Pharmaceutical Manufacturing Handbook: Production and

1.1
BIOTECHNOLOGY - DERIVED DRUG
PRODUCT DEVELOPMENT
Stephen M. Carl, 1
David J.
Kenneth R. Morris, 1
Erin
Robert D. Arnold 4
Lindley, 1
Oliver, 2
Gregory T.
Gerald W.
1
Purdue University, West Lafayette, Indiana
2
Rutgers, The State University of New Jersey, Piscataway, New Jersey
3
SSCI, West Lafayette, Indiana
4
The University of Georgia, Athens, Georgia
Contents
1.1.1
1.1.2
1.1.3
1.1.4
1.1.5
Knipp, 1
Becker, 3
Introduction
Formulation Assessment
1.1.2.1 Route of Administration and Dosage
1.1.2.2 Pharmacokinetic Implications to Dosage Form Design
1.1.2.3 Controlled - Release Delivery Systems
Analytical Method Development
1.1.3.1 Traditional and Biophysical Analytical Methodologies
1.1.3.2 Stability - Indicating Methodologies
1.1.3.3 Method Validation and Transfer
Formulation Development
1.1.4.1 Processing Materials and Equipment
1.1.4.2 Container Closure Systems
1.1.4.3 Sterility Assurance
1.1.4.4 Excipient Selection
Drug Product Stability
1.1.5.1 Defi ning Drug Product Storage Conditions
1.1.5.2 Mechanisms of Protein and Peptide Degradation
1.1.5.3 Photostability
1.1.5.4 Mechanical Stress
1.1.5.5 Freeze – Thaw Considerations and Cryopreservation
1.1.5.6 Use Studies
1.1.5.7 Container Closure Integrity and Microbiological Assessment
1.1.5.8 Data Interpretation and Assessment
and
Pharmaceutical Manufacturing Handbook: Production and Processes, edited by Shayne Cox Gad
Copyright © 2008 John Wiley & Sons, Inc.
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