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Fifth Annual
Optimizing Biologics Formulation Development
Candidate Screening, Profiling, Developability Assessment, and Optimization
January 21-22, 2013 


Day 1 | Day 2Download Pipeline 1 Brochure 

This annual conference will cover the latest trends and challenges in biologics formulation with a focus on both the optimization of the formulation process and the biologic molecule itself for greater ‘formulatability’ and ‘developability’. It will feature in-depth case studies and interactive discussions on early formulation screening, thorough biophysical and analytical characterization, improving the feedback loop in the early formulation-development interface, use of experimental design and high-throughput principles, overcoming aggregation and other heterogeneity challenges, and improving overall product profile. 


4:00-5:00 pm Registration for Short Courses

5:00 – 8:00 Recommended Dinner Short Courses (SC1-SC4)*

*Separate Registration Required

4:00-8:00 pm Conference Registration


7:30 am Conference Registration and Morning Coffee


Rational Formulation Design 

8:55 Chairperson’s Opening Remarks

Sreedhara Alavattam, Ph.D., Senior Group Leader, Late Stage Pharmaceutical Development, Genentech, Inc.


9:10 DOE or DIE: Choosing between Multivariate and Univariate Experimental Design for Formulation Development of Proteins Including Monoclonal Antibodies

Yvonne LentzYvonne Lentz, Ph.D., Scientist, Late Stage Pharmaceutical Development, Genentech, Inc.

QbD for drug development focuses on multivariate analysis for various parameters in both drug substance and drug product development. The current talk will be based on our recent experience and health authority discussions. Importance of Design of Experiments (DOE, multivariate) or Do Independent Experiments (DIE, univariate) will be discussed. Critical analysis of multivariate and univariate experimental design for formulation parameters will be presented using two monoclonal antibodies as examples.

9:50 Stability Testing and Optimization of Two Lead Human Monoclonal Antibodies

Mohan Srinivasan, Ph.D., Director, Protein Chemistry, Bristol-Myers Squibb

Evaluation of antibodies with stability and manufacturing liabilities is an essential step in biotherapeutic development. Here, we present stability data on two antibodies that have such liabilities in the CDRs. The critical evaluation for potential modifications under stressed and real-time conditions using a variety of biophysical techniques followed by optimization of the sequence liabilities will be presented, since the process, data and scope of optimization might serve as the general template for biotherapeutic development.

10:20 Coffee Break

10:45 Application of QbD in Formulation Development Using a High-Throughput Method, Experimental Design and Statistical Data Evaluation

Stefan Leitgeb, Ph.D., Department Head, Products and Formulations, Research Center Pharmaceutical Engineering GmbH

Differential scanning fluorimetry (DSF) is a new high-throughput technique to be used in formulation development evaluating thermal unfolding in 96- and 384-well plates in conventional RT-PCR instruments for a broad concentration range. Within the QbD concept the application of Design of Experiments using DSF as a method for stability screening is demonstrated. The method has been optimized to show for the first time its applicability in the presence of surfactants. The power of statistical methods is demonstrated to get maximal output of the data available.

11:15 Statistical Process Control for Assay Development

Martin Kane, Ph.D., former Director, Process Statistics, Biostatistics, Human Genome Sciences, Inc.

This talk will focus on the use of Statistical Process Control (SPC) for assay development. It will cover the basics of SPC and how it can be used to alarm the laboratory to assays that are not running in control. These signals are more sensitive and can be seen much earlier than waiting for a failure to occur. SPC is a highly regarded and valuable tool that should be incorporated into every laboratory.

11:45 Overcoming the Formulation/Analytics Challenges for the Development of a Very Low Concentration Protein Product

Bingquan (Stuart) Wang, Ph.D., Manager, Commercial Process Development, Genzyme

I will share lessons learned from the systematic approach we took to tackle the formulation/analytics issues for this case study. The project required an intensive study in formulation/analytical development due to the unexpected protein-free subunit dissociation, aggregation and oxidation issues as well as a complicated lyophilization process. A systematic and rational approach was used to achieve a stable product.

12:15 pm Close of Session

12:30 Luncheon Presentation (Sponsorship Opportunity Available) or Lunch on Your Own


Formulation Development and Screening 

2:00 Chairperson’s Remarks

Stefan Leitgeb, Ph.D., Department Head, Products and Formulations, Research Center Pharmaceutical Engineering GmbH

2:05 Platform Approach for Early Phase Biologics Drug Product Development

Benoit Bossuge, Ph.D., Functional Expert, Pharmaceutical and Analytical Development, Novartis Pharma AG

Resources and high attrition rate associated with the development of new antibodies are a major concern for any biologics development unit of a Pharmaceutical company. Historically, the pharmaceutical development of antibodies was a tailor-fitted-molecule-dependent approach for each new molecule. With an increased amount of antibodies generated by research, a new strategy based on the extensive experience gained with previously developed molecules was developed, significantly reducing the development efforts needed to initiate phase I clinical trials.

2:35 Reversible Self-Association Characterization during Formulation and Characterization of Monoclonal Antibodies

Reza Esfandiary, Ph.D., Scientist, Formulation Sciences, MedImmune

3:05 To Trp or Not to Trp: Screening for Trp Oxidation during Monoclonal Antibody Formulation Development

Sreedhara Alavattam, Ph.D., Senior Group Leader, Late Stage Pharmaceutical Development, Genentech, Inc.

Tryptophans (Trp) play an important role in antigen binding and overall stability of the protein. During mAb formulation development it is vital to understand some of the critical roles that Trp play and how to formulate for successful clinical development of sensitive molecules. New methods to screen for oxidation susceptibility of Trp will be presented.

Unigene3:35 Oral Delivery of Therapeutic Peptides Using Peptelligence

Jane Pepper, Ph.D., Senior Director, Business Development, Unigene Laboratories, Inc.

Oral peptide delivery offers the potential for greater patient acceptance compared to injectable routes. However, the oral delivery of peptides has been historically challenging due to protease degradation, low absorption in the GI tract, and high variability (e.g. food effects). PeptelligenceTM, an oral peptide delivery technology platform that has been validated in late phase clinical trials, systematically addresses these physiological barriers, resulting in enhanced bioavailability and low variability.

3:50 Refreshment Break


Enabling Technologies in Analytical and Formulation Development 

4:15 Systematic Evaluation of Predicting Long Term Protein Stability via Tm Measurements

Gerhard Winter, Ph.D., University Professor, Pharmacy, Ludwig Maximilian University of Munich

Our studies compare long term stability data of a cytokine in solution up to 2 years with Tm values determined with microcalorimetry. Chemical and physical stability are evaluated separately and different approaches to correlate the non-analogous data are taken and assessed. Most interesting result is that Tm predicts long term physical stability better that short term stress studies e.g. at 40°C.

4:45 Characterization of Aggregation in Vaccines and Its Impact on Vaccine Potency

Indresh Srivastava, Ph.D., Senior Director, Project Management, Protein Sciences Corporation

Most of the viral vaccines are based on the surface glycoproteins. These target vaccines have a tendency to aggregate during the production and purification processes. Therefore, there are two most important challenges that we need to address: a) Batch to batch consistency of vaccine in terms of conformation and aggregation; and b) the impact of aggregation on potency of vaccines. To address these points it is important to apply appropriate technique(s) for characterizing aggregates such as light scattering, differential scanning calorimetry, size exclusion, and nanosight imaging; and study the impact of aggregation on vaccine potency. In the presentation, I will review the techniques used for characterization of aggregates in context of HIV and Flu vaccines.

Wyatt5:15 Screening and Characterizing Biomolecular Interactions by Static and Dynamic Light Scattering

Daniel Some, Ph.D., Principal Scientist, Wyatt Technology Corporation

Static and dynamic light scattering are versatile techniques for the quantitative characterization of biomolecular interactions such as reversible self-association, protein-excipient interactions and aggregation. This talk will span topics from high-throughput screening of formulations to in-depth analysis of the affinity and stoichiometry of reversible oligomerization processes, all by means of solution-based light scattering.

5:45 – 7:00 Welcome Reception in the Exhibit Hall with Poster Viewing

7:00 Close of Day

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