Short Courses

Monday, August 19, 2013

8:00am  Short Course Registration and Morning Coffee

8:30 - 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
• Oxygen
• Providing optimal conditions
• Process optimization
• Analytical tools
• Increasing cell densities
• High-throughput protocols

Instructors:
 

Steven Chamow, Ph.D., Biopharmaceutical Consulting, Chamow & Associates, Inc.
Yao-ming Huang, Ph.D., Principal, BioPharm Development Engineer, Biogen Idec, Inc.
Karlheinz Landauer, Ph.D., Chief Operating Officer, Operative Departments, Celonic AG

Martin Jordan, Ph.D., Scientist, Biotech Process Sciences - Medium Development, Merck Serono SA

Brian Posey, Ph.D., Product Development Manager, Corning Life Sciences
 

SC 2: Tackling and Overcoming Challenges in Protein Expression 

When challenges arise in protein expression, it helps to turn to the experts for advice and help. This course is designed to address problems that are commonly encountered, and includes the opportunity to bring your challenges to the experts for addressing solutions to the problems you wrestle with in your group. Bring your issues for discussion.

• Protein Expression in Different Platforms
  • - E.coli 
  • - Baculovirus
  • - Mammalian
   
• Expression troubleshooting
• Unique challenges and needs
• Protein quality
• Best practices
• Purification challenges
• Tailor-Made Solutions

Instructors:

James Groarke, Ph.D., Chief Scientific Officer, Biortus Biosciences

Dominic Esposito, Ph.D., Director, Protein Expression Lab, SAIC Frederick
Additional Instructors to be Announced

SC 3: Sub-Visible Particle Analysis in High-Concentration Protein and Viral Formulations 

The need to monitor, measure and control sub-visible particulates in biopharmaceutical formulations has been emphasized in recent publications and comments by regulators. Some of these particulates can be highly transparent, fragile and unstable. In much of the size range of concern, a practical measurement method with adequate sensitivity and repeatability has been difficult.

• Development and qualification of a method or complementary methods for sub-visible particle counting for a high-concentration protein formulation
• Overcoming the issues inherent in high-concentration formulations and container-closure systems
• Understanding the latest tools, technologies and methodologies
• How to ensure the resulting method is robust, reproducible, and suitable for use in a QC environment

Instructors:

Danny Chou, Ph.D., Senior Research Scientist, Biologics Development, Gilead Sciences, Inc.

Marina Kirkitadze, Ph.D., MBA, Deputy Director, Head, Biophysics and Conformation Unit, Biochemistry Platform Analytical R&D North America, Sanofi Pasteur Ltd.

SC 4: Strategies for Development of Analytical Specifications 

This short course will discuss the strategies for development of analytical specifications and in assuring quality of a biotherapeutic drug product. Course will also cover FDA guidance and expectations, and addressing out-of-specification (OOS) results in a timely and productive fashion.

• Defining and setting up analytical specifications
• Statistical approaches to setting analytical specifications
• Selection of analytical assays to include in specifications
• Determining specifications based on critical quality attributes
• Handling of OOS results and how these occurrences can be minimized
• Identification and investigation of critical deviations or a failure of a batch to meet its specifications or quality standards
• Quality assurance system to ensure corrective and preventative action plans for OOS results follow-up

Jonathan Basch, Senior Scientist, Process Development Analytics and Commercial Support, Bristol Myers Squibb Co.

Additional Instructors to be Announced

Tuesday, August 20, 2013

5:15pm  Dinner Short Course Registration

6:00 - 9:00pm Dinner Short Courses

 SC 5: E.coli Innovations - Detailed Agenda  

Escherichia coli has proven its worth as a protein expression platform. Currently, E.coli is not viewed so much as an ‘alternative’ platform, but as a viable choice for achieving high-level expression of human genes and protein at a reasonable cost. This Dinner Short Course will explore strategies for successfully producing protein in E.coli, including:

• host cell engineering to improve product quality
• development of protein expression assays
• development and optimization of protein purification processes
• automating high-throughput protein expression and purification
• scaling up production

Instructors:

Susanne Dilsen, Ph.D., Head, Production, Wacker Biotech GmbH

David P. Humphreys, Ph.D., Director, Antibody Biology, UCB-New Medicines
Trevor Hallam, Ph.D., Chief Scientific Officer, Sutro Biopharma, Inc.
Additional Instructors to be Announced

SC 6: Accelerated Stability Testing of Biologics  

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
  • Oxidizers
   

• Developing predictive and correlative tools: utility, desired features and examples

• Excipients
  • Degradation mechanisms
  • Impact on protein stability
  • Factors to consider during stress/accelerated testing
   

• Primary packaging
  • Accelerated stability testing
  • Extractable/leachables
   

Instructor:

Yatin R. Gokran, Ph.D., Narotam Sekhsaria Distinguished Professor of Chemical Engineering, Institute of Chemical Technology, Mumbai, India

Thursday, August 22

5:15pm Dinner Short Course Registration

6:00 - 9:00pm Dinner Short Courses

SC 7: Transient Protein Production in Mammalian Cells 

This short course will introduce both the fundamental concepts and technologies needed to establish transient protein production in mammalian cells. This will allow for the rapid generation of milligram to gram quantities of secreted or intracellular recombinant proteins for therapeutic, functional, and structural studies. The course will combine instruction and case studies in an interactive environment. What you will learn:

• A brief overview and comparison of protein expression systems
• An in-depth introduction to mammalian transient expression systems
• Examination of the key elements necessary for the establishment of a mammalian transient production system
• Scaling transient protein production to accommodate a wide range of recombinant protein requirements
• Optimizing the transient protein production process

Instructors:

Henry C. Chiou, Ph.D., Senior Manager, Product Development, Life Technologies

Richard Altman, MS, Research Scientist, Alexion Pharmaceuticals

Additional Instructors to be Announced