Vetter Pharma International - High-Quality Aseptically Pre-Filled Injection Systems Case Studies

Know-how Technology Transfer from R&D to Manufacturing Each product needs to be transferred from R&D scale to commercial manufacturing scale. This requires precise pro- ject planning at an early stage, a competent project team, a sophisticated application system and a filing strategy which meets the time-to-market approach. This example shows a freeze-dried dual-chamber system introduced in clinical phase III and transferred to a third-party manufacturer. The different planning steps and milestones with respect to key questions, conditions, results and further actions are discussed.
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Speeding Up Time-to-Market By leveraging its expertise and precise planning capabilities, Vetter helps a client erase months from the development of packaging processes.
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Uncertainty in Process Control – The Limit of Setting Limits Although test procedures used in pharmaceutical quality control have to be validated, these validation experiments are usually performed in early development stages in special laboratories using special equipment by specially skilled analysts. This may lead to an underestimation of the procedure´s variability and the setting of inappropriate – in most cases too tight – specification limits.
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