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 />
Stage: Scale up from Phase II to Phase III and<br />
Registration Batches to Commercialization<br />
Product: Lyophilized, aqueous solution, biomolecule<br />
Phase I, II DP (e.g., 50 sq. ft lyo)<br />
Phase III and Commercial DP (e.g., 290 sq. ft)<br />
Label claim change: from 40 mg/100 cc to 40 mg/60 cc and 80<br />
mg/100 cc vial (to increase yield/reduce COG).<br />
May need formulation change for lyo fill volume adjustment<br />
(1mg/mL to 2mg/mL). Assume it’s s done.<br />
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