Targeted development of biosimilar pharmaceutical products
Targeted development of biosimilar pharmaceutical products
Targeted development of biosimilar pharmaceutical products
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Defining the target!<br />
� Initial target definition (before project start):<br />
� Characterize originator-batches with extensive<br />
set <strong>of</strong> state-<strong>of</strong>-the-art methods<br />
� Develop bioassays reflecting MoA<br />
� First risk-assessment to evaluate CQAs<br />
� Refined target (during project):<br />
� Characterize additional originator batches<br />
� Broad quality ranges obtained during cell line /<br />
process dev. allow establishment <strong>of</strong><br />
correlations phys.-chem. ↔ bioactivity<br />
� Refine definition <strong>of</strong> CQAs<br />
18 | Thomas Stangler | EAPB SIG Regulatory Aspects for Bio<strong>pharmaceutical</strong>s | October 4th, 2010 | Business use only
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