Wenchang Ji

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UNLABELLED Prefilled syringes and autoinjectors are becoming increasingly common for parenteral drug administration primarily due to the convenience they offer to the patients. Successful commercialization of such delivery systems requires thorough characterization of individual components. Complete understanding of various sources of variability and their(More)
Characterization of a protein-device combination product over a wide range of operating parameters defined by end-user requirements is critical for developing a product presentation that is convenient for patient use. In addition to the device components, several product attributes, such as product rheology and product-container interactions, govern the(More)
This study uses on-line absorbance monitoring to evaluate cleanability of protein drug products. Characterization and validation of equipment cleanliness is a key requirement for a biopharmaceutical facility. A manufacturing-scale cleaning cycle has to be developed and validated for its ability to clean all of the equipment parts for a given soil. Cleaning(More)
The transfer of information between the drug product development and manufacturing organizations is fundamental to drug product commercialization. This information is used to characterize the productprocess interaction and ensure manufacturability, and to set operating ranges at fill/finish sites. Amgen has successfully commercialized drug products for(More)
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