• Reversed-Phase HPLC
• Capillary Electrophoresis 
• Mass Spectrometry and LC-MS

The regulations issued by the FDA on May 14, 1996 substantially changed the way in which biotechnology-derived pharmaceuticals are regulated, placing greater emphasis on the methodologies used to analyze biotechnology-derived polypeptide therapeutics.
The Analysis and Characterization of Protein Therapeutic Drugs immerses those attending in the practical aspects of characterizing and analyzing therapeutic proteins and presents in an adsorbing manner the fundamental principles and practical uses of the three primary analytical technologies and several auxiliary analytical methods.
Topics extraneous to protein analysis are eliminated, allowing the course to focus on the points of each technology essential to protein characterization. The materials can become almost overwhelming because of the shear weight of information presented, and yet all points become clear because of the structure of the class and the ability of the instructor to present each topic clearly. Those attending leave with a clear sense of where each technology is used and how to most effectively implement each technology in characterizing and analyzing therapeutic proteins.
Course attendees can anticipate an educational, yet entertaining, presentation with ample opportunity for discussion and questions.

• Very good understanding of what is needed to adequately analyze and characterize protein therapeutics
• Available techniques to analyze and characterize proteins and their strengths and weaknesses
• Clear understanding of how to get the best benefits of reversed-phase HPLC.
• Understanding of how to control the important conditions in reversed-phase HPLC to maximize resolution
• Knowledge of other chromatographic techniques and their place in protein analysis
• Understanding of capillary electrophoresis and where this fits in the current array of techniques used to analyze proteins
• Up-to-date perspective on mass spectrometry and how this technique can be utilized to assist in analyzing and characterizing protein therapeutics

• Brief history:
  FDA regulation of biotechnology-derived polypeptide therapeutics
• Needs and challenges in the analysis of biotechnology-derived therapeutics:
  peptide mapping, deamidation and oxidation. Glycosylation and its role in protein therapeutics, protein engineering techniques (i.e. pegylation) and monoclonal antibodies
• Reversed-phase HPLC:
  Basic theory of protein/peptide analysis by reversed-phase HPLC, parameters that affect the resolution of proteins and peptides, RP-HPLC in the use of protein analysis, peptide maps, deamidation and oxidation and other protein modifications, analytical parameters that allow optimum resolution of proteins and peptides
• Other chromatographic techniques used in protein therapeutic analysis:
  Ion Exchange, Gel Filtration and other forms of chromatography: how they are used in the analysis of protein therapeutic drugs and protein glycosylation
• Capillary Electrophoresis:
  The use of High-Performance Capillary Electrophoresis (HPCE) in the analysis of polypeptide therapeutics, mechanism and important concepts of HPCE for Capillary Zone Electrophoresis, Isoelectric Focusing CE and SDS Non-gel Sieving CE, operating parameters and practical applications - current use in the analysis of protein therapeutics
• Mass Spectrometry:
  Basic principles and instrumentation in MS analysis of proteins and peptides, electrospray and MALDI as ionization sources and quadrupole, ion trap and time-of-flight mass analyzers, use of LC-MS, examples of how MS can be used to analyze and characterize protein therapeutics

• Biologists and non-analytical scientists involved in the development, production or quality control of protein therapeutic drugs
• Scientists with previous experience in the analysis of small molecules who desire to become familiar with the techniques and methods for the analysis and characterization of proteins
• Scientists new to working with protein or peptide drugs