Monitoring Batch to Batch API Consistency

During the development process, the drug or product manufacturing process often goes through a number of changes.

For manufacturers, it is important to accurately measure material characteristics and monitoring quality, as it is essential for understanding risk.

Tracking changes can provide useful information later in development.

Merlin has worked with various companies, generating compactibility and compressibility assessments on batches of API from different campaigns to monitor for changes in compaction behaviour, creating a historical record of physical properties relating to manufacturability.