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The SM-102 cationic lipid (and ALC-0315)
What's the difference between lab and commercial grades?
This is a very important question to ask for everyone who now knows that Moderna are using the SM-102 cationic lipid as part of their proprietary lipid nanoparticle (LNP) recipe for delivery of their also proprietary modified mRNA.
The reason I say this is a very important question to ask is because I am not sure anybody knows whether or not the cationic lipids used in the LNP formulations by Moderna and Pfizer are lab, or commercial grades. If somebody does know, can you let me know? The [Cayman] Safety Data Sheet (SDS) for the SM-102 cationic lipid refers to a product “not for human or veterinary diagnostic or therapeutic use”, so I assume that this particular version of SM-102 is lab grade. But assuming makes an ‘ass’ out of ‘u’ and ‘me’. We really need to know if the manufacturers have actually adhered to Good Manufacturing Practices (GMPs) and are, in fact, using the United States Pharmacopeia (USP) grade version and not the lab grade version. (I will explain, don’t worry.) Because, if they aren’t, this would be cataclysmically bad.
The slide that seems to be making the rounds from my Sweden talk above refers to the Cayman SDS (for product suspended in ethanol) where it is written that the product is for research use, so this is why I assume that this SM-102 version is lab grade. What is lab grade?
On lab grade
Please refer to Science Company’s website for a list of the different quality grades from highest (1) to lowest (7).
A chemical grade of relatively high quality with exact levels of impurities unknown; usually pure enough for educational applications. Not pure enough to be offered for food, drug, or medicinal use of any kind.
So in other words, not for human use. Agreed? So I think it’s safe to say that the SDS refers to a lab grade SM-102 product. It could also be ACS or Reagent grade but both of those wouldn’t be for human use either.
Cayman Chemical have their very own LNP kit called Cayman Chemical LIPID NANOPARTICLE (LNP-MC3) KIT. You can buy the kit and make your very own lab grade LNPs. You can perfect the recipe yourself for eventual use in specific contexts - without the need for all that expensive microfluidic mixing equipment! Once you’ve gotten your mixture and conditions just right, you can move onto commercial grade products for use of your LNP in humans and impress assholes at dinner parties with stories of how you’ve made billions as a proprietor of some fatty note. Sorry, I can’t seem to help myself with these snarky, sarcastic yet clever quips.
Here’s the SDS sheet for the version of SM-102 suspended in ethanol (not chloroform).
Alrighty then. Everything looks copacetic.
Let’s take una pausa. I went on a web search for what people think the difference between a lab and commercial grade product is. I like seeing what real people think. Read the following paragraph that I found in response to a question posted online about lab grade versus commercial grade products.
Background: I'm a chemist and have worked for companies in Pharma, Research Chemical Supply, and Dietary Supplements.
Lab Grade is different than Food Grade, yes. Normally Food Grade is a LOWER quality than Lab Grade.
Lab Grade normally has exhaustive testing on it to determine all impurities. The lab is using this as a reagent and they need to know all that.
Food grade means that it won't cause human disease. So really all they need to know is if there are too many heavy metals or too many bacterial contaminants. The limits are typically higher for food grade.
For instance, when I worked at a Pharmaceutical facility we worked to get a material accepted by FDA as a food grade material and not a Pharma Grade or Reagent Grade. The main reasons were insect and metal parts. The FDA regulations are much more relaxed for food grade and you can have quite a few more of each in the product for food grade than either of the other two.
The FDA regulations are much more relaxed for food grade, eh? Hmm.
Now, read this. This is a disclaimer written by Echelon Biosciences to clear up the unholy mess that me and some other nosy kids have created by learning that certain (lab grade) cationic lipids have a bad score with regard to human health. Worse than gasoline!
So these biotech guys are claiming the opposite of the chemistry guy. They claim that the lab grade stuff undergoes less strict manufacturing and testing processes than the stuff being administered to people. So which is it? Who’s right? Generally, one would seek out ACS1 or Reagent grade2 for lab work since when you’re mixing chemicals, you kind of want to mix the things that you want to mix, and not other stuff.
The companies who manufacture [the cationic lipids] and other components for the vaccine are following Good Manufacturing Practices (GMP) standards (as required by the FDA) and their facilities are inspected to ensure that their manufacturing processes are controlled and safe for human use.
Ok. Why don’t I feel re-assured here? Are the FDA doing their job and checking in on our little LNP production fairies to make sure that they are using commercial-grade products? The trusty pharmaceutical companies would NEVER rush safety trials or use lab grade products, would they? They would always use USP or National Formulary (NF) grade products. Right?
Well let me ask you something. Do you trust the FDA after what they’ve done over the past 3 years? I don’t.
On commercial grade
Again, please refer to Science Company’s website for a list of the different quality grades from highest (1) to lowest (7).
A chemical grade of sufficient purity to meet or exceed requirements of the United States Pharmacopeia (USP); acceptable for food, drug, or medicinal use; may be used for most laboratory purposes.
A grade of sufficient purity to meet or exceed requirements of the United States National Formulary. (Since bought out and merged with the United States Pharmacopeia, USP-NF.) THM: it’s the same as USP.
Ok, so like we talked about, the SM-102 and the ALC-0315 cationic lipids used to make the LNPs by Moderna and Pfizer, respectively, must meet either one of these standards in order for them to be appropriate for use in humans, right? Let’s visit the USP website. You can sign in and download their Analytical Procedures for mRNA Vaccine Quality Draft Guidelines. I did. You can find that here. Teehee, I just learned that I can drag and drop pfds! Thanks Jikky.
I was so excited to finally learn where the ‘safe and effective’ mantra came from and to finally be proven wrong about my worries concerning lacking GMPs and upscaling abilities!
Quote from Analytical Procedures for mRNA Vaccine Quality Draft Guidelines:
Since the successful application of mRNA technology is relatively new, regulatory guidelines and industry standards to guide non-proprietary aspects of mRNA quality during development and manufacturing are still evolving. These include areas such as verifying the identity of the drug substance, controlling impurities and measuring content for dosing. Without a common set of methods for determining quality, developers and manufacturers of mRNA products must develop their own in-house methods and protocols, taking attention and resources away from a company’s successful application of mRNA technology unique to the medical product.
What was that someone said once? Something about learning to build the plane mid-flight or something?
I read the whole thing and there’s a lot of stuff about how to make and quality control the mRNA. But the fact that they admit that ‘non-proprietary aspects of mRNA quality during development and manufacturing are still evolving’ disturbs me and I also have to wonder about the propriety aspects since, well, they’re private. The public should be able to have access to details on what they’re being injected with, shouldn’t they? From both ‘companies’, right? They’re also looking for helpful input, by the way. If you happen to have any. Upscaling issues are not sufficiently addressed either.
But we want to know about the LNPs and cationic lipids. Wait now, there’s no section on LNPs. How can that be? I want to see the same rigorous pdf write-up for LNPs. I tried the keywords ‘cationic’, ‘lipid nanoparticle’, ‘SM-102’ and ‘ALC-0315’ in the search bar, and the USP website turned up nothing. The only return I got was for the keyword ‘lipid’ and it’s bizarre. Why do they describe the lipids potentially used for RNA delivery as “fancy” and what does ‘mostly avoided’ mean?
Is this not how one seeks information of USP standards associated with a product? It worked for Vitamin C and Ivermectin (that they refer to in BLOCK LETTERS as a dangerous good) and Remdesivir and cholesterol. Maybe it’s because the LNPs don’t comprise the ‘product’ because they are part of ‘packaging’? But then how does one quality-control-check the packaging? All chemicals can and should be graded so like I said, the cationic lipids used in the COVID shots MUST have a USP grade, right? Or some grade, other than a lab grade, right?
Where are the commercial grades for the cationic lipids documented? This is one of those times when it’s getting late and I feel like my own sleuthing skills have been maxed out. Maybe one of my crafty readers can find it.
I actually really, really want to find this.
I going to leave this hanging for now. I have no answer to my original question as to whether or not Moderna and Pfizer are using USP grade cationic lipids, etc, in their LNP formulations. So beyond assuming that they are making these cationic lipids themselves using the most astonishingly pristine GMPs to product grade-USP products, I have to assume that they might not be. I might even assume that they are using lab grade products.
Someone please prove me wrong.
Oh, by the way, the only one of the 7 grades listed with the actual word ‘commercial’ in it the description is the last one called Technical grade.
Good quality chemical grade used for commercial and industrial purposes. Not pure enough to be offered for food, drug, or medicinal use of any kind.
I wonder if they might be using this grade. It’s both a commercial and an industrial operation to produce billions of doses of products after all, isn’t it? The only thing is, it’s not for use in humans.
Maybe go back to The Price is Right horn to end this Substack with an uncomfortable laugh.
A chemical grade of highest purity and meets or exceeds purity standards set by American Chemical Society (ACS). https://www.sciencecompany.com/Learn-Chemical-Grade-Definitions-from-Highest-to-Lowest-Purity..aspx
High purity generally equal to A.C.S. grade and suitable for use in many laboratory and analytical applications. https://www.sciencecompany.com/Learn-Chemical-Grade-Definitions-from-Highest-to-Lowest-Purity..aspx