Wednesday, April 7, 2021

Continued bad news at Emergent

Via the New York Times, this news on Emergent BioSolutions, the vaccine CMO that both Johnson and Johnson and AstraZeneca were using: 

But four former company officials, speaking on the condition of anonymity because they had signed nondisclosure agreements or feared retaliation, described an environment where top Emergent leadership tolerated and even encouraged the flouting of federal standards for manufacturing and marketing products.

One of the former officials said that as the company scrambled to meet the heavy demands of vaccine production, a senior manufacturing supervisor often responded to reports of quality errors by asking: “Do you want me to make drugs or fix issues? I don’t have time to do both.”

That's a pretty appalling statement, if true. Here's more details about the cross-contamination problem: 

The Johnson & Johnson and AstraZeneca vaccines use the same technology: A harmless version of a virus — known as a viral vector — is transmitted into cells to make a protein that stimulates the immune system to produce antibodies.

Sometime in February, Emergent workers had unknowingly contaminated Johnson & Johnson’s viral vector with AstraZeneca’s. The error was not discovered for weeks, until, in one of the final checks before release, Johnson & Johnson sampled a batch of 13 million to 15 million doses’ worth of vaccine for purity.

In short order, top Biden administration health officials directed a hold on shipments from the Baltimore facility and instructed Johnson & Johnson executives to take charge of its operations. Days later, they quietly told AstraZeneca officials their vaccine would no longer be made at the Baltimore plant, to avoid a repeat of that error. 

That is extremely bad news, and the fact that they still don't understand why it happened (i.e. "unknowingly") tends to indicate to me that Emergent doesn't have control over its processes, which doesn't provide me much confidence in their products. It's a good thing Johnson and Johnson isn't relying on Emergent to provide doses for the ongoing vaccination campaign. (It's also really bad news for AZ that their manufacturing efforts are suffering another blow too.) 

Manufacturing problems aren't new. I feel like we have been extremely fortunate that we have been able to manufacture two vaccines that haven't seemed to suffer quality problems (that we know of yet...), and that there are manufacturing issues with one of the CMOs for one of the vaccines is a sign that we're not immune to the law of averages. 

1 comment:

  1. I once had an operator charge isopropyl alcohol to a reactor instead of isopropyl acetate. Drums of both solvents were in the processing suite because we used each at different points in the process. Clearly, the operator had looked at the first part of the name only instead of the full name and material code numbers. Thankfully the operator caught the error before getting much further along in the process and we were able to work through the error, but honestly, it would have likely torched the batch if the error wasn't pointed out. This Emergent situation seems like it could be similar, depending on how materials are labelled.


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