A Regulatory and Analytical Approach to Biomolecular Impurities - November 07 - 08, 2006

A Regulatory and Analytical Approach to Biomolecular Impurities
November 07 - 08, 2006 | Crowne Plaza San Francisco Union Square, San Francisco, CA

Event Overview
Dear Analytical Scientist Professional,
The current strides being made in biomolecular research has created high levels of excitement among the scientific community; that excitement brings with it questions and concerns. These industrywide concerns are multiple, varied, and frightening. They exist because there are no clear-cut industry standards concerning regulatory expectations, reference standards, and analytical techniques.
Because biomolecules are so unique and varied, there is a lack of understanding as to what is required. Because of this variability, there are no clear-cut impurity test methods or allowable impurity limits. Since the FDA and other regulatory agencies cannot agree on allowable impurity limits, you must speculate as to what impurity levels the will allow, leading you to perform multiple costly and time-consuming analytical tests to ensure their biomolecules meet changing regulatory requirements.
The varying analytical techniques, both the established and the cutting-edge, which are available to detect and separate biomolecular impurities, are creating more problems than they are solving. With no standard techniques, you must test by trial and error. Additionally, because one test cannot determine every impurity, it forces you to employ multiple techniques and piece the results together.
At the 2nd Annual Regulatory and Analytical Approach to Biomolecular Impurities conference, we bring together industry, academic and government experts in the field of biomolecular impurities to discuss proven techniques, case studies, and bestpractices for testing and establishing impurity limits. This conference serves as a forum to meet with experts to discuss experiences and identify best practices. With an emphasis on sharing experiences, the program is dedicated to real-life applications while brainstorming sessions aim to accomplish this. This conference also provides a high level of regulatory guidance ranging from reference standard variability to clinical trial submission. The regulatory experts presenting at this conference provide insight into expectations and goals for the future.
November 7, 2006: Main Conference Day One
On day one of the event, we begin with an inclusive tutorial on aggregation and stability. These sessions serve to strengthen your understanding of how aggregates form, why they are a cause for concern and how you can prevent them. The afternoon discusses types of impurities and provides in-depth information on current regulatory questions and answers.
November 8, 2006: Main Conference Day Two
Day two of the event kicks off with sessions on assay development. We then explore various technologies used to characterize impurities in biomolecules. Day two addresses novel advances in the field, such as Analytical Ultracentrifugation and Light-Scattering technology. Day two concludes with sessions on analytical strategies to satisfy regulatory agencies and developing a stability program for protein products.
Breakout sessions, networking luncheons, and case studies make this conference a MAJOR NETWORKING OPPORTUNITY for the biomolecular sciences community.
We hope you will join us for this truly rewarding and educational experience!
Sincerely,
Mary Cromwell
Scientist and Senior Group Leader
GENENTECH
Timothy Hayes
Director of Analytical Chemistry
AMERICAN RED CROSS
Tricia Carle
Conference Producer- Pharmaceutical & Biotech Division
IIR
Valerie Bowling
General Manager, Pharmaceutical & Biotech Division
IIR
Who Should Attend
This event is specifically designed for Analytical Scientists from pharmaceutical and biotech companies of all sizes. This event is planned for scientists with responsibilities in analytical development, formulation, process development, quality control, and regulatory affairs with the following titles:
? Analytical Chemists
? Analytical Development
? Research Scientists
? Bioanalytical Scientists
? Research Associates
? Formulation Scientists
? Process Development Scientists/Engineers
? Development Scientists
? Team Managers/Group Leaders
Why You Should Attend
Key Deliverables
? Optimizing circumstances to prevent aggregation and degradation
? Learn how to perform a stability test and what kind of documentation is required
? Determine the challenges in isolating impurities
? Examine monoclonal antibodies and their extremely unusual charge
? Mastering distinctive purification methods
? Using statistics to analyze impurity levels and set specifications
? Managing costs while developing reference standards
? Compare Light Scattering analysis with other technologies for characterizing impurities in biomolecules
? Explore different ways to look at the PEG and see how it interferes with classical approaches to detect and analyze PEGylated proteins
? Analyze the impact of changes in process operating conditions on clearance of pathogenic impurities
? Access improved impurity detection reagents for quantitative analysis
? Investigate strengths and limits of protein assays
? Explore regulatory requirements for biomolecule impurity testing