TECHNOLOGY TRANSFER OF STERILE PROPDUCTS - IIR
TECHNOLOGY TRANSFER OF STERILE PROPDUCTS - IIR
TECHNOLOGY TRANSFER OF STERILE PROPDUCTS - IIR
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Technology Transfer for Lyo Product Manufacturing<br />
(Scale up Issues, Phase III and Commercial)<br />
Phase III lyo cycle validation -final formulation/packaging<br />
– contd.<br />
‣ Target cycle: 3 val batches for one lyo chamber & matrix val<br />
batches for multiple lyo chamber Phase III mfg (needs FDA OK)<br />
‣ Place all three validation batches on stability<br />
‣ Analyze TC data for intra-batch and inter-batch consistency<br />
‣ Analyze temperature and chamber pressure data for each batch<br />
vs. established boundary parameters for lyo cycle<br />
‣ Individual TC vs. average TC data for each and all batches<br />
Extensive characterization for critical parameters<br />
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