Tuesday, October 30, 2012

CGMP.CO (without the M)

Anyone that engage(s) in the manufacture, preparation, propagation, compounding, or processing of a drug or drugs shall register and submit a list of every drug in commercial distribution [to the FDA]

The above statement is the text of 21 CFR section 207 and appears to be the way the FDA gets a list of all drug facilities they need to inspect.  Incidentally, the FDA provides a way to search that here.

Search for Lonza Biologics:

fda lonza search result

and you get this:

fda lonza search result


Now check this out.  Here's the same query over at cGMP.co:


Click into the Hopkinton, MA result and you see wayyyyy more information:

fda lonza search result

Quite frankly, you can cross-reference the address with Google Maps to get a picture of where this place is.

You can cross-reference this facility with the list of FDA inspections that happened there.  Perhaps a list of 483s or warning letters that was issued there.

You can see all the other facilities that are owned by Lonza as well as the other cGMP companies located in Hopkinton.

So what's this have to do with Zymergi?

Well, for one, this was built with our software: Zymergi SQL Tool.  We eat what we bake.

For two, I'm interested in finding more leads that I can turn into customers.

For three, I'm interested in owning web-properties that can help connect cell culture/fermentation/cGMP folks.

Let me know how I can improve it.

disclosure: cGMP.co is owned and operated by Zymergi LLC.

Monday, October 15, 2012

Congrats, #RedBull #RedBullStratos and @BaumgartnFelix!

My bladder is having a hard time with my eyes just LOOKING at this picture:

Congratulations to RedBull and Felix Baumgartner for an amazing, remarkable, historic... (insert your "wow" adjective here) jump!

Here's the Yahoo article on the space jump.

Wednesday, October 10, 2012

Cell Culture Engineers are #Keynesians

It occurred to me today that the cell culture/fermentation engineers are to genetically engineered cells what Keynesian economists are to the modern economy.

This is not to say that cell culture/fermentation engineers are charlatans... but if you were a CHO cell, you'd certainly suspect that cell culture engineers don't exactly have your best interests in mind.

You see, the purpose of large-scale cell culture is not, in fact, to sustain a viable biological system.

We know this because at the end of every production culture, the cells are sent down the drain and suicided in the waste kill system. After outliving their usefulness, the cells are... in fact... waste.

The fact of cell culture is that we are replicating a biological system in a stainless steel tank - a phony environment... stimulating the culture with nutrient-rich media so that the cells can engage in the phony economy of secreting the active pharmaceutical ingredient.

We start with eugenics in the seed cultures. This is where we maintain a high copy count of the genes that produce the active pharmaceutical ingredient. Should an offspring be unable to produce enough API, it will die off from being in selective media. The genetic composition of the cell population is thereby controlled.

We then start a series of stimulate/bailout where we transfer the culture into successively larger volumes. When they've consumed their finite resources and polluted their environment, we bail them out into a larger volume.

The ultimate endgame happens at the production scale where we grow the cells beyond the carrying capacity of the culture - crashing their economy and population - so that we can harvest the fruits of their labor.

As cells don't have feelings or livelihoods, I don't feel so badly as a fermentation engineer. These cells were engineered by us for exactly one reason and the end result tends to be life-saving molecules to treat and cure human disease.

But were I a modern economist advising a stimulate/bailout path-forward so the politicians can get re-elected, I'd be a bit more responsible.

The catastrophic collapse of a population and its economy is as predictable as it is scientifically repeatable.  

Tuesday, October 9, 2012

Free #FDA 483s Offer Is Over. But @FDAzilla Has Opened A 483 Store

Bad News.  The Free 483s Dropbox Folder Offer has ended.

Earlier this year, I found out that FDA483s.com was offering all of the FDA.gov's free 483s in an organized format in a Dropbox:

My biggest problem using these files was:

  • Click through 7 separate pages to see what was free
  • When you downloaded the file, it was some gibberish like ucm191924.pdf
So when FDAzilla went through and curated it all and put it in a Dropbox, I was really happy to get access.

Afterall, commercial cell culture that produces API in the US is regulated by the FDA and that means you are subject to FDA inspection... most of which my customers are.

Good News.  FDAzilla has opened a 483 store where you can purchase 483s cheaply, instantaneously and anonymously.

Tony tells me that qualifying purchase will grant you access to the Dropbox.

Monday, October 8, 2012

Pristine Bioproduction

There's a company out there called, Pristine Bioproduction.

pristine bioproduction disposable cmo
And it's run by a Genentech alum named, Tim Matthews.  He's an early-stage contract manufacturing organization and their edge is single-use bioreactors.

Here's the deal.  The global mAb market is valued at 15.6 billion and is projected to double in the next 5-years to almost 32-billion by 2017.  Between now and then a lot of folks are going to be entering the market with products, and a lot of the manufacturing capacity is tied up with big biotech.

The reason you outsource your manufacturing is so you can focus on your core competency: R&D and process development.  You let the big guns handle your manufacturing and commercialization strategy.

Guys like Tim have been down that road.  In fact, the cool part about Pristine is that they offer agility with single-use technologies, which translates to greater speed and lower costs.

Questions Tim gets all the time are:
  • How can I be certain my CMC strategy is going to fly?
  • How do I best ensure that my manufacturing/supply-chain partner is the best fit?
  • How can I be be assured that disposable technologies will work for me?
Those other people's questions