Wednesday, August 6, 2014

Formulation & Delivery Strategies You Need for Next-Generation Biologics and Protein Therapeutics

This year, the formulation and delivery track at BioProcess International will focus on how to apply innovative technologies and phase-appropriate strategies for formulation development and delivery of mAbs, next-generation biologics, non-mAb protein therapeutics, vaccines and other modalities.

The formulation & delivery track at BPI will teach you how to apply innovative technologies and phase-appropriate strategies for formulation development and delivery. Find new ideas for your mAbs, but even more importantly, learn about formulation development for next-generation biologics, non-mAb protein therapeutics, vaccines and other complex molecules. Discover pre-formulation strategies and techniques for assessing liabilities of molecules to ensure you are progressing candidates with a good chances of success. Hear the latest in high-throughput methods for formulation development. Learn about the connection between formulations and protein/peptide stability and physiochemical characteristics of your molecules.

This track has been designed to showcase new data and multiple case studies from a variety of different molecules to give you new ideas for your own projects. There are also several shared sessions with the analytical track at BPI to help you cross-fertilize ideas regarding analytical strategies for formulation development with attendees of that track.

Agenda at a Glance

Physiochemical Characterization Strategies
  • • Case Study: Assessment of Higher Order Structure Techniques (CD, FTIR and NMR) for Characterization and Comparability of Monoclonal Antibodies
    • >Jasper Lin, Ph.D., Associate Scientist, Late Stage Pharmaceutical Development, Genentech, Inc.
  • • Case Study * New Data: Investigation of Glycan-Structure Function Relationship of an IgG1 using In Vitro Glycoengineering
    • >Marco Thomann, Ph.D., Manager Development Analytics, Roche Diagnostics GmbH, Germany
  • • Particulates Monitoring and Control Strategy for Protein Therapeutics
    • >Arvind Srivastava, Ph.D., Director, Formulation Development, ImClone Systems, a Wholly-Owned Subsidiary of Eli Lilly & Co.

Stability of Protein and Peptide Therapeutics
  • • New Data: Photodegradation of Therapeutic Proteins under Drug Product Manufacturing Relevant Light Conditions
    • >Li Yi, Ph.D., Technical Development Scientist, Genentech, A Member of the Roche Group
  • • Case Study: Formulation Robustness Studies for a High Concentration Antibody Product
    • >Xiaofeng Lu, Ph.D., Principal Research Scientist, AbbVie Therapeutics Inc.
  • • Case Study: Insight into a Complex Degradation Profile: Sometimes the Obvious Answer Isn't the Right Answer
    • >Rachel Varney, Scientist II, Formulation Sciences, MedImmune, United Kingdom

Biosimilar Development and Characterization
  • • The Far Side of Analytical Development of Biosimilars
    • >Roxana M. Butoi, Ph.D., Manager, Analytical Development, GlaxoSmithKline
  • • Recent Developments with Biosimilars in the US
    • >Emily Shacter, Ph.D., Consultant, ThinkFDA, LLC
  • • Analytical Challenges during the Development of a Biosimilar
    • >Hugh D. Conlon, Principal Scientist, Analytical Research and Development, Pfizer

High-throughput Methods and Analytics to Asses Stability & Developability
  • • High-throughput Screening and Early Analytics to Asses Drug-like Properties and Manufacturability
    • >Patricia Lowden, Scientist II, Eleven Biotherapetuics
  • • New Data: High-throughput Protein Covalent Aggregation Measurement by Automated Simple Western Blot System Using Cell Culture Material
    • >Janet Lau, Ph.D., Scientist I, Cell Culture Development, Biogen Idec
  • • Case Study * New Data: High-throughput Characterization and Stability of Biologics
    • >Leena Philominathan, Ph.D., Scientist, Analytical Sciences, Alexion Pharmaceuticals

Pre-formulations, Developability and Liability Assessments
  • • New Data: A Holisitc Approach to Early Pre-formulation and Developability Studies Can Inform and Speed up Later HCLF and Process Development Work
    • >Mark Krebs, D. Phil, Senior Scientist, Protein Pharmaceutical Development, Biogen Idec
  • • New Data: Use of Intrinsic Viscosity to Quantitate Protein-protein Interactions for Predicting Drug-like Properties in Solution
    • >R. Joe Carrillo, Ph.D., Senior Scientist, Pre-formulation, Abbvie Bioresearch Center
  • • Case Study * New Data: Measurement of Charge: An Important Molecular Property for Predicting High Concentration Behavior
    • >Sumit Goswami, Ph.D., Senior Scientist, Biotherapeutics, Pharmaceutical R&D, Pfizer

Formulation Development Case Studies
  • • Case Study: Phase-Appropriate Formulation Development for Late Stage Monoclonal Antibodies - Successes and Lessons Learned
    • >Angela W. Blake-Haskins, Ph.D., Manager, Biopharma, Drug Product Sciences Department, GlaxoSmithKline
  • • Case Study * New Data: Formulation Development Case Studies
    • >Carsten Olbrich, Ph.D., Senior Scientist, Formulation Development, Bayer Pharma AG, Germany
  • • Case Study * New Data: Rapid Reformulation of an Enzyme Product to Improve Particle Formation and Stability
    • >Victoria A. Dowling, Ph.D., Associate Director, Biopharmaceutical Development, KBI Biopharma, Inc.

Vaccine Formulation Development
  • • Innovative Characterization Methods to Identify an Optimal Vaccines Drug Product Formulation
    • >Patrick Ahl, Ph.D., Assistant Principal Scientist, Vaccine Drug Product Development, Merck Research Labs
  • • New Data: Biophysical Characterization of Flublok, a Recombinant Hemagglutinin (rHA) Influenza Vaccine, by Differential Scanning Fluorimetry
    • >Erin Matthews, Ph.D., Group Leader, Analytical Development, Product Realization, Protein Sciences Corporation
  • • New Data: Reinventing the Gene Vaccine: Stabilization and Delivery of Self-amplifying mRNA
    • >Luis Brito, Ph.D., Head, Formulation Science, Novartis Vaccines

Formulations Development for Next-Generation and Complex Molecules
  • • New Data: DoE HTP Plate-based Antibody Drug Conjugation Formulation Screen for Optimal Buffers and Excipients: Accelerated Stability Characterization of Physical and Chemical Stability
    • >Stanley Kwok, Ph.D., Senior Scientist, Formulations, Fill/Finish, Seattle Genetics
  • • Case Study: Formulation Perspectives of Therapeutic Peptides
    • >Ana Santos, Ph.D., Formulation Senior Scientist, Biopharmaceutical Development, MedImmune, United Kingdom
  • • Case Study * New Data: Formulation Development of PEGylated Biologics: The Effect of Linker Chemistry on the Stability of the Polymer Conjugate
    • >Roger H. Pak, Ph.d., Senior Principal Scientist, BioTherapeutics Pharmaceutical R&D, Pfizer, Inc.

Innovative Formulation and Delivery Approaches
  • • Case Study * New Data: Formulation Strategies for Developing Innovative Combination Products for Rare Diseases
    • >Sujit Basu, Ph.D., Head, Drug and Combination Products, Global Technical Operations, Shire
  • • Delivery of Biologics by Microneedles: Manufacturing Capability and Clinical Readiness
    • >Daniel Dohmeier, MTS Formulation Development Group Leader, 3M

Challenges and Considerations around Relaxing Environmental Controls in Biopharmaceutical Facilities

Speakers and Panelists:
  • • Jeffrey Skene, Acting Chief, Monoclonal Antibodies Division, Health Canada
  • • Marc Pelletier, Ph.D., Director of Biotechnology, CRB Consulting Engineers
  • • Joel Gates, Director of Quality Assurance, Shire
  • • Alex Tschumakow, Director, Manufacturing, Shire
  • •Anastasia Lolas, Owner & President, Visionary Pharma Consulting LLC
  • • Paul Smock, Biotechnology Quality and Technical Consultant

Would you like to join us for the Formulation and Delivery track featuring insights from companies like ImClone Systems, Roche, Abbvie Therapeutics, MedImmune and more? As a reader of this blog, when you register to join us at BioProcess International Conference and Exhibition October 20-23 and mention code BPI14BLOG, you can save 20% off the standard rate! Have any questions or want to get involved? Feel free to reach out to Jennifer Pereira.

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