with special emphasis on:
- Ensuring Sameness for Clinical Trials
- Analytical Methods
- Crystallization & Protein Crystals
- Formulations
- Stability
Dr. Stephen R. Byrn
Dr. John F. Carpenter
Dr. Michael J. Pikal
Dr. George Zografi
and SSCI Scientists
This two-day course is aimed at professionals in the biotech and pharmaceutical industry who would like to expand their knowledge base for biopharmaceutical solids. It will provide information that enables faster drug development. The course will also present strategies to ensure that the same drug substance and drug product is used for each clinical trial. Presenters will discuss strategic approaches to understanding and predicting the properties and pharmaceutical behavior of biopharmaceutical solids, as well as the important area of regulatory aspects of pharmaceutical and biopharmaceutical solids. Participants will each receive a course notebook.
The course will address the following questions:
- What types of studies are required to determine the identity and sameness of solid forms of biopharmaceuticals?
- What information can be gained from analytical studies of biopharmaceuticals and their formulations?
- What should be done to characterize amorphous solids?
- How can stability and rates of transformation be analyzed and predicted?
- What role does water play in the identity and sameness of biopharmaceuticals?
- What specifications should be set and how can analytical procedures for mixtures of solids be developed and validated?
- What is recommended in a regulatory submission (Q6A) and how should it be approached?
This course on biopharmaceutical solids provides a fast-paced, cutting-edge overview of the ideas, issues, language, and methodologies of biopharmaceutical solid-state research. This course will help professionals in the biotechnology industry understand a strategy for characterization of their drug substance and drug product. It will allow these professionals to develop strategies for control during clinical trials and prepare a strong submission to the FDA. This course will also outline strategies to ensure that the same drug substance and drug product is used for each clinical trial.
Biopharmaceutical Solids: Introduction
Basic Definitions and Course Overview
Crystalline Materials -- Crystallization, structure, properties
Amorphous Materials -- Formation, structure, mobility, dynamics
Methods of Analysis
X-ray Powder Diffraction
Thermal Methods -- DSC, TGA, modulated DSC, fragility determination
Microscopy
IR and Spectroscopy -- Measurement of stability
Water Analysis -- Moisture balance
Solid-State NMR
Particle Size Analysis
Water
Role of Water in Solid Biologicals
Water in Sugars, Polymers, and Amorphous Materials
Manufacturing
Crystallization of Proteins
Formulation of Biologicals
Stability
Basic Mechanisms of Degradation
Physical Instability
Stability of Formulations
Crystallization and Other Strategies to Improve Stability
Conclusion
Regulatory Strategies
The Concept of Sameness
Both days of the course will begin at 8:00 AM and end at 5:00 PM.
The course will be held at the Marriott San Mateo/San Francisco Airport in San Mateo, CA. The hotel is close to San Francisco International Airport and offers shuttle transportation to and from the airport. The cost of your hotel room is not included in the course fee, and you must make your own arrangements for lodging. A block of rooms at the hotel will be held for SSCI short course participants at a discounted rate until February 12, 2007. The discounted rate is available only for the nights of Monday, February 26, Tuesday February 27, and Wednesday, February 28. Early check-in will be available on Tuesday morning. Please make your reservations by calling the hotel at 1-650-653-6000 before February 12, 2007. Be sure to mention that you will be attending an SSCI short course to ensure the discounted rate.
To register, please use our registration form. You may also mail or fax in your registration form. The number of participants is limited, so please register early! A course outline and directions to your hotel will be mailed with confirmation of your registration.
The course fee of $1,195.00 (US dollars) includes taxes, luncheons on all days, beverage breaks, and course notes. You may pay for the course using a credit card, check, or purchase order. Government employees may contact SSCI to ask about discounted fees. Please note that the cost of your hotel room is not included in the course fee. You are responsible for making your own hotel reservations.
For further information, please contact SSCI Inc.
Telephone: 765-463-0112 / 800-375-2179
Fax: 765-463-4722
SSCI, Inc. provides a wide range of research and analytical services focused on pharmaceutical and biopharmaceutical solids. We are experts in the characterization, chemistry, and properties of solid materials. SSCI operates at the forefront of technology in these areas:
- Polymorphism and salt selection studies
- Solid-state analytical research
- Characterization of small molecule and biopharmaceutical solids
- Analysis of drug substance and dosage form
- Verification of sameness for drug substance production and clinical trials
- Production control
- Development of analytical methods and strategies (traditional and on-line)
- Expert services and litigation assistance
All work at SSCI, Inc. is carried out in strict compliance with cGMP. Rush services are available for analytical and contract research work. For detailed information on SSCI's research, analytical, and consulting capabilities, and for upcoming conference presentations and short courses, visit the SSCI web site: www.ssci-inc.com.
Dr. Stephen R. Byrn is Charles B. Jordan Professor at the School of Pharmacy, Purdue University and also Head of the Department of Industrial and Physical Pharmacy. His research focuses on the solid-state chemistry of drugs and has emphasized the application new instrumental techniques to pharmaceutical problems. He is a member of the USP Council of Experts and past chair of the FDA pharmaceutical sciences advisory committee. He is also extensively involved in stability studies of solids. Dr. Byrn has broad experience as a consultant in the pharmaceutical industry and is one of the founders of SSCI.
Dr. John F. Carpenter is Associate Professor of Pharmaceutical Sciences at the University of Colorado School of Pharmacy and a co-founder and co-director of the University of Colorado Center for Pharmaceutical Biotechnology. His research interests include mechanisms for protein degradation and stabilization in pharmaceutical formulations, delivery systems, and in human disease. Also, he has worked for several years to define rational strategies for stabilizing proteins during processing steps such as lyophilization. He has published more than 120 peer-reviewed papers and is an inventor on nine patents. He has received numerous teaching awards and is a Fellow of the American Association of Pharmaceutical Scientists. Dr. Carpenter serves as a consultant for numerous pharmaceutical and biotechnology companies.
Dr. Michael J. Pikal is Professor of Pharmaceutics at the University of Connecticut. His current research activities concern the solid-state chemistry of pharmaceuticals, particularly the stability of amorphous materials, characterization of solids by calorimetry, and the science and technology of freeze-drying with a focus on optimization of formulation and process for labile proteins. Dr. Pikal is the 1977 recipient of the American Pharmaceutical Association's Ebert Prize and the 1989 recipient of the PDA award for the best paper of the year. He was awarded the Eli Lilly & Company President's Award in 1996. Dr. Pikal is a Fellow of the American Association of Pharmaceutical Scientists and received the AAPS Research Achievement Award in Pharmaceutical Technologies in 2001. He was the Busse Lecturer at the University of Wisconsin in 1983 and the Enz Lecturer at the University of Kansas in 1998.
Dr. George Zografi is the Edward Kremers Professor of Pharmaceutical Sciences, School of Pharmacy, University of Wisconsin-Madison. Dr. Zografi's research interests are in the amorphous solid state, water-solid interactions, solid-state stability, wetting of solids, and the surface chemistry of phospholipids, proteins, and polymers. He has served on the editorial boards of the Journal of Colloid and Interface Science and of Pharmaceutical Research, and currently serves with the Journal of Pharmaceutical Sciences and the International Journal of Pharmaceutics. Dr. Zografi is a member of the Institute of Medicine of the National Academy of Sciences. He is the recipient of the American Pharmaceutical Association's Ebert Prize and its Achievement Award for the Stimulation of Research, as well as the Volwiler Research Achievement Award of the American Association of Colleges of Pharmacy. He also has received the American Association of Pharmaceutical Scientists' Distinguished Scientist Award and the Dale E. Wurster Award in Pharmaceutics.