Monday, August 18, 2014
Pre-Conference Short Courses
9:00 - 11:30am
SC 1 Optimizing Media – Achieving Super Soup - Detailed Agenda
To grow mammalian cells, researchers need to provide an optimal in vitro environment. The key feature of successful cell growth is the culture medium. ‘Achieving Super Soup’ requires finesse and know-how in order to combine the right ingredients at the right times under the right conditions to achieve high titers. This workshop will provide a foundation for optimizing cell culture media presented by real-world experts who will also tailor a portion of the course to fit concerns and challenges faced by the workshop participants.
- Feed strategies
- Media formulation
- Providing optimal conditions
- Process optimization
- Analytical tools
- Increasing cell densities
- High-throughput protocols
Kamal Rashid, Ph.D., Director, Biomanufacturing Education and Training Center, Worcester Polytechnic Institute
Alan G. Ryder, Ph.D., Senior Lecturer, Nanoscale Biophotonics Laboratory, School of Chemistry, National University of Ireland-Galway (NUIG)
Seshu Tummala, Ph.D., Senior Scientist, Manufacturing Sciences and Technology Group, Lonza Biologics, Inc.
SC2 QbD Strategies for Formulation Development of Protein Therapeutics - Detailed Agenda
This course offers a forum, discussing how to perform protein drug formulation development to meet Quality by Design expectations from the health authorities. A number of case studies will be presented to demonstrate how to design multivariate experiments, how to obtain dataset and how to analyze data in order to propose formulation of drug substance or drug product. The course will combine “how to” suggestions and real-world examples in an interactive discussion.
The topics to be covered:
- QbD: Protein formulation strategies for regulatory filings
- Force degradation and stability-indicating analytical methods
- Application and utility of Design of Experiment (DoE) studies during early phase formulation development
- Case studies: Multivariate analysis of data table
- Design space of protein drug formulation
Steven LaBrenz, Ph.D., Scientific Director, Drug Product Development, Janssen R&D
Kevin Zen, Ph.D., Manager, Biologics Development, Allergan
SC 3 Operational Excellence in Bioprocessing: PAT, QbD, DoE and Continuous Improvement - Detailed Agenda
Ensuring quality in bioprocesses that complies with regulatory requirements and mitigates risk often results in very high bottom-line costs. Adopting best practices early in the development process and customizing these approaches to operational excellence from other highly competitive industries are currently taking place in biopharmaceutical production. This course will provide both an overview of these approaches and how they work, as well as case studies of how these innovations have been applied successfully in bioprocessing and the development of biopharmaceuticals. Appropriate regulatory guidance will also be discussed.
- Quality by Design (QbD)
- Design of Experiment (DoE)
- Process Analytical Technology (PAT)
- Continuous Improvement
- Lean Manufacturing
- Six Sigma
James Blackwell, Ph.D., M.B.A., President, The Windshire Group, LLC
Ambarish Singh, Ph.D., Director, Chemistry Manufacturing & Control, Bristol Myers Squibb Co.
SC 4 ADC “Developability”: Critical Quality Attributes Inform Formulation and Process Development - Detailed Agenda
ADCs have unique critical quality attributes (CQAs) that are affected by the nature of the component parts: the antibody, the linker and the toxin. The CQAs are also strongly affected by the formulation, the process parameters, and the storage conditions. Effective formulation and process development strategies are based upon a molecular understanding of ADC CQAs: aggregates, charge variants, drug antibody ratio, conjugation site, free drug. Development of these complex molecules requires an array of analytical and biophysical techniques that are used to identify attributes that could have a clinical impact.
In this short course, the attendee will learn:
- Characterization tools to inform rational ADC development
- Intrinsic molecular attributes: Consideration of the mAb, linker and payload
- Degradation pathways of ADCs
- Extrinsic factors that affect CQAs: Formulation and process design
Janet Wolfe, Ph.D., President & CEO, Wolfe Laboratories
Tuesday, August 19, 2014
DINNER SHORT COURSES (includes Dinner)
6:00 – 8:30pm
SC 5 Extractables & Leachables: Study Design for Disposables and Qualification Consideration
Along with reviewing the history of E&L study designs, this course will also clarify the differences between designing E&L studies for disposable versus primary packaging, and how to use supplier data. We will also look at container closure integrity tests, and discuss E&L test methods development and validation. Finally, we will assess strategies for simplifying and reducing the numbers of E&L studies required, especially with specification changes.
- History of E&L study designs
- Understand key differences between E&L study designs for disposable and primary packaging
- How to leverage supplier data?
- Levels of supplier’s data quality
- Extractable study design consideration
- Leachable study design consideration
- How to simplify and reduce numbers of E&L studies?
Ken Wong, Deputy Director, MTech/AP&T - Extractables & Leachables, Sanofi Pasteur
SC 6 Accelerated Stability Testing of Biologics - Detailed Agenda
This short course will aim to guide the researcher in designing studies for accelerated stability testing of biologics. The course will begin with basic underlying concepts governing protein drug product stability, and focus on design principles for meaning stress and accelerated stability testing of not only the protein of interest, but also of excipients and primary packaging components. Strategies to handle complexities arising from their interactions will also be discussed.
- Attributes of a successful protein drug product
- Modes of protein degradation: Conformational stability, colloidal stability and chemical stability
- Chemical degradation reaction
- Real-time/accelerated/stress stability testing: Rational design of stability conditions
- Stressors for evaluating protein stability
- Temperature: Arrhenius and non-Arrhenius kinetics
- pH: Coupled effects of pH and buffers
- Interface: effects of protein stability: solid/liquid, liquid/liquid and liquid/gas
- Developing predictive and correlative tools: utility, desired features and examples
- Degradation mechanisms
- Impact on protein stability
- Factors to consider during stress/accelerated testing
- Primary packaging
- Accelerated stability testing
Yatin R. Gokarn, Ph.D., Narotam Sekhsaria Distinguished Professor of Chemical Engineering, Institute of Chemical Technology, Mumbai, India
SC7 Analytical Strategies for Comparability in Bioprocess Development
Bioprocess changes can impact quality attributes of biologics and may affect efficacy and/or safety of the product. During development and throughout the product lifecyle, when process improvements are implemented, it is essential to gather sufficient data to support the conclusion that product safety or efficacy has not been adversely affected. This demonstration exercise requires careful planning of the comparability studies and is based on the background knowledge of protein structure, biological function, and clinical attribute profiles of the product accumulated during development.
In this short course, we will discuss the key concepts of defining critical product quality attributes, the common analytical characterization technologies used, considerations in process monitoring and controls, and the iterative process of demonstrating comparability of the product in support of process changes.
- Defining product critical quality attributes and stability profile during development
- Analytical characterization strategies: Common biochemical, biophysical and potency assays; and emerging tools. Conducting forced degradation studies and long-term stability studies. Selection of test methods and acceptance criteria.
- Bioprocess impact on product quality; defining process control strategy
- Hierarchical approach to comparability assessment: Types of manufacturing changes and risks
- ICH guidance documents, practical examples and discussions
Instructor: Christine P. Chan, Ph.D., Principal Scientist/Technical Lead, Manufacturing Science & Technology, Genzyme, a SANOFI company
Thursday, August 21, 2014
Dinner Short Courses
6:30 – 9:00pm
SC8: Biophysical Characterization in Developing Biopharmaceuticals: The Path to Developability, Stability and Comparability - Detailed Agenda
This interactive dinner course will take a closer look at the biophysical toolbox and approaches for monitoring the higher order structure (HOS) of protein drugs to:
- Assess their physicochemical properties for drug candidate and formulation selection
- Develop their HOS fingerprint
- Detect changes in their HOS during development
- Characterize their variant forms
- Monitor aggregation
Steven Berkowitz, Ph.D., Consultant; formerly Senior Principal Scientist, Analytical Development, Biogen Idec
SC 9: ABC: Anything But Chromatography – Precipitation, Crystallization and Flocculation - Detailed Agenda
Increased titer in biopharmaceutical production requires new strategies for economical processing. Precipitation, crystallization and flocculation are a unit operation which overcomes productivity limits of chromatography. General engineering principles, including how to set up a precipitation, crystallization, or flocculation process for purification of recombinant proteins will be shown. Scale up rules will be explained. Examples will be shown for products produced in mammalian cell culture and E.coli. A strategy on how to implement such processes will be discussed.
- Overcoming productivity limits of your current process
- Design of a cost effective, scalable process
- Streamlining your existing process
- Precipitation, crystallization and flocculation is a platform technology
Alois Jungbauer, Ph.D., Professor, Department of Biotechnology, University of Natural Resources and Life Science Vienna, (BOKU) and Austrian Centre of Industrial Biotechnology
SC 10: Bioprocess Development: Considerations for the Quality and Safety of Materials in Contact with Biologics - Detailed Agenda
- The Types of Materials Used in the Manufacture and Storage of Biologics
- The Regulatory Landscape: CBER, ICH, USP, PQRI
- Understanding Material Chemistry: Plastic, Rubber, Glass and Metals
- Manufacturing Components- Single-Use and Disposables
- Container Closure Components/ Primary Systems
- Interaction of Biologics with Product Contact Materials: Yeild, Leachables, Protein Stability
- Closing Remarks and Future Perspective: Where Are We Now and Where Are We Going
Diane Paskiet, Ph.D., Director, Scientific Affairs, West Pharmaceutical
Jeffrey Carter, Ph.D., Regulatory Strategy Leader, GE Healthcare