For the latest updates regarding the supply of ERWINAZE® (asparaginase Erwinia chrysanthemi), please visit ERWINAZEsupply.com
Due to quality and manufacturing issues with product manufactured by PBL over the past few years, product made available to Jazz by PBL is not ready for release to patients. Jazz needs to perform the following activities to ensure the suitability of the product for patients:
  • Conduct Good Manufacturing Practice (GMP) investigations
  • Conduct product quality assessments
  • Investigate product manufacturing deviations
  • Review and assess batch documentation
  • Ensure each batch meets global regulatory requirements
In addition, many batches have additional and specific quality and/or manufacturing issues that require additional activities and time to ensure product is suitable for release to patients. These activities include third-party analytical testing, expert consultant review, clinical risk assessments and engagement with regulatory authorities. Learn more