Regulatory Aspects of Impurities in Biological Products - IIR
Regulatory Aspects of Impurities in Biological Products - IIR
Regulatory Aspects of Impurities in Biological Products - IIR
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CMC Strategy Forum July 2004<br />
Gold Sheet Vol. 38 No. 9 September 2004<br />
F-D-C Reports<br />
http://www.thegoldsheet.com/FDC/monthly/gold/PrevMenu.htm<br />
CMC Strategy Forum White Papers (BioProcess<br />
International) Def<strong>in</strong><strong>in</strong>g Your Product Pr<strong>of</strong>ile and Keep<strong>in</strong>g<br />
Control Over It<br />
http://www.bioprocess<strong>in</strong>tl.com/default.asp?page=cmc<br />
Part 1: Simmerman and Donnelly (June 2005) Process Related<br />
<strong>Impurities</strong><br />
Part 2: Champion, Madden, Dougherty, and Shacter (Sept 2005)<br />
Challenges <strong>of</strong> Monitor<strong>in</strong>g Host Cell Prote<strong>in</strong> <strong>Impurities</strong><br />
Part 3: Boerner and Clouse (Oct 2005) Product Related<br />
<strong>Impurities</strong><br />
Part 4: Broerson and Phillips (Nov 2005) Product Related<br />
<strong>Impurities</strong>: Tackl<strong>in</strong>g Aggregates
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