Because the manufacturing quality of Erwinaze is unreliable, Jazz must take several steps to review manufacturing and quality information provided by PBL. Jazz undertakes these additional activities to ensure the product provided to us for collection, which at that time is not suitable for release to patients, can be made suitable for patients. If product is confirmed suitable for release to patients, it then undergoes packaging, labelling and distribution (and, in some instances, review by Regulatory Authorities prior to release).
At Jazz, patients are our top priority and we are fully committed to doing what we can to make quality product available to patients. For further information, please click here to learn more.