The 4th Annual Analytical Method Validation gives assay development and validation scientists a wide view of how qualification and validation activities are performed across the industry. You will learn about timing and resource allocation at each step, receive updates on key regulatory and standards initiatives and learn how to optimize your method transfers. - Wyeth demonstrates a set of novel timing strategies to help accelerate analytical development and validation for a protein therapeutic
- Medarex shows you how to overcome the challenges in validating peptide map assays during early and late phases of biologics development
- Eli Lilly and Company presents a case study of a bioassay validation protocol containing parameters and acceptance criteria derived from both bioassay and statistical perspectives - and the subsequent method transfer to a global site
| The 2nd Annual Biophysical Analysis for Bioprocessing provides experienced analytical scientists a set of important case studies showing how advanced analytical methods (including DLS, FFF, Static Light Scattering and AUC) are being used alone and together to characterize proteins and achieve greater product stability. - Rensselaer Polytechnic Institute outlines a computational approach that enables the engineering of proteins with enhanced stability by rational redesign of protein surfaces
- Pfizer describes a valuable tool for formulation development that can identify potential markers for physical and chemical instabilities in biologics using sequence and structure information
- Abbott helps you improve your analytical results by showing how capillary electrophoresis and analytical ultracentrifugation are used to strengthen traditional PAGE and SEC analysis of monoclonal antibodies
| Process Characterization and Control, IBC's 5th annual process quality forum, builds on four years of PAT and QbD events to offer you a conference full of case studies demonstrating how process understanding is used to improve product quality across unit operations. - Genentech and Biogen Idec share perspectives from their experiences in integrating QbD-based programs into their organizations
- Regeneron presents a case study of how modifications of clarification processes impacts the outcome of purification processes
- MIT describes the results of a comparative study between samples from an automated sampling system and manually acquired samples - demonstrating how automation in cell culture process development can impact product quality
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| Interdependence of Product Characterization, Analytical Method Validation, and Comparability Assessment
Chulani Karunatilake, Ph.D., Director, Analytical Sciences, Amgen, Inc. Applying Quality by Design Principles to Assay Development and Validation
Dieter Schmalzing, Ph.D., Associate Director, Genentech, Inc. | New Methods for Characterization of Protein Aggregation Tudor Arvinte, Ph.D., Professor, Department of Pharmaceutics and Biopharmaceutics, School of Pharmacy, University of Geneva, Switzerland The Application of Novel Biophysical Methods for Drug Development
Jun Liu, Ph.D., Senior Scientist, Genentech, Inc. | Quality by Design in Biotechnology: Why and How?
Gail Burnett, Ph.D., Senior Director of Quality Bioanalytical Development, Genentech, Inc. Application of QbD for Development and Manufacturing of a BioPharamaceutical
Rohin Mhatre, Ph.D. Director, Bioprocess Development, Biogen Idec, Inc. |
| Attend one of three focused pre-conference workshops: - The Principles and Application of Design of Experiments in Bioprocessing - A Hands-On Course (Instructors from Eli Lilly and Company, Human Genome Sciences, the SAS Institute and Talecris)
- Oligomerization and High Molecular Weight Species Determination - Understanding and Meeting Current Regulatory Requirements (Instructors from Biogen Idec, the Biologics Consulting Group, NIST, Wyatt Technology, Wyeth and Yale University)
- Best Practices for Working with Contract Organizations for Analytical Support (Instructors from Biogen Idec, BioProcess Technology Consultants, Cato Research and KBI Biopharma)
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| Founding Publication:
 BioProcess International™ is concerned with the application of biotechnology to industry, particularly to the development and manufacture of biopharmaceutical applications including: proteins, peptides, hormones, vaccines, oligonucleotides, gene therapies, cell and tissue therapies and biodiagnostics. BioProcess International™ provides biotechnology vendors with the most effective, most cost efficent print and online access to 30,032 biotherapeutic decision makers working throughout the world. BioProcess International's advertisers are the leading suppliers of equipment, technologies, contract & consultant services and materials necessary for biotherapeutics companies to complete each phase of the biodevelopment process in the most timely, successful and economic matter. To learn more about BioProcess International™, please visit www.bioprocessintl.com |
