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Baltimore plant ruins 15M Johnson and Johnson coronavirus vaccines

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Re: Baltimore plant ruins 15M Johnson and Johnson coronavirus vaccines

#91

Post by kodah »

BLanen wrote: post #85
DarknessFalls wrote: post #19

Earlier quoted context omitted.

I was ready for the knee-jerk response to pounce and heap damnation on the plant for messing it up. But you have a very valid and insightful point.

I was ready for the knee-jerk hackernews response where people complain about deserved criticism. I don't know how you people expect things to get better if this wouldn't happen.

There's a big difference between complaining and curiosity. Really, there's a whole host of ways to think and vocalize improving a system without complaining.

Re: Baltimore plant ruins 15M Johnson and Johnson coronavirus vaccines

#92

Post by epistasis »

markdown wrote: post #75
epistasis wrote: post #41

Earlier quoted context omitted.

Errors like this happen in every single GMP and clinical facility. What makes them different is 1) there are ample checks in place to prevent mistakes from ever leaving the facility, and 2) there is process that reduces the chances of having it happen in the first place. But all of these places will have incident logs of mistakes like this, along with corrective actions that change the procedures and make it less lik…

> Errors like this happen in every single GMP and clinical facility. They shouldn't happen in a 150yr old, multi-billion dollar pharmaceutical company. How hard is it to restrict the ingredients available to the "chef" to the ones needed for the current product? Not hard at all unless you want to save a few dollars cutting corners.

Being GMP isn't about eliminating all errors everywhere, it's about acknowledging the inevitability of error, minimizing error through conscious processes that stop those errors, and testing to assure that you made what you made.

In a situation where maximizing vaccine production sooner saves lives, pinning this on saving a few dollars doesn't make sense. Whatever they were doing cost them quite a few dollars in addition to the lives lost from slower vaccination.

I don't know their process, but suppose the "restricting the ingredients" phase happens. What if the ingredients were swapped at the time of restriction? Same problem happens.

Re: Baltimore plant ruins 15M Johnson and Johnson coronavirus vaccines

#93

Post by Throwawayaerlei »

DoingIsLearning wrote: post #73

Alternate title: Quality Control and Safety procedures (put in place to meet medical manufacturing regulations) prevent a bad batch of vaccines from entering the market and potentially harming patients.

Or the people who went to add ingredients to a AZ/Oxford batch found they were missing.

Re: Baltimore plant ruins 15M Johnson and Johnson coronavirus vaccines

#94

Post by Throwawayaerlei »

hn8788 wrote: post #2

I wonder if those vaccines were primarily going to be distributed locally. I live nearby, and my county's weekly covid update said they expect to have most people 16+ vaccinated by the end of April because we're supposed start getting an increased number of vaccine doses every week.

If by locally you mean anywhere near the factory, no, for it just makes raw vaccine, which gets shipped to specialist firms that do "fill and finish."

A paper, pretty sure it was The Washington Post ran a hit piece on the company and how Baltimore was behind on getting vaccines or something, and they replied pointing out they're just doing this under contract, they have no say in the disposition of doses. Which of course is several levels above them.

Re: Baltimore plant ruins 15M Johnson and Johnson coronavirus vaccines

#95

Post by Throwawayaerlei »

This is a bigger thing than anyone here realizes, for Emergent BioSolutions is a notorious company who's core competency is politics, not production, see one or more recent New York Times articles on them. This is a minor fowl-up compared to the sorts of things many of us have been expecting from this factory of their's.

Re: Baltimore plant ruins 15M Johnson and Johnson coronavirus vaccines

#96

Post by manquer »

maxerickson wrote: post #88
manquer wrote: post #83

Earlier quoted context omitted.

The question should be more why would there have to be such large batches which can be SPOF for so many doses. Wouldn't it make more sense to make smaller seperate batches to derisk the process. This is akin to me using a large 64 core server for an app, instead of say 4x16 . Sure, the larger server can easily handle the load, however the 4x16 setup is more redundant and avoids many scenarios where all users will be…

The production goal is hundreds of millions of doses this year, so I guess I wouldn't want to speculate too much about what batch size is sensible.

eventual goal maybe, Not for the month of March. 15M out of planned 20M ? . The scale out for any process starts small to try avoid this kind of issues.

Yes fuck ups happen at plant and in planning, and yes we are not experts in the field to comment in detail on what is best approach. However if you are looking at it as an admin, clearly risk was not well managed.

Re: Baltimore plant ruins 15M Johnson and Johnson coronavirus vaccines

#97

Post by fermienrico »

epistasis wrote: post #90
fermienrico wrote: post #50

Earlier quoted context omitted.

May be its just easier to pronounce Pfizer than BioNTech? Not everything needs to be distilled down to nationalistic undertones. I am getting sick of this kind of discussion permeating on HN - It is extremely juvenile and damaging to the spirit of HN. In this regard, Reddit seems to be a lot better. Go on any vaccine related thread and there is absolutely none of this. There is so much more global cooperation observe…

This has nothing to do with nationalism. I'm not German. I don't care about whether Germany gets credit for this. I care about BioNTech getting credit. My complaint, beyond just the media, is that large pharma, like Pfizer, being fundamentally uninnovative companies that grow by acquisition rather than invention. And about small companies being denied the potential to grow because of an oligopoly of control. Name bra…

I see your point, and that's a valid concern. I wonder how much damage public PR does to investors - who are supposed to be highly informed and not be pursued by public hype.

Re: Baltimore plant ruins 15M Johnson and Johnson coronavirus vaccines

#98

Post by markdown »

epistasis wrote: post #92
markdown wrote: post #75

Earlier quoted context omitted.

> Errors like this happen in every single GMP and clinical facility. They shouldn't happen in a 150yr old, multi-billion dollar pharmaceutical company. How hard is it to restrict the ingredients available to the "chef" to the ones needed for the current product? Not hard at all unless you want to save a few dollars cutting corners.

Being GMP isn't about eliminating all errors everywhere, it's about acknowledging the inevitability of error, minimizing error through conscious processes that stop those errors, and testing to assure that you made what you made. In a situation where maximizing vaccine production sooner saves lives, pinning this on saving a few dollars doesn't make sense. Whatever they were doing cost them quite a few dollars in addi…

> What if the ingredients were swapped at the time of restriction? Same problem happens.

Chef goes to find eggs as required by the recipe for his cake, and finds that there are none. Instead there is pepper, an ingredient not required by the recipe.

Re: Baltimore plant ruins 15M Johnson and Johnson coronavirus vaccines

#100

Post by fragmede »

manquer wrote: post #83
maxerickson wrote: post #16

Earlier quoted context omitted.

Dose is 0.5 ml. Say the batch is equivalent in volume to the final doses (who knows, but it should be somewhere vaguely close). That's 7,500 liters. Microbrewers often use fermenters larger than that.

The question should be more why would there have to be such large batches which can be SPOF for so many doses. Wouldn't it make more sense to make smaller seperate batches to derisk the process. This is akin to me using a large 64 core server for an app, instead of say 4x16 . Sure, the larger server can easily handle the load, however the 4x16 setup is more redundant and avoids many scenarios where all users will be…

To use the same alarmism and a software analogy: sw developer destroys thousands of hours of CPU time with bad code!1 Yet every single time I push, the CI pipeline runs an extensive suite of automated tests, and I'd not have it any other way. Wait but CPUs aren't being destroyed by running tests, you say. Yeah but niche reporting is always atrocious and a mainstream writer can't be trusted to get things entirely right.

(If you're using a 4x16 server, whatever that is, to provide isolation in your system, you may want to talk to additional devops folks for other options.)

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