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7:30 am Conference Registration and Morning Coffee
8:30 Chairperson’s Opening Remarks
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 Coffee Break Featuring Emerging Companies/Products
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.
12:15 pm Close of Morning Session
12:30 Luncheon Presentations (Sponsorship Opportunities Available) or Lunch on Your Own
2:00 Chairperson’s Remarks
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.
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.
3:35 Sponsored Presentation (Opportunity Available)
3:50 Refreshment Break Featuring Emerging Companies/Products
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 Sponsored PresentationSponsored by
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Presentation to be Announced.
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