Wednesday, September 3, 2014

Analytical & Quality at BioProcess International

Attend BioProcess International to stay abreast of emerging analytical tools for non-mAb and next generation biotherapeutics and increasing quality expectations for your products and processes so you can optimize your analytical strategy and reduce quality risk across the product lifecycle.

By attending, you will learn about:
  • ● Physiochemical Characterization
  • ● Variants and Impurities
  • ● Biosimilar Strategies
  • ● Strategies for Complex Glycoproteins
  • ● HT Methods for Stability/Developability
  • ● Quality Risk Management

Featured Session: Elucidating the Structure/Function Relationships of Complex Glycoproteins
  • • Complex Glycoprotein Analysis: Mass Spectrometry-based Approaches presented by Tao He, Ph.D., Associate Research Fellow, Global Biotherapeutic Technologies, Pfizer
  • • Recombinant Protein-therapeutics: Structure-activity Relationship Studies In-vitro and Beyond presented by Yelena Lyubarskaya, Ph.D., Senior Principal Scientist, Analytical Development, Biogen Idec
  • • Testing Strategy as a Holistic Approach: Risk-based Optimization for In-process, Release and Stability Testing presented by Alla Polozova, Ph.D., Principal Scientist, Analytical Sciences, Process Development, Amgen
  • • In vitro Assay Platforms to Asses the Biological Function of Enzymes presented by Peter Bernhardt, Ph.D., Senior Scientist, Analytical Development, Rare Disease Business Unit, Shire
  • • Structure-Function Relationships in Therapeutic Sulfatases presented by Bill Prince, Ph.D., Executive Director, Analytical Chemistry and Formulation, BioMarin Pharmaceutical
  • • Panel Discussion: Strategies and Challenges of Establishing an Analytical Control Strategyfor Complex Biomolecules moderated by Johnson Varghese, Ph.D., Senior Director/Head, Analytical Development, Shire
    • o Establishing criticality of product attributes
    • o Process control for critical quality attributes
    • o Defining the overall analytical testing strategy using the QbD paradigm
    • o State and suitability of the in-vitro bioassays for measuring product quality

Featured Session: Characterization and Control of Variants and Impurities
  • • Emerging Concepts in Process Characterization for Host Cell Proteins: Potential Impact on Biosimilars and Biotech Products presented by Nadine Ritter, Ph.D., President and Analytical Advisor, Global Biotech Experts
  • • Sequence Variant Analysis and Control of a Recombinant Monoclonal Antibody Therapeutic presented by Connie Lu, Ph.D., Senior Scientist, Global Method Management and Technology, Genentech, A Member of the Roche Group
  • • An Unexpected Chemical Modification of a Recombinant Monoclonal Antibody presented by Chris Chumsae, Ph.D., Senior Scientist II, Protein Analytics, AbbVie

Featured Two Day Training Course: Quality Risk Management Across The Biopharmaceutical Lifescycle
This course covers how Quality Risk Management pertains to all stages of the biopharmaceutical lifecycle, from drug development through to patient use and pharmacocompliance. Using case studies, practical examples, and interactive discussion, the instructor will help you learn about or expand your current knowledge of Quality Risk Management. This course will provide you with essential knowledge to make better decisions and include discussions of quality risk management considerations related to: analytical tools, risk-assessment of 'different' applications (e.g., single-use, facility, closed systems), phase-appropriate Quality issues, Quality-by-Design, regulatory ICH guidelines, Continuous Process Verification, knowledge management and much more.

Ben Locwin, Ph.D., Head of Training & Development, Risk and Decision Sciences, Lonza Biopharmaceuticals

Find out more about the Analytical & Quality features at BioProcess International Conference & Exhibition by downloading the brochure.  If you'd like to join us in Boston October 20-23, as a reader of this blog, when you register to join us and mention code BPI14BLOG, you're eligible to save 20% off the standard rate.

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