Institute for International Research

IBC's 8th Annual Formulation strategies for Protein Therapeutics conference welcomed 150 participants to the beautiful Disneyland Hotel in Anaheim, California for three full days of presentations and networking to discuss solutions to the evolving challenges of developing novel, stable and effective formulation for protein drug products.

The Formulation meet began with a pre-conference workshop called "Developing Formulations for Pre-Filled Syringe-Based Products - From Early Development to Commercialization." The large attendance for this session reflected the industry's new focus on the use of pre-filled syringes as a delivery platform. Speakers from Amgen, Merck, Human Genome Sciences, Biogen Idec, West and the United States FDA offered a morning or strategies, case studies and regulatory updates in this rapidly-growing field.

A highlight of the meeting was the Tuesday morning session on the interface of formulation development with Quality by Design (QbD) programs now being launched across the industry. This segment began with a Keynote from Dr. Joseph Phillips, Amgen's Executive Director of Formulation and Analytical Development that explored the identification of critical product attributes and their contribution to the development of the design spaces used to guide formulation development. The Keynote was followed with a spirited panel discussion, "The QbD Pioneers: Perspectives from Companies that have Implemented Quality by Design Concepts in Formulation Development," featuring participants from Tunnell Consulting, Merck, Wyeth Biopharma, Pfizer, Seattle Genetics and Biogen Idec.

Other sessions at the meeting included:

• Predictive Methods for Formulation Development
• Formulation Development for Lyophilized Products
• Formulation Development for Novel Proteins
• Advancing Formulation Development for High Concentration Protein Products
• Improving the Stability of Protein Therapeutics
• Measuring and Predicting Protein Aggregation

As in past years, the meeting was co-located with the annual BioProcess International Conference & Exhibition (BPI), and attendees had the opportunity to visit the BPI hall and network with the over 1,500 attendees from the BPI conference.