Main description:

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.

Contents:

1. Principles of Recombinant DNA Technologya. Introductionb. Production methodsc. Purification technologyd. Characterizatione. Analysis and regulationf. Summary points2. Therapeutic Proteinsa. Introduction: Protein/peptide structure and what that means for deliveryb. Delivery challengesc. Potential methods of deliveryd. Summary points3. Therapeutic Antibodiesa. Drug development and antibody engineeringb. Pharmacokinetics of monoclonal antibodiesc. Delivery methodsd. Clinical applicationse. Antibody-specific adverse effectsf. Therapeutic areasg. Summary points4. Analysis and Regulation of Biologics, Including Biosimilarsa. Introductionb. FD&C Act Section 505(b)(2) and the products that currently may be approved via this pathwayc. PHS Act / Biologics Price Competition and Innovation (BCPI) Act of 2009d. Summary Points