January 13 - 17, 2014
Renaissance Hotel and Palm Springs Convention Center Palm Springs, California

A Community Dedicated to the
Evolving Field and Future of Biotherapeutics

Pipeline 1 Formulating Biologics


Day 1 | Day 2 | Download Brochure 

Conference Short Courses*View Details 

Sunday, January 9 - 3:00 pm - 6:00 pm

  • Characterization and Analysis of Particulates
  • Protein Crystallization - Delineating Protein Structure
  • DoE and QbD: Tools for Optimizing the Bioprocess

Tuesday, January 11 - 4:30 pm - 7:30 pm

  • Dynamic Light Scattering - Theory, Do's & Don'ts, and  Data Interpretation

Thursday, January 13 - 6:30 pm - 9:00 pm

  • Rational Design of Protein Solutions

 

MONDAY, JANUARY 10


7:30 am Conference Registration and Morning Coffee

 

Introductory Perspectives: Particulates And Product Quality

8:30 Chairperson’s Opening Remarks

Wolfgang Fraunhofer, Ph.D., Associate Research Fellow, Group Leader, Pharmaceutics, Global Pharmaceutical & Analytical Sciences, Abbott

8:45 Recent Perspectives on Aggregates and Particulates in Biologics Formulations

Palani Palaniappan, Ph.D., Senior Director, Analytical & Formulation Sciences, Millennium: The Takeda Oncology Company

Protein aggregation and particulation has been a long standing issue in successful discovery and development of biologics. More recently, this issue has come to the forefront of drug product manufacturing and quality. A high level summary of recent happenings in this area including our own studies will be the focus of this presentation.

9:35 The Formulation and Immunogenicity of Therapeutic Proteins: Product Quality as a Key Factor

Joel Richard, Ph.D., Senior Director, Head of Drug Product Development, Pharmaceutical Development, Ipsen

This talk discusses immunogenicity issues in biopharmaceutical drug development, with a focus on product quality. Excipient-induced and aggregate-induced immunogenicity are reviewed based on the concepts of ‘aggregation-competent’ species and ‘provocative’ aggregates. In addition, influence of formulation parameters, such as particulate and contaminants appearing in the drug product during processing and storage, on aggregate-induced immunogenicity are presented, including the role of fill-and-finish equipment and the effect of interaction with container materials.

10:05 Networking Coffee Break

 

Formulation Screening And Optimization

10:45 Screening for Protein Stability

Matthías Thórólfsson, Ph.D., Senior Research Scientist, Protein Structure & Biophysics, Novo Nordisk A/S

Many of the current qualified and orthogonal methods for biophysical characterization can be adapted to semi or full high-throughput format, and among these are steady-state fluorescence, absorbance, dynamic light scattering, SDS electrophoresis, and differential scanning fluorimetry. Stability screening can be done, using different setups, but is mostly focused on finding stable conditions for liquid formulation, as well as gathering information that is important for bioprocessing and modifications such as pegylation or other covalent conjugations. The talk will focus on what screening techniques and approaches are relevant and valuable in lead selection criteria and pre-clinical formulation.

11:15 Increasing Efficiency of Formulation Development for Adnectins through High-Throughput Screening

Bernice Yeung, Ph.D., Director, Protein Analytics, Process Development, Adnexus, a Bristol-Myers Squibb R&D Company

A new strategy for high-throughput formulation screening for Adnectin proteins has been developed and implemented. Limited stability performed under stress conditions allows for differentiation of the formulations, with promising candidates emerging in two weeks. Execution of this strategy using robotics and subsequent stability testing in well plate format further cuts down on time and variability, allowing higher accuracy and speed to be achieved in the formulation development for Adnectins.

11:45 A High-Throughput Method to Predict the Aggregation Propensity of Proteins

Neeraj Agrawal, Ph.D., Post-Doctoral Associate, Chemical Engineering, Massachusetts Institute of Technology

A novel high-throughput screening tool is presented for predicting relative aggregation propensities of therapeutic proteins. The tool calculates the relative aggregation propensity based on detailed molecular simulations of the proteins at the formulation conditions. This novel strategy based on molecular modeling can incorporate developability and manufacturability early in the protein drug development and thus reduce overall time from discovery to market launch. Furthermore, the tool offers a rational approach to systematically design aggregation-resistant proteins via protein engineering.

        Sponsored by
Freeslate 
12:15 A High Throughput, Parallel, Microscale, Fully Automated Approach to Biologics Formulation Development and Stress Test Studies
Paul DiGregorio, Ph.D., Workflow Architect, Freeslate
The development of robust formulations for biologics requires the screening and analysis of a comprehensive matrix of formulation compositions and stress conditions.  This talk will focus on the development and use of a fully-automated workflow for stressing these types of formulations and assessing their stability through a range of integrated analytics.  Intended to fit into a Quality by Design (QbD) program enabling a more comprehensive view of product attributes and process, the system integration through Freeslate’s Laboratory Execution and Analysis (LEA) software informatics platform allows scientists to view, aggregate, and make conclusions on the large analytical datasets collected. 

12:30 Luncheon Presentations (Sponsorship Opportunities Available) or Lunch on Your Own

 

Formulation Screening And Optimization (Continued)

2:00 Chairperson’s Remarks

Joel Richard, Ph.D., Senior Director, Head of Drug Product Development, Pharmaceutical Development, Ipsen

2:05 The Use of Forced Degradation to Optimize Protein Formulation

J. Andrea Ji, Ph.D., Late Stage Pharmaceutical and Processing Development, Genentech

We will discuss how forced degradation can effectively ensure a stable protein formulation, how to design suitable stress conditions for forced degradation studies, and determine the optimal stage in development to conduct these studies.

 

Predictive Tools For Formulation Development

2:35 Early Formulation Screening of Monoclonal Antibodies: Selecting Molecules with Optimal Physical and Chemical Stability

Vikas Sharma, Ph.D., Scientist, Early Stage Pharmaceutical Development, Genentech

3:05 Rational Choice of Excipients for Lyophilized Formulations

Evgenyi Shalaev, Ph.D., Associate Research Fellow, Parenteral Center of Emphasis, Pfizer

Buffer salts, bulking agents, and lyoprotectors represent most common types of excipients for proteins and other biologicals. Understanding impact of excipients on stability and manufacturing is a basis for rationale development of freeze-dried proteins and vaccines, and is a must to support QbD development. The presentation describes impact of excipients on both stability and freeze-drying properties of pharmaceuticals and biotech products. The audience will get a systematic overview of critical properties of buffers, lyoprotectors, and other excipients as applied to formulation and process development of biologicals.

Sponsored by
Avacta logo
3:35 High Throughput Measurement of Multiple Potential Predictors of Long Term Stability
Daniel Lund, Ph.D., Applications Manager, Avacta Analytical Ltd
There is a pressing need to identify as early and as quickly as possible which molecules and formulations will be stable over extended storage periods. The melting point of a protein in a given formulation is widely used as an indicator of conformational stability. There are a range of additional parameters that can be measured and may give insight into the long term stability of a protein. We present data from a high-throughput technology that rapidly and simultaneously acquires a range of additional stability data whilst consuming very small amounts of protein that may be used in the selection of candidates or formulations to take forward.

3:50 Networking Refreshment Break

 

4:30 Hydrogen/Deuterium Exchange with Mass Spectrometric Analysis for Assessing Conformation and Excipient Interactions of Lyophilized Proteins

Elizabeth Topp, Ph.D., Dane O. Kildsig Professor and Department Head, Industrial Pharmacy and Pharmaceutics, Purdue University

Lyophilized forms of peptide and protein drugs are used for bulk drug storage and in marketed products. Our group has developed hydrogen/deuterium exchange with mass spectrometric analysis for lyophilized proteins. The method provides insights into protein conformation and excipient interactions, with peptide-level resolution.

5:00 The Benefit of Crystallization to Protein Formulation: Stable, High Concentration and/or Controlled Release Formulation of Drugs

Sponsored by
Althea small logo

Bhami Shenoy, Ph.D., Crystalomics Consultant, Althea Technologies, Inc.
James Matsuura, Ph.D., Director, Formulation Development, Althea Technologies, Inc.
Although crystals are the preferred state for small molecule formulation, crystallization is seldom used for protein pharmaceuticals, even though it can offer significant advantages: a) greater stability, b) higher concentrations, and c) convenient controlled release forms. As part of a systematic effort to fully integrate crystallization in protein drug formulation, we showed that the cycle of crystallization and dissolution does not change the fundamental properties of a protein, thus preserving its therapeutic effect. Data suggests that crystallization can significantly improve the way biopharmaceuticals are formulated and delivered.

5:30 Causal Factors and Correlations in Freeze-Dried Protein Stability
Marcus Cicerone, Ph.D., Research Chemist, Polymers, NIST
Protein secondary structure and alpha relaxation of the freeze-dried solid have been used as metrics for predicting the effectiveness of a freeze-dried formulation, but these metrics are not quantitative, and not always reliable. I will present evidence that protein secondary structure in the freeze-dried solid is only a correlation, and only holds in a limited regime. I will also show that, in order to be quantitative, alpha relaxation data must be supplemented by beta relaxation data.

6:00-7:30 Welcoming Reception in the Exhibit Hall

7:30 Close of Day

Day 1 | Day 2 | Download Brochure



Links to Companion Meetings

Pipeline 1

Protein-Device Combinations 

Lyophilization, Spray Drying & Emerging Drying Technologies 

Protein Aggregation and Emerging Analytical Tools

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      Premier Sponsors: 

EMD Millipore 

 Novozymes (white) 

PerkinElmer NEW 2009 

 Protein Simple  

  

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Training Seminars 

Mon-Tues, January 13-14 

Biologics Formulation and Delivery  

 


Buzz Sessions
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