Biotechnology-Derived Drug Product Development

Stephen M. Carl,1 David J. Lindley,1 Gregory T. Knipp,1 Kenneth R. Morris,1 Erin Oliver,2 Gerald W. Becker,3 and Robert D. Arnold4 

2Rutgers, The State University of New Jersey, Piscataway, New Jersey 

Pharmaceutical Manufacturing Handbook Production and Processes, edited by Shayne Cox Gad Copyright 2008 John Wiley Sons, Inc. 

Notwithstanding the many technological hurdles to successfully develop a pharmaceutically active biotechnology product, they offer many advantages in terms of 

During the process of lead optimization, characterization work is performed that would include a number of parameters that are critical to formulation and analytical development scientists. The following information is a minimalist look at what information should be available to support product development scientists  

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Robert D. Arnold, The University of Georgia, Athens, Georgia, Biotechnology-Derived, Drug Product Development... 

Gerald W. Becker, SSCI, West Lafayette, Indiana, Biotechnology-Derived Drug Product Development Regulatory Considerations in Approval of Follow-On Protein Drug Products... 

By 1991, more than 375 products had received orphan designation, and more than 40 orphan drugs were available In the US. Nine of the 15 biotechnology-derived drugs on the market have orphan drug status, as do 19 biotechnology-derived drugs under development. Some of these prod-... 

Biotechnology-Derived Drug Products Formulation Development, p. 281. 

Biotechnology and Biological Preparations, p. 258. Biotechnology-Derived Drug Products Formulation Development, p. 281. 

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