Module 3 2019

Aims of CMC Development

➢ Ultimately to develop a product that is: o Stable (shelf-life > 24 months for oral; > 12-18 months for injectable biologicals) o Reproducible batch to batch (DS and DP) o Easily scalable if market demands (DS and DP) o Made by well-understood and well-controlled processes (DS and DP) o Is economic to manufacture to control cost of goods and hence reimbursement price

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