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.

Autorentext

Karen Nagel is an Associate Professor of Pharmaceutics at Midwestern University Chicago College of Pharmacy where she has worked since 1999.  She received her Ph.D in Industrial and Physical Pharmacy from Purdue University.  Her current teaching responsibilities include required and elective courses in compounding, dosage form design, biotechnology, and the history of pharmacy.  In order to increase their knowledge of and interest in careers in academia, she precepts several academic APPE rotation students per year.

Dr. Nagel's primary areas of research are herbal product analysis and pharmaceutical compounding.  She also has interests in biotechnology, dosage form design and educational research, and has contributed to several textbooks, review guides and encyclopedias.  Dr. Nagel has been a member of AAPS since 1994 and has served on the planning committee of the local chapter, the Chicagoland Pharmaceutics Discussion Group, since 2002 (Treasurer, 2002-04; Chair, 2005-06).  Dr. Nagel is a past chair (2010-11) of the APhA APRS Basic Sciences section, and has served on the APRS Awards, Education, and Policy committees.  She has also been a member of AACP since 1999, serving as secretary of the Teachers of Pharmaceutics section (TOPS) from 2005-7 and as chair of the Laboratory SIG from 2004-5. She has served as an abstract and grant reviewer for AACP and APhA, and has moderated sessions at annual meetings for both groups.  She also has served on the NABP Foreign Pharmacy Equivalency Exam Review Committee since 2003. Dr. Nagel serves on numerous college and university committees and is faculty advisor to the Midwestern University AAPS Student Chapter.

Inhalt

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