Early Implementation of QbD in Biopharmaceutical Development: A Practical Example

<table class="table-group" id="tab2"><tr><td><table class="table"><tr><td class="thead-hr" colspan="3"><hr/></td></tr><tr class="thead"><td align="left">QTPP</td><td align="center">CQA</td><td align="center">Design criteria (Developability)</td></tr><tr><td class="thead-hr" colspan="3"><hr/></td></tr><tr><td align="left">Increase therapeutic index<br/>Reduce dosage</td><td align="center">Extended half life</td><td align="center">Increase product size (passive)<br/>Fuse/conjugate to “carrier”</td></tr><tr><td align="center" colspan="3"><hr/></td></tr><tr><td align="left">Safety to patient<br/>Minimise resistance to drug</td><td align="center">Low immunogenicity</td><td align="center">Eliminate T cell epitopes<br/>Minimise aggregation</td></tr><tr class="table-tr"><td colspan="3"><hr class="tbody-hr"/></td></tr></table></td></tr></table>

QTPP, CQA, and design criteria derived for case study 2. The main criteria considered in this particular example revolve around pharmacology and safety requirements for the final product.

BioMed Research International

tab2

Table 2

Table 2: Early Implementation of QbD in Biopharmaceutical Development: A Practical Example 