Module 9 2024

03/09/2024

…together with the production process and its control

Key learnings

• The upstream process is where our product is made

• Upstream conditions impact on product titre, product quality and impurities and conditions must be controlled. Link between process parameters and quality attributes • Downstream process is necessary to remove process impurities, cell matter, cell DNA and proteins, process reagents (antifoam)

• Steps included in the downstream process to also remove PRODUCT related impurities, aggregates, undesired charged/hydrophobic variants, viruses

• The process must be validated prior to marketing authorisation to show consistent production of the desired product

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You might be forgiven for thinking that

‘The

Process Is The ProducT’

The Organisation for Professionals in Regulatory Affairs

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