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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

#81

Post by manuelmoreale »

damau wrote: post #80
Johnny555 wrote: post #62

Earlier quoted context omitted.

Apparently it started in the 18th century, so there's a lot of inertia to overcome to get people to change. But she says it was from the 18th century onwards that people started using male pronouns when describing someone of a non-specific gender in writing and this marks the time when opinions on what pronouns should be used started to change. "You might have a sentence like 'if a student comes to see the teacher, h…

I have been learning Italian. Don’t slam me for this if it’s wrong I am a beginner. But there are a number of contexts in Italian to which lei (she) is used. One for polite and respectful use (such as a general in the army, regardless of gender) or if the person’s gender is unknown. Just thought I’d throw that out there.

Very formal/polite way to refer to people yes. But in Italian we also have “voi” and its use can be traced back centuries before “lei” started to be used.

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

#82

Post by Kim_Bruning »

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.

Sounds like what epistasis is describing is a healthy QA environment with rapid feedback.

Some other comments have already pointed out that 15M doses is probably only one or a few batches. Combined with the fact that the procedure documents for this particular line are probably still warm from the laser printer, I'd say let them iterate a bit more to get the kinks out.

[ Procedures are not (should not be) engraved on stone tablets handed down from on high. If you try it that way, you are just as guaranteed to fail as when you had no procedures at all. ]

As to what went wrong at this facility (besides overpromising?); we'll have to see. I wish there was such a thing as open source procedures!

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

#83

Post by manquer »

maxerickson wrote: post #16
briefcomment wrote: post #3

How do you make 15 million of anything without realizing there's an issue, let alone the most scrutinized thing on the planet right now?

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 out of service

Just because there are high capacity machines capable of doing that much does not mean it should be used especially a With a new process trying to scale up

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

#84

Post by rcxdude »

Guthur wrote: post #51
duckfang wrote: post #49

"He"?

Yes, a common and accepted genderless pronoun.

It has been commonly used and accepted in the case of unknown or unspecified gender, though it is rapidly falling out of favour for that case. In part because I think it's quite hard to say that it's truly 'genderless', it's embedding a 'default' into the language which perhaps is undesirable.

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

#85

Post by BLanen »

DarknessFalls wrote: post #19
anitil wrote: post #15

It bothers me that people have expectations of perfection. Of course there will be breaks in the chain the lead to doses being wasted. There are thousands or millions of ways for it to go wrong, and only a few ways for it to go right. It is an astounding miracle of human progress that we can get to this point.

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.

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

#86

Post by markus92 »

hn8788 wrote: post #18
bitcharmer wrote: post #14

Earlier quoted context omitted.

Honest question: if the facility wasn't approved by the FDA then why was it manufacturing the vaccines at all? And how could such vaccines be used anywhere if they were produced by an unapproved facility?

Maybe the approval process includes a "must have met X criteria for the past Y months", so once you get approved, everything you've done in the past Y months counts as having been created in an approved facility. I'm just guessing though, I have no idea what the process is.

Basically this. You need four consecutive batches with consistent quality in a row for approval.

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

#87

Post by tomaskafka »

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…

You might have smaller batches and smaller throughput, but some pesky people keep shouting that we need all the vaccines yesterday :).

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

#88

Post by maxerickson »

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…

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.

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

#89

Post by eyelidlessness »

optimalsolver wrote: post #52
eyelidlessness wrote: post #32

Earlier quoted context omitted.

Well now I just feel old.

The Wire came out almost 20 years ago.

Yes, and I watched it about 15 years ago and didn’t remember enough to recognize the reference.

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

#90

Post by epistasis »

fermienrico wrote: post #50
epistasis wrote: post #42

Earlier quoted context omitted.

I'm not in Germany, but I also get very frustrated when the Pfizer name is applied to what BioNTech created. BioNTech is going to be doing amazing things later on too, with their great tech platform. I have a feeling that news sources are very guarded about introducing new names to the public, especially ones as difficult to pronounce as BioNTech (I've heard some great butchering of the pronunciation too).

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 brand recognition drives dollars, and in biotech the ability to raise money is just as much a hurdle as the chances of your trial failing.

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