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IBC's 22nd Annual International Conference IBC's 9th Annual International Conference
Antibody Engineering Antibody Therapeutics
Annual Meeting of The Antibody Society
December 4-8, 2011 • Hilton San Diego Bayfront Hotel • San Diego, CA
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Event Information

產業會議彙總曆
生物科技相關國際會議

生物科技相關國際會議

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Cutting-Edge Basic Science Combined with Updates on Clinical Progress

2011年12月4-8日 · Hilton San Diego Bayfront Hotel · San Diego, CA

專業發展課程

專業發展課程 · 2011年12月4-5日

Introduction to Antibody Engineering

Protein Characterization for Biotechnology Product Development

Description

Today's wealth of knowledge of protein structures will be reviewed along with the genetics of diversity generation of antibodies, to give insights into the best strategies for improving protein function. There is particular emphasis on the choice of a functional assay to monitor effectively the changes in a desired property, and the use of functional enrichment steps where a library approach is employed. Not only is amino acid sequence amenable to engineering, but glycan structures and other modifications may also be engineered. The course will focus on the engineering and enhancement of antibodies and antibody-like scaffolds. Examples will include work on antibody fragment affinity improvement by 100-fold to low pM affinity. A background in biochemistry and molecular biology is useful, as the course is designed to progress rapidly from simple to advanced concepts.

Instructor

David Bramhill, Ph.D., Director, Research Corporation Technologies

Course Agenda

  • Functions amenable to engineering: affinity, specificity, stability, solubility, immunogenicity
  • The measure of success: functional assays
  • Engineering by design
  • Engineering by random mutation
  • Designed libraries
  • Display technologies
  • Improving manufacturing by protein engineering methods
  • Glycosylation engineering - function and homogeneity
  • Other protein modifications
  • Immunogenicity engineering
  • Bispecific antibodies
  • Antibody-drug conjugates (ADCs)

Description

This course covers the fundamentals of protein structural analysis using modern biochemical and biophysical technologies. We will review the post-translational modifications commonly observed on recombinant proteins produced from manufacturing cell lines and discuss the potential impact of the structural heterogeneities on biological activity. In addition, characterization of higher order structures, aggregates and particulates, binding and cell-based potency assays will be discussed. The impact of bioprocess parameters, including cell line selection, on product quality profile will be reviewed. Examples on characterization of different recombinant proteins including monoclonal antibodies using key orthogonal techniques will be highlighted. The objective is to provide participants with key technical information along with perspectives to enable them to apply the technologies to their own projects and evolve their own analytical strategies to support the various stages of product development.

Instructor

Christine P. Chan, Ph.D., Senior Manager, Technology Development, Genzyme Corporation

Course Agenda

  • Introduction to protein structure and post-translational modifications
  • Protein Chemistry Techniques: capillary electrophoresis and HPLC, enzymatic methods and peptide mapping, mass spectrometry, amino acid analysis, top-down and bottom-up protein sequence analysis , sample treatment, preparation & work flow
  • Biophysical Characterization: spectral methods including vibrational spectroscopy, fluorescence and circular dicroism. Light scattering, calorimetry, analytical ultracentrifugation, atomic force microscopy, and field flow fractionation techniques. Aggregation, subvisible and visible particles analysis.
  • Quality control of biotechnology products: guidance documents
  • Characterization of recombinant protein products: glycosylation analysis; monoclonal antibody structure and subclasses, additional recombinant proteins, product heterogeneity analysis
  • Bioprocess impact on product quality: cell line selection, upstream process variables, downstream process impact, formulation/fill/finish and storage
  • Quality by Design and process development, process transfer, comparability considerations
  • Selecting characterization methods to support early vs. late stage product development

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