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Cambridge Healthtech Institute’s second annual “Optimizing Biologics Formulation Development: Managing the Early Formulation-Manufacturing Interface to Overcome Stability, Processing and Manufacturing Challenges and Achieve Fit for Purpose Drug Product” covers the latest trends and challenges in biologics formulation and development with a focus on: improving time to market via early formulations and characterization, overcoming aggregation challenges, utilizing enabling analytical methodologies, using experimental design and high-throughput principles, and improving convenience and compliance through delivery technologies. The conference features novel case studies, in-depth scientific presentations, and poster sessions. Time has been designated for interactive discussions with industry thought leaders during the BuzZ Sessions on Tuesday. It is part 1 of 3 within the “Pipeline 1: Formulating Biologics: Meeting the Challenges” track and is perfect for those new to the field, as well as those who require in-depth analysis of the latest trends, technologies, and techniques.
Monday, January 11
7:30 am - 8:45 am Registration and Morning Coffee
8:45 Chairperson’s Opening Remarks
James Matsuura, Ph.D., Director of Formulation, Althea Technologies, Inc.
9:00 KEYNOTE PRESENTATION
Development Interfaces: Feedback Loops to Improve Formulation, Optimize Process, and Reduce Timelines
Palani Palaniappan, Ph.D., Senior Director, Analytical & Formulation Sciences, Millennium Pharmaceuticals, Inc. a Takeda Oncology Company
9:50 Rotavax™, an Oral Rotavirus Vaccine Product Development Case Study: Science, Marketing, and Business Development Considerations
Satoshi Ohtake, Ph.D., Scientist, Research and Development, Aridis Pharmaceuticals
Room-temperature stable rotavirus vaccine, demonstrating a shelf life of greater than two years, was produced by spray drying. Marketing survey indicated that the current vaccine, in an oral thin film presentation, will be favored both in terms of cost and convenience to current market products. Successful blending of scientific innovation and understanding with business development will be a key factor in determining the market success of the current product. Focus will be given to scientific discovery and challenges encountered in developing the spray dried rotavirus vaccine, as well as to marketing/business considerations, with special emphasis on the importance of the interaction between science and business development.
10:20 Networking Coffee Break
10:45 Strategies for Early Pre-Formulation Research of Therapeutic Proteins
Nick Guziewicz, Ph.D., Principal Research Associate, BioFormulations Development, Genzyme Corporation
11:15 The Relevance of Predictive Tools and Stress Models in Protein Drug Development
Roland Schmidt, Ph.D., Principal Pharmaceutical Scientist, Manufacturing Science, Abbott Laboratories
Stress models and predictive tools, e.g. melting point and second virial coefficient, are commonly used in protein formulation development. An overview of available techniques is presented. Case studies highlight the suitability of various techniques in formulation and process development. The real-world correlation of prediction and real-life process and stability data is critically discussed. Topics include, data driven review of trends in biologics development including QbD concepts, stress types in biologics processing and storage, and tools used to assess and predict protein and formulation stability.
11:45 Utilizing Design of Experiments for Subcutaneous Formulation Development
Phuong Nguyen, Ph.D., Scientist, Parenteral Formulation Sciences, Millennium Pharmaceuticals, Inc.
Design of experiments (DOE) is a powerful tool to obtain insight into experimental systems and to aid in the development of protein formulations. DOE was used to develop a high concentration protein formulation by exploring various inputs such as excipient types, concentration levels, and pH. Through statistical analysis of data obtained from simple experimental designs relating the formulation composition to outputs including stability data, viscosity, and osmolality, much information was gained to allow for further decision-making and to arrive at a suitable formulation.
12:15 pm Close of Morning Session
12:30 Luncheon Presentation (Sponsorship Opportunity Available) or Lunch on Your Own
2:00 Chairperson’s Remarks
Satoshi Ohtake, Ph.D., Scientist, Research and Development, Aridis Pharmaceuticals
2:05 Proximity Energies: A Framework for Understanding High Concentration Fluids
Thomas M. Laue, Ph.D., Professor, Biochemistry and Molecular Biology; Director, Biomolecular Interaction Technologies Center (BITC), University of New Hampshire
Fluorescence detected sedimentation (FDS) provides a means to determine the thermodynamic nonideality of trace quantities of a single kind of labeled macromolecule in the presence of high concentrations of other kinds of macromolecules. Data will be presented showing that the chemical activity of a labeled molecule in a high concentration fluid depends strongly on its electrostatic charge and the charge of the high concentration background molecules. Some of the consequences of these observations to the functioning of biochemical systems will be discussed.
2:35 High Frequency Rheology: A Novel Tool to Understand the Behavior of High Concentration Protein Solutions
Devendra (Davy) S. Kalonia, Ph.D., Professor of Pharmaceutics, University of Connecticut
High concentration solutions are required for subcutaneous injections of many monoclonal antibody formulations. High frequency measurements provide a unique insight into protein-protein interactions and protein flow behavior. The novel technique and its application to optimize formulations will be discussed.
3:05 Dimers and Aggregates and Particles, oh my! New Tools and Techniques for Studying Protein Aggregation
Alan C. Herman, VP of Product Development and Chief Scientific Officer, Althea Technologies Inc.
3:35 Sponsored Presentation (Sponsorship Opportunity Available)
3:50 Networking Refreshment Break
4:15 High-Throughput Stability/Formulation Screening: Correlation between Thermostability and Shelf Life at Accelerated Conditions
Matthías Thórólfsson, Ph.D., Research Scientist, Protein Structure and Biophysics, Novo Nordisk A/S
High-throughput screening with different pH and additives is useful in the selection of protein drug candidates, favorable formulations, as well as finding stable conditions for process support. Different approaches of high-throughput formulation screening in a 96 well-plate format will be addressed for different therapeutic proteins. The thermostability was measured using differential scanning fluorimetry (or thermofluor). Stability over time at constant temperatures was measured with three methods, all of which will be discussed.
4:45 Measuring and Increasing Protein Stability
C. Nick Pace, Ph.D., Professor, Medical Biochemistry and Genetics and of Biochemistry and Biophysics, Texas A&M
Increasing conformational stability of proteins has been an important goal for both basic research and pharmaceutical applications. I will discuss the methods that can be used to measure the conformational stability of proteins. In vitro selection has been used to increase protein stability, but most often site-directed mutagenesis is used to optimize the various forces that contribute to protein stability. I will discuss the most successful approaches based on site directed mutagenesis that can be used to stabilize proteins. In addition, I will discuss non-mutagenic approaches that can be used to stabilize proteins.
5:15 Biophysical Characterization of High Concentration Protein Formulations
Sonoko Kanai, Ph.D., Scientist, Pharmaceutical and Analytical R&D,
F. Hoffmann-La Roche AG
Highly viscous protein formulation poses challenges in manufacturing, reconstitution, and drug delivery. This presentation focuses on the application of biophysical tools to characterize interactions present in high concentration protein formulations. Rheometry and adaptation of analytical tools for high concentration formulation development will be discussed.
5:45 Welcoming Reception in the Exhibit Hall
7:00 Close of Day
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