Module 3 Presentations

14/05/2024

Product Development Needs

Desirable Characteristics  Simple DS synthesis from

Undesirable Characteristics  Complex synthesis using expensive reagents and/or difficult reactions (= costly)  Constrained manufacture reliant on sub-contractors or difficult to scale reactions (eg highly exothermic or explosive). GMP concerns?  Cold Chain (or worse frozen) storage and distribution unless critical (vaccines etc)

readily available compounds and ‘easy’ reactions; simple DP formulation and packaging

 Scalable with ease (both DS and DP) to cope with market demand (no out of stock situations)  Stable at ambient temperatures for oral dosage forms

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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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