CSL safety review may affect human albumin supply
SUPPLIES of human albumin used in burns, trauma and surgical patients will be limited while its manufacture by CSL Ltd undergoes a safety review.
The TGA has temporarily quarantined all stocks of human albumin, after CSL informed the regulator on Wednesday that “some batches” of the product processed up to 25 January were contaminated.
The new contamination issue follows scrutiny of CSL’s vaccine manufacturing process in the wake of adverse events linked to its paediatric influenza vaccine in 2010.
Affected batches were found to contain “very low” levels of ethylene glycol, traced to a fault in the lining of a tank used in its manufacture.
Exposure to the chemical poses the risk of kidney damage or acute renal failure in patients.
“TGA has put arrangements in place to quarantine stocks held by hospitals, the Australian Red Cross Blood Service… and CSL from further use or issue until safety implications have been fully assessed,” the TGA said in a statement.
“As a result of this action by TGA, supplies of albumin may be limited in the immediate future.
“Clinicians should carefully consider the clinical need for albumin usage, as well as any alternative therapy that could be substituted, such as the use of alternative volume expanders.”
The TGA said there were no reports of adverse events linked to the contamination and CSL had advised they were unlikely given the low levels of the chemical detected.
“Over coming days, the TGA will be conducting further assessment of data provided by CSL, and will be conducting audits of CSL's manufacturing and quality assurance processes,” the regulator also said.
Dr Jeff Davies (PhD), executive vice-president of CSL Biotherapies, said the contamination was traced to a “hairline fracture” in a tank that had an ethylene glycol casing that controlled its temperature.
The fault had been fixed, and testing was underway to determine the exact number of batches affected.
“The company is working diligently with all relevant agencies to resolve this issue as quickly as possible and will keep the public informed of further developments,” Dr Davies said.
Australian Red Cross Blood Service spokeswoman Kathy Bowlen said there was no impact to the broader blood supply.
“Patients are still getting all the blood they need,” she told MO.
“There are 17 different products made from plasma and this is one of them.”
The affected albumin is also supplied to New Zealand, Hong Kong, Singapore, Malaysia, Taiwan, Indonesia and Sri Lanka and talks are underway with the relevant regulators.