Last week the Australian Therapeutic Goods Administration (TGA) quarantined 140 batches of human albumin after CSL found an equipment failure could have led to contamination with ethylene glycol. After taking the step the TGA allowed CSL to release batches that tests show to be safe for use.
“The TGA is allowing CSL to release batches of the product from quarantine where TGA is satisfied that testing of those batches has been undertaken to an appropriate standard, and that this testing demonstrates that the batch does not contain harmful levels of ethylene glycol”, the TGA wrote.
CSL traced the problem, which affects batches manufactured before January 25, to a hairline fracture in a tank used to produce albumin. The split allowed ethylene glycol, present in the casing to control temperatures, to leak into the tank.
After discovering the fracture CSL stopped using the tank and repaired the split. CSL has resumed production in the tank and says tests show no detectable levels of ethylene glycol. The Australia-based biopharma is also testing for ethylene glycol in 140 quarantined batches of Albumex.
Independent TGA testing is also planned as a quality assurance action. The TGA will run the tests in conjunction with an audit of manufacturing processes at the CSL Biotherapies production plant.
So far the TGA has assessed and released 28 batches, 11 on Friday and 17 on Monday. CSL is using tests that detect ethylene glycol at 0.5 parts per million (ppm). Last month the US Food and Drug Administration (FDA) published guidance recommending a concentration limit of 620ppm.
CSL also uses albumin at low concentrations as a stabilising agent in CSL Biostate (plasma derived Factor VIII concentrate). The low levels mean the “concentration of any contaminating ethylene glycol is likely to be negligible”, the TGA wrote, and as such Biostate batches stay on the market.
Last year the FDA sent CSL a warning letter after finding quality failings at its vaccine plant. The TGA also said it had audited CSL five times in the preceding year to investigate Fluvax adverse reactions, which a research paper linked to suboptimal virus splitting.