Batch-to-batch comparability and Biosimilars
Differential Scanning Calorimetry (DSC) is used in research and development to identify biotherapeutics with good stability potential and to determine the conditions that maximize a biological product’s shelf-life. It also has a role in manufacturing, where it supports the robust demonstration of batch-to-batch comparability of any biologics, or the comparability of an innovator product with a biosimilar product.
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Troubleshooting and root cause analysis
An out-of-specification product requires investigation to understand the cause of the manufacturing issue and prevent any recurrence. This requires referencing the final dosage form back through the processes involved in its creation, to establish where the problem lies.
Biophysical characterization techniques play a key role in determining if and where there are issues with aggregation, for example, or in determining contamination sources.