Manufacturing FDA hits BMS facility in Pheonix with warning letter...

FDA hits BMS facility in Pheonix with warning letter following contamination issues

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A Bristol Myers Squibb manufacturing facility has been issued a warning letter by the Food and Drug Administration (FDA) following contamination problems. The facility in question is one that produces the famous cancer drug Abraxane, which is an injectable form of paclitaxel that can treat cancers like that of the pancreas, lungs, and breast. It was first developed by VivoRx and initially acquired by Celgene later in 2019.

Celgene was acquired by Bristol Myers Squibb (BMS) for $74 billion and so the drug and plant at Pheonix came under BMS. The company also planned to add additional 150 personnel by the end of 2024.

Problems for the company started last April when a very large number of contaminated units were discovered. In the samples that were tested from the plant, up to 10 microbes, such as gram-negative and gram-positive microbes and spore-forming were identified as contaminants.

Media fill troubles with Abraxis rose again in July when even more contaminated units were brought to light and such problems continued well into October and November of the past year.

Therefore, after conducting an inspection in March-April 2022, FDA issued a warning letter to the head of BMS Giovanni Caforio. In the letter, the FDA spoke about the company’s failure to take preventative and corrective steps to ensure that its production and aseptic line was in order. 

The investigation revealed that the root cause of the problem was (b)(4) in the filing manifold which led to contamination in the equipment cleaning step. The letter was shared with the company on the 31st of October and its contents have been shared on the company’s website as well.

Excessive amounts of bioburden were found in the valves that allowed different types of bacteria to survive the sterilization cycle and consequently caused contamination in the media fill unit. The problem further escalated when last December, drug batches that were impacted by this negligence were released in the market.

While BMS has taken steps to rectify the situation such as rejecting suspect batches and suspending operations and filing a Field Alert Report, the agency still expects the drugmaker to provide a detailed response including a CAPA plan, an equipment evaluation as well as a third party evaluation and a report on quality assurance. 

According to the FDA, “The company’s investigation into the media fill flub was insufficient, Without a comprehensive assessment of contamination hazards and a [Corrective Action and Preventative Action (CAPA) plan] that builds more holistic risk mitigation into your operational design, there is no assurance that you can prevent recurrence of sterility problems due to various latent or active failure modes in your operation.”

The FDA has noted that the present situation is an indicator of how the aseptic filling line has failed to meet standards and current measures are not sufficient therefore they have also recommended the BMS subsidiary enlist the help of a current Good Manufacturing Practices (cGMP) consultant.

Abraxane sales just in the last year have brought BMS $1.18 billion in sales.

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