Module 9 2024

03/09/2024

What happened on the journey?

Early on, it dawned on us that:

Manufacturing technology was facile

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– Extraction with little or no processing

– Collection and fractionation

– Expansion/culture and modification

• High dependence on facility and raw materials

Minimal analysis

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• Inconsistency/quality attributes not detectable

Manufacturing errors unchecked

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• Biological activity/potency determined utility

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Early in the journey

Consequential conclusions

• Realisation of attributes of biological products and their variability

Awareness of serious hazards

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• Importance of consistency in manufacture through analysis

• Recognition of need for controls on raw materials, process and facility to reduce risk

• Concept of Quality; using well-controlled ingredients to manufacture a product of consistent standard

regulation

Concept of oversight: the birth of

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