The recent success of pharmaceutical innovation and the record level of new FDA approvals is driving a vibrant contract development and manufacturing industry (CDMOs). This success, though, must be placed in a broader context to fully appreciate and understand the profound changes that have taken place.
Almost half of the new chemical entities (NCEs) have been designated as orphan drugs, which means they’ll be produced in modest to low volumes. Yet, compared with past blockbusters, many of these new NCEs require a longer convergent or linear route of synthesis. As such, regulators are demanding more cGMP stages and want to implement the regulatory starting materials (RSM) strategy earlier.
Overlay ICH Q11 and the genotoxic impurity (GTI) guideline (M7) and you see a dramatic increase in the generation of data and know-how, experimentation, method development and impurity/GTI tracking. Plus, capacity (size and scale) saturation occurs more quickly now because of the higher number of changeovers. And, finally, compliance for NCEs is made easier and more cost-effective by controlling impurities at the RSM stage.
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