The purpose of this book is to give a concise introduction to development and analysis of pharmaceutical biologics for those in the pharmaceutical industry who are switching focus from small molecules to biologics processing, analysis, and delivery. In order to maintain a limited focus, Introduction to Biologic and Biosimilar Product Development and Analysis, will deal only with peptides, proteins and monoclonal antibodies.
1. Principles of Recombinant DNA Technology
a. Introduction
b. Production methods
c. Purification technology
d. Characterization
e. Analysis and regulation
f. Summary points
2. Therapeutic Proteins
a. Introduction: Protein/peptide structure and what that means for delivery
b. Delivery challenges
c. Potential methods of delivery
d. Summary points
3. Therapeutic Antibodies
a. Drug development and antibody engineering
b. Pharmacokinetics of monoclonal antibodies
c. Delivery methods
d. Clinical applications
e. Antibody-specific adverse effects
f. Therapeutic areas
g. Summary points
4. Analysis and Regulation of Biologics, Including Biosimilars
a. Introduction
b. FD&C Act Section 505(b)(2) and the products that currently may be approved via this pathway
c. PHS Act / Biologics Price Competition and Innovation (BCPI) Act of 2009
d. Summary Points
Karen Nagel is an Associate Professor of Pharmaceutics at Midwestern University Chicago College of Plı
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