support
Any Questions? feel free to contact us