A Best-Practices Exchange with Solutions to Common Problems and Techniques for Next-Generation Products Formulation Strategies for Protein Therapeutics

BPI Contributor

October 1, 2011

3 Min Read



Now in its 11th year, IBC’s Formulation Strategies for Protein Therapeutics is a must-attend annual conference for formulation, delivery, and analytical development scientists from biotherapeutic development organizations around the world. The 28 case studies to be presented at this year’s conference were chosen to offer solutions to the most pressing day-to-day challenges in formulation development for therapeutic proteins. Additional presentations address cutting-edge protein science from leading academics and include briefings on strategic issues of importance to this important field:

  • Solutions to formulation challenges related to subvisible particles, protein stability, design-space development, and manufacturing

  • Novel approaches to product formulation for high-and low-concentration proteins, lyophilized products, packaging, and delivery systems.

Formulation Strategies is colocated with the BioProcess International Conference and Exhibition. This provides the opportunity to visit with more than 150 suppliers of bioprocess technology and services and network with over 1,500 industry leaders.

These topics are new this year:

  • Analytical studies to support formulation development

  • Case studies in resolving formulation problems

  • Formulation for lyophilized products

  • Formulation impacts on biosimilar development

  • Process and manufacturing issues in formulation development.

Conference Sessions

  • Monitoring and Improving Formulation Stability

  • Characterization and Control of Subvisible Particles

  • Formulation Development for High-Concentration Protein Therapeutics

  • Formulation Impacts for Biosimilar Development

  • Formulation for Lyophilized Products

  • Resolving Formulation Problems

  • Design Space and Quality By Design

  • Impact of Packaging and Delivery Devices on Formulation Development

  • Analytical Studies to Support Formulation Development

  • 28 New Case Studies


“Understanding How Solution Conditions Affect Stability by Investigating Site-Specific Changes within Proteins,” by Jennifer S. Laurence (associate professor in the department of pharmaceutical chemistry at the University of Kansas): High-throughput screening aids formulation, but understanding how specific conditions affect a protein’s stability is limited. The research team developed an approach to identify mechanisms by which a protein’s stability is altered by its environment. A straightforward nuclear magnetic resonance (NMR) experiment was used to identify sites where structure is perturbed. To assess stability, the team correlated the NMR data to thermal assay results.

“Evaluation of Formulation Challenges in Biosimilar Development,” by Valentyn Antochshuk (associate principal scientist at Merck Research Laboratories): Biosimilar therapeutic proteins impose additional formulation requirements that are uniquely connected to related innovator products. As companies and regulatory authorities narrow down the concept and approaches, formulation continues to be a key link for stability, safety, and biosimilarity. This presentation evaluates potential challenges faced by formulators during development of biosimilar therapeutic proteins.

Attendees Say

“This conference provided a comprehensive road map to state-of-the-art formulation opportunities and challenges. It provided a snapshot of the latest industry challenges and methods to address these challenges.” —David Hile (senior scientist in formulation development at Stryker Biotech)

“A unique opportunity to get an overview of the latest developments in protein formulation with technical experts from the biotech industry” —Sylvan Huille (formulation development department head at LFB France)

“One of the best biologics formulation conferences” —Tapan Das (senior principal scientist at Pfizer Inc.)


Send a group and save: Discounts are available to groups of three or more. Find complete registration details online, or call 1-800-309-4078. When registering, mention priority code FORFESEPT.

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