Chapter 13. Effective Approaches to Formulation Development of Biopharmaceuticals
- Feroz Jameel3,
- Susan Hershenson4
Published Online: 5 AUG 2010
DOI: 10.1002/9780470595886.ch13
Copyright © 2010 John Wiley & Sons, Inc.
Book Title
Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals
Additional Information
How to Cite
Nayar, R. and Mosharraf, M. (2010) Effective Approaches to Formulation Development of Biopharmaceuticals, in Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals (eds F. Jameel and S. Hershenson), John Wiley & Sons, Inc., Hoboken, NJ, USA. doi: 10.1002/9780470595886.ch13
Editor Information
- 3
Drug Product and Device Development, Amgen Inc., Thousand Oaks, California, USA
- 4
Pharmaceutical and Device Development, Genentech Inc., South San Francisco, California, USA
Publication History
- Published Online: 5 AUG 2010
- Published Print: 26 JUL 2010
ISBN Information
Print ISBN: 9780470118122
Online ISBN: 9780470595886
- Summary
- Chapter
- References
Keywords:
- formulation development - for liquid dosage forms;
- effective approaches - in biopharmaceutical formulation development;
- experiments by design (EbD) approach - in formulation development
Summary
This chapter contains sections titled:
Introduction
Industry Perspective
The Major Challenges
Effective Versus Efficient Formulation Development
Effective Algorithm for Formulation Development
The Experiments by Design (EbD) Approach in Formulation Development
A Case Study for Effective Formulation Development of a Protein
Overall Experiment by Design Strategy
References