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Well Characterized Biologicals
 
QA-Bio, LLC
128 Vista Monte
Palm Desert, CA 92260
 
 
Well Characterized Biologicals
 
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<p align="center" style="margin-bottom: 0px;"><b>Did you know that QA-Bio will be exhibiting at the following event?<br>
We hope you can join us at one of these conferences, and are proud to offer you our special 25% discount.</b></p>
<p align="center" style="margin-top: .5em;"><i>Please use the link below to view the discounted pricing.</i></p>
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<p align="center" style="font-family: times new roman, times, serif; font-size: 2em; padding: 3px; background: #663399; color: #eeeeee; font-weight: bold;">Well Characterized Biologicals</p>
<p>November 10-12, 2008 &#183; Hyatt Regency Reston &#183; Reston, VA</p>
<p><i>Continuous Evolution of Analytical Approaches - Advancing the State of Understanding for Protein Characterization</i></p>
<p><a href="http://www.ibclifesciences.com/wcb">Event Website</a><br>
<a href="http://www.ibclifesciences.com/wcb/brochure.xml">Download the Brochure</a><br>
<a href="http://www.ibclifesciences.com/wcb/index.xml?registration=B8193QAB">View Discounted Pricing</a></p>

<p><span style="color: #663399;"><b>Regulatory Keynote Address</b></span><br>
<b><i>Using Quality by Design (QbD) for Biotechnology Products - What are the Unique Considerations and How can QbD Enhance the Development of Biotechnology Products?</i></b><br>
Steven Kozlowski, Ph.D., <b>CDER, US FDA</b></p>

<p><span style="color: #663399;"><b>Featured Regulatory Presentations</b></span><br>
<b><i>Characterization of Oversulfated Chondroitin Sulfate in Heparin and its Association with Adverse Clinical Events</i></b><br>
Ali Al-Hakim, Ph.D., <b>CDER, US FDA</b>

<p><b><i>FDA's Perspective on Demonstrating Comparability for Biosimilar Products</i></b><br>
Emily Shacter, Ph.D., <b>CDER, US FDA</b></p>

<p><b><i>An FDA Perspective on the Development of Appropriate Potency Assays for Biopharmaceutical Products</i></b><br>
Carla S. Lankford, M.D., Ph.D., <b>CDER, US FDA</b></p>

<p><b><i>Product and Process-Related Impurities and their Impact on Product Quality - An FDA Perspective and Recommendations</i></b><br>
Barbara Rellahan, Ph.D., <b>CDER, US FDA</b></p>

<p><b><b>Necessity of Change for Plasma and Recombinant Products</b></b><br>
Roman T. Drews, Ph.D., <b>CBER, US FDA</b></p>

<p><b>TO REGISTER</b><br>
<b>Online:</b> <a href="http://www.IBCLifeSciences.com/WCB/index.xml?registration=B8193QAB">www.IBCLifeSciences.com/WCB</a><br>
<b>Call:</b> 800.390.4078<br>
<b>Fax:</b> 941.365.0104<br>
<b>Email:</b> <a href="mailto:reg@ibcusa.com?subject=WCB Registration">reg@ibcusa.com</a><br>
<b><i>Priority Code: B8193QAB</i></b></p>


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