TGA quarantines contaminated human albumin from CSL

Updated 2pm 09-03-12

The Therapeutic Goods Administration (TGA) yesterday announced a quarantine of human albumin solutions produced by CSL after the company discovered a fault in its manufacturing process that allowed some batches to become contaminated with ethylene glycol.

The TGA has informed hospitals and other medical organisations to cease use of this product until more tests can be performed to identify precisely which batches have been affected by the contamination.

This may lead to a shortage of albumin until replacement stocks can be made.

On 25 January CSL detected “very low levels” of ethylene glycol in batches of human albumin manufactured prior to that date. It immediately stopped production and investigated the cause of the contamination.

The cause was found to be a hairline fracture in a tank at its Broadmeadows plant used to manufacture the albumin. This fracture allowed ethylene glycol to enter the tank during processing. Ethylene glycol is contained in the casing around this tank and is used to control temperatures during the processing of albumin.

Once the tank was repaired, the newly produced albumin was tested and found to be uncontaminated by ethylene glycol. The next task was to determine which batches of albumin might have become contaminated by the leak.

According to a CSL spokesperson, stocks of albumin produced from November 2011 to 25 January 2012 were in storage and had not been distributed. The company then began testing to pinpoint the time when the leak occurred.

Doing so required the development of a special assay, with one being produced by CSL and one being produced by an external independent company. Once the assays were completed, CSL began testing its batches to determine which were contaminated.

It found on Monday 5 March that the product dating back to November 2011 did show signs of ethylene glycol contamination and contacted the TGA of the finding on 7 March, leading the TGA to instate the quarantine.

As the date of the leak has not yet been determined, CSL recommended quarantining all batches of albumin until the precise date is known. The company is now working back through stocks to pinpoint the date of the leak.

Once that date is known, uncontaminated batches will be released for use and contaminated batches may be recalled.

Ethylene glycol contamination can produce similar effects to ingesting alcohol, although without the corresponding expected blood alcohol level.

Other effects can include metabolic acidosis, which in serious cases can cause coma or death, and the formation of oxalic acid crystals, which can damage kidneys and other tissues and adsorb calcium ions, and can lead to acute renal failure.

The effects of ethylene glycol poisoning are acute, so any patient without symptoms 72 hours after administration is unlikely to be affected.

According to the TGA, based on projections of the highest possible amounts administered and available toxicological data, adverse clinical effects appear unlikely to occur.

CSL has not yet announced what the quarantine will cost the company.

CSL (ASX:CSL) shares closed at $32.50 on Wednesday 7 March, and dropped to a low of $32.30 on Thursday, and are trading at $32.63 as of 2 pm today.