TECHNOLOGY TRANSFER OF STERILE PROPDUCTS - IIR
TECHNOLOGY TRANSFER OF STERILE PROPDUCTS - IIR
TECHNOLOGY TRANSFER OF STERILE PROPDUCTS - IIR
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Hypothetical Technology Transfer<br />
(Scale up Issues, Phase III and Commercial)<br />
Process Validation Strategy - DP Related<br />
(multiple lyo loads)<br />
‣ Comparability of data between different scales<br />
‣ Hold time for all critical segments of mfg proc<br />
for longest possible periods<br />
‣ Mixing (Target and ± speed, Target and ± time)<br />
‣ Lyophilization characterization: moisture,<br />
bioactivity, SDS-PAGE, RP-HPLC, IEF, FTIR,<br />
DSC, SEC, Sub-visible particles through out<br />
chamber for all batches (biomolecule)<br />
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