Third Annual Optimizing Biologics Formulation Development
Hotel Del Coronado
1500 Orange Ave. Coronado 92118
San Diego, California
Overcoming Stability, Processing and Manufacturing Challenges to Achieve Fit-for-Purpose Drug Product 

This annual meeting covers latest trends and challenges in biologics formulation with a focus on improving time to market via early formulations and characterization
and overcoming challenges in stability. It features in-depth case studies and interactive discussions on early formulations and characterization, screening,
overcoming aggregation challenges, utilizing enabling analytical methodologies, managing tech transfer challenges, and use of experimental design and highthroughput

Schedule of Presentations:

Monday, January 10, 2011
07:30:00 Conference Registration and Morning Coffee
08:25:00 Introductory Perspectives: Particulates And Product Quality
08:30:00 Chairperson’s Opening Remarks
08:45:00 Recent Perspectives on Aggregates and Particulates in Biologics Formulations Palani Palaniappan
09:35:00 The Formulation and Immunogenicity of Therapeutic Proteins: Product Quality as a Key Factor Joel Richard
10:05:00 Coffee Break Featuring Emerging Companies/Products
10:40:00 Formulation Screening And Optimization
10:45:00 Screening for Protein Stability Matthías Thórólfsson
11:15:00 Increasing Efficiency of Formulation Development for Adnectins through High- Throughput Screening Bernice Yeung
11:45:00 A High-Throughput Method to Predict the Aggregation Propensity of Proteins Neeraj J Agrawal
12:15:00 Close of Morning Session
12:30:00 Luncheon Presentations | Lunch on Your Own
13:55:00 Formulation Screening And OptimizatioN | (Continued)
14:00:00 Chairperson’s Remarks
14:05:00 The Use of Forced Degradation to Optimize Protein Formulation J. Andrea Ji
14:25:00 Predictive Tools For Formulation Development
14:35:00 Early Formulation Screening of Monoclonal Antibodies: Selecting Molecules with Optimal Physical and Chemical Stability Vikas Sharma
15:05:00 Rational Choice of Excipients for Lyophilized Formulations Evgenyi Shalaev
15:35:00 Sponsored Presentation
15:50:00 Refreshment Break Featuring Emerging Companies/Products
16:30:00 Hydrogen/Deuterium Exchange with Mass Spectrometric Analysis for Assessing Conformation and Excipient Interactions of Lyophilized Proteins Elizabeth Topp
17:00:00 Sponsored Presentation
17:30:00 Causal Factors and Correlations in Freeze-Dried Protein Stability Marcus Cicerone
18:00:00 Welcoming Reception | Exhibit Hall
19:30:00 Close of Day
Tuesday, January 11, 2011
07:30:00 Breakfast Presentation | Morning Coffee
08:15:00 Chairperson’s Opening Remarks
08:20:00 Particle Analysis as a Formulation Development Tool Shannon Southall
08:50:00 Particles and Aggregates in Biotech Drug Products Hanns-Christian Mahler
09:20:00 Formulation Development of Dual-Variable-Domain Immunoglobulins as the Next- Generation of Bispecific Biologics Wolfgang Fraunhofer
09:50:00 Automated Measurement of Protein Conformation in Solution Using the ChirascanTM-auto David Gregson
10:05:00 Coffee Break | Exhibit and Poster Viewing
10:45:00 An Alternative Approach for Delivering High Dose Biologics Subcutaneously Tzung Yang
11:15:00 Early Development of a Novel Formulation for Inhalation Andrea Leone-Bay Leone-Bay
11:45:00 Optimizing Processing Conditions to Avoid Process Stress Induced Aggregation Carl Charlie Hitscherich
12:15:00 Close of Morning Session
12:30:00 Luncheon Presentations
14:00:00 BuzZ Session A | Interactive participation leads to problem-solving solutions and future collaborations around focused topics
14:45:00 Refreshment Break | Exhibit Viewing and Poster Awards
15:30:00 BuzZ Session B | Interactive participation leads to problem-solving solutions and future collaborations around focused topics
16:15:00 End of Conference
16:30:00 Concurrent Dinner Short Courses
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