Institute for International Research

IBC's 4th annual BioProess International Analytical & Quality Summit took place on May 4-6, 2009 in California. This three-day conference gave attendees a focused look at the solutions and approaches to problems facing analytical scientists in the areas of product characterization, assay development, method validation and quality control.

Four separate conference tracks were dedicated to biophysical analysis, post-translation modifications and method validation - with and addition track to help ties these analytical fields to the need for improved product understanding associated with quality by design.

Program highlights included:

• Analytical leadership perspectives from Amgen, Biogen Idec, Genentech, Genzyme and Human Genome who provide insights into how the current trends in technology, regulatory expectations, new standards and key problem areas will impact CMC development programs.
• Sessions that highlighted the differences in characterization methods for non-antibody based protein therapeutics (enzymes, chemically modified (e.g. PEGylated), fusion or domain proteins), and how to adapt analytical development activities as your company diversifies its product pipelines
• Case studies that demonstrated how advanced biophysical methods support improved excipient selection, more robust early phase formulations and more predictive forced degradation studies
• Learning how to 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 impact specification setting, and how regulatory filings may change
• Understanding the stages of qualification and validation from early development through post-licensure - and how each step can be used as a building block for successful late stage validations and regulatory filings

Plus, attendees were able to choose from two pre-conference workshops offering them practical strategies they could apply immediately to reduce their time and expense of analytical development programs.

• Early Phase Characterization of Your Molecule
• Planning and Risk Assessment for Analytical Qualification and Validation

Planning is now underway for 2010 - join the priority contact list for latest updates and announcements on next year's program.