Introduction to Biologic and Biosimilar Product Development and Analysis

1. Front Matter

   Pages i-xi

   PDF

2. Principles of Recombinant DNA Technology

   • Karen M. Nagel

   Pages 1-29

3. Therapeutic Proteins

   • Karen M. Nagel

   Pages 31-54

4. Therapeutic Antibodies

   • Karen M. Nagel

   Pages 55-86

5. Analysis and Regulation of Biologics, Including Biosimilars

   • Karen M. Nagel

   Pages 87-97

6. Back Matter

   Pages 99-109

   PDF

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.

 

• recombinant DNA technology
• Therapeutic Proteins
• Therapeutic antibodies
• Biologics analysis
• biologics regualtion

• Chicago College of Pharmacy, Midwestern University, Downers Grove, USA

  Karen M. Nagel

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.

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