Jazz Pharmaceuticals UK supplier hit with FDA warning
UK-based Porton Biopharma, supplier of Irish company Jazz Pharmaceuticals’ leukaemia treatment Erwinaze, has been slapped with an FDA warning letter citing concerns over production of the drug.
The FDA’s letter details “significant violations of current good manufacturing practice (CGMP)” for finished pharmaceuticals and active pharmaceuticals ingredients (APIs). The FDA previously performed an inspection of the Salisbury-based facility in January 2015 and found similar concerns; according to the warning letter, Porton proposed specific measures to correct these issues, though many were still apparent on the FDA’s March 2016 visit.
The FDA stated that the findings highlighted that “management oversight and control over the manufacture of drugs at your facility is inadequate, and that your previous corrective actions did not address persistent contamination hazards and drug quality issues”, though noted that Jazz Pharmaceuticals, as the Biologics Application Holder, must also share responsibility for the final product available to patients.
Among the concerns, the FDA noted that Porton “failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications”, noting specifically that a number of batches of Erwinaze were found to contain unacceptable levels of metal particles, an issue which Porton failed to address beyond updating its standard operating procedure.
The company also failed to “follow appropriate written procedures, designed to prevent microbiological contamination”, with the FDA identifying a number of violations related to its aseptic manufacturing operation. It noted that Porton had utilised a number of working cell banks before necessary review and approval, despite their “substantial potential to adversely affect the identity, strength, quality, purity or potency” of the drug.
Erwinaze (asparaginase Erwinia chrysanthemi) has secured US approval for the treatment of acute lymphoblastic leukaemia in those allergic to E.coli-derived chemotherapy drugs.
Porton has stated that it is prepared to work with Jazz Pharmaceuticals to tackle the issues, adding that it is “confident that we will fully address the FDA’s concerns” and will call in third-party inspectors to execute a full end-to-end review of its manufacturing processes. The company plans to expand its operational capacity for the drug, with long-term plans to improve quality control procedures.
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