April 1, 2009
The fourth annual BioProcess International Analytical and Quality Summit offers a focused look at solutions and approaches to problems facing analytical scientists in product characterization, assay development, method validation and quality control. Separate conference tracks are dedicated to biophysical analysis, posttranslational modifications, and method validation — with an additional track to tie those fields to the need for improved product understanding associated with quality by design. This multitrack format allows you to customize your conference experience based on your personal job function and responsibilities and the needs of your organization.
New for 2009
Preconference Workshops: “Early Phase Characterization of Your Molecule” and “Planning and Risk Assessment for Analytical Qualification and Validation”
Conference Sessions: Analytical and Quality Leadership Keynote Forum … High Throughput Biophysical Analysis … Critical Quality Attributes Related to Posttranslational Modifications … Validation Issues in the use of Platformed Analytical Methods … Qualification and Validation of Challenging Assay Types … Understanding and Controlling Glycosylation … Characterization for Non-Antibody Protein Structures … What Does QbD Mean for the Analytical Side? … Analytical and Quality Impacts of New Directions for Bioprocessing
Our 2009 conference program features an exclusive Analytical & Quality Leadership Keynote Forum: offering you to the opportunity to hear analytical leadership perspectives from Amgen, Genentech, Genzyme, and Human Genome Sciences on how current trends in technology, regulatory expectations, new standards and key problem areas will impact your company’s CMC development programs.
Keynote Presentations
“Key Challenges and Trends in the Role of Analytics in Biopharmaceutical Development,” by Thomas Spitznagel, vice president of biopharmaceutical development at Human Genome Sciences, Inc.
“Regulatory Expectations for QbD-Based Filings,” by Drew N. Kelner, director of analytical and formulation sciences at Amgen Inc.
“Impact of the Changing Regulatory Landscape on Analytical Programs During the Product Lifecycle,” by Ron Taticek, director of regulatory CMC at Genentech, Inc.
“Whose Problem Is Post-Translational Modification? The Roles of Discovery, Cell Culture and Chromatography in Understanding and Controlling PTMs,” by Daotian Fu, senior director of bioanalytical development at Genzyme Corporation
A keynote panel discussion featuring director-level speakers from Amgen, Genetech, Genzyme, Biogen Idec and Human Genome Sciences is entitled, “Current Trends in the Analytical and Quality Functions: How Can We Invest Wisely and Realize the Benefits of Next Generation Technologies and Approaches?”
Highlights
Analytical leadership from Amgen, Biogen Idec, Genentech, Genzyme, and Human Genome Sciences provide perspectives on how current trends in technology, regulatory expectations, new standards, and key problem areas will affect your company’s CMC development programs. Learn the differences in characterization methods for non–antibody-based protein therapeutics such as enzymes, chemically modified (e.g., PEGylated), fusion, and domain proteins. And discover how to adapt analytical development activities as your company diversifies its product pipelines.
Case studies will demonstrate how advanced biophysical methods support improved excipient selection, more robust early phase formulations, and more predictive forced degradation studies. Position your analytical support to adapt to the new QbD-based manufacturing paradigm using assays and instruments to measure critical quality attributes, how design space will affect specification setting, and how regulatory filings may change. Understand the stages of qualification and validation from early development through postlicensure — and how each step can be used as a building block for successful late-stage validations and regulatory filings.
Early registration discounts are currently available. Please mention code B9188BPIFE when registering.
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