Biosimilars and interchangeable biologics : tactical elements

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Biosimilars and interchangeable biologics : tactical elements

Bibliographic Details
Main Author:	Niazi, Sarfaraz , 1949- (Author)
Format:	Book
Language:	English
Published:	Boca Raton, Florida : CRC Press c2016
Subjects:	Biosimilar Pharmaceuticals > Standards Drug Approval Drug Discovery > Standards Drug Evaluation > Standards Drug Industry > Standards

Table of Contents:

1. Structural and functional considerations
2. Immunogenicity considerations
3. Product development strategies
4. Stability and formulation considerations
5. Establishing biosimilarity
6. Recombinant expression systems
7. Upstream systems optimization
8. Downstream system optimization
9. Single use manufacturing systems (SUMS)
10. Commercial manufacturing systems
11. Outsourcing considerations