Western-BioTech - Pharma quality GH

[lightspan]

Dr. Jim and lightspan: These tests are way too technical for me to understand. So my question is this; are you guys stating that there are further tests that need to be done in order to prove the purity or what exactly are your complaints about his GH?

The issue is that Karl has made several claims which are questionable, and has been inconsistent in his statements. if you read the front end of this thread, you'll find there were claims to rigorous QA and mass spec analysis of the gh. Then Karl walked that back. That should give everyone pause. I don't like inconsistent statements about material Meso members will be injecting into their bodies.

In addition, to determine the actual identity of a protein (i.e., gh), ones does an amino acid sequence analysis. IIRC, gh comprises somewhere around 190 individual amino acids , which are linked together in a specific order. if the sequence of amino acids is incorrect, it can have essentially zero effect on the activity of the gh, or it can significantly affect the activity. you figure out the sequence via a digest, the details aren't all that important, just the take home: you can determine how the amino acids are hooked together, and if they are the correct residues in the correct order. if there are the correct number of resiidues hooked together in the correct order, then you have gh. if not, then you don't.

this matter because the recombinant e coli used to express gh can and do mutate over time, and if they do and start slowly diverging from producing gh to produccing something very close to gh, you have a problem. that is why pharma uses a half dozen different assay techniques, because there are minor variations that can have major effects, and one qualitative assay method can miss the change.

Pharma is doing sequence analysis on their proteins. They are assaying each lot. That's why shit gets expensive so quickly, they assay with SDS, sequencing, chromatography, in vivo assaying, etc. Karl is not doing MALDI-TOF MS to get MW, is not doing any sort of gel permeation chromatography (discussed by Dr. Jim above), and is claiming 99.5% purity based on SDS-PAGE. SDS-PAGE is a tool to quantify protein purity, but it does not give a "number," it is qualitative, and very slight MW differences are simply not shown in SDS-PAGE. the scale is in kiloDaltons, the travel lane is less than 6 inches. It's a spurious claim.

the upshot is this, Karl started by telling us that he is doing all of this QA, but the reality is that he is not, and those of us who have some experience with biotech are calling shenanigans. it does not mean his gh is not going to make you fucking superman, it means karl has made certain representations that are not supportable.

i'm not doing this because i'm bored, or because I have nothing better to do. i've got plenty of other shit to do, but I am a member of the Meso community, and as a member of the community i believe it is my responsibility, when I can, to ensure that Meso as a whole has all of the information possible, and that the information is accurate.

 

[Dr JIM]

Oh Dadgum K stop the nonsense!!

Look at the wells of MANDS GEP and look at the very small amount in yours.

Yea your claims of a 98% purity are based on SDS are nonsense.

THE FACT IS reviewing that which MANDS posted and "your data" is't clear the substances being tested are not only of a different purity but also of a different MW.

In other words they ARE NOT the same COMPOUND!

So while MANDS analysis seems to be most CW GH, I've NO IDEA what your tests analyzed.

Primarily because you have failed to present any evidence that supports your contention it was GH

Jim

 

[ufcguy32]

So can we agree that the product is gh or not lol. At this point it's getting so technical I'm getting confused.

 

[Western-Biotech]

I posted the tests we do on our lab, find my attachments back few weeks ago I'm not sure which inconsistency I showed later, it's funny actually.

The tests we do are the standard in this industry to confirm the potency and purity period. Now I wanna know now that Pfizer or Serano are making AA analysis in their production line, I wanna hear this now pls, this is interesting from the scientific point of view but may contribute nothing to the process of purification and validation. The most important test actually, and I repeat myself, in the biological assay tests which tests,
The USP defines certain protocol to asses the biological effect of GH. In a nutshell it tests the effect of GH which is injected by certain protocol to mice, which their hypophiza is removed, and check along 3-6 months their liner growth (and other parameters). This is quite complicated clinical trial.
In our facility we use more advanced biological assay tests - we check the prolifiration of human cells under exposure to the GH in the product. this is currently the ultimate test, as it test directly the interaction of the GH with target receptor and quantifies its direct clinical effect.
When mice are injected with GH there are more factors are involved in their growth, like nutrition, genetic parameters, enviorment influence etc', of course the test tries to isolate the effect of GH by giving similar nutrition etc' to the mice, but as you understand it can't eliminate 100% such conditions.
In the biological assay.
In this Specific test the Somastim was fond to be about 6% more active then Saizen, but he clearly says that the statistical difference is not significant - and as u may see the graphs are quite identical.

 

[Western-Biotech]

I just wanna confirm one detail with my professor with your permission, and this is based on what the purity is determined, pls bare with me till tomorrow, as I must be responsible on my claims as u demand, and I respect this

 

[lightspan]

So - I'm confused - you're all smarter then me - I wanna hear this - SDS-page is not used for assay of proteind purity ? not ?

My claims on purity of 98% are not valid ? Mands claims of purity of 99.5% are not valid ?

CLEARLY PLS, AND BACK UP YOUR CLAIMS

SDS-PAGE is used to quantify protein purity, i never said it wasn't. It is qualitative, and subject to certain limitations. It does not provide an infallible "number," as you have been representing. You claimed repeatedly it does. Please provide the details of how you are determining numerical purity of a 191 amino acid residue protein that has the sequence and identity of rHGH.

Mands provided analytical data which does prove purity of the peak in question off the hplc, IIRC. You didn't. Stop pointing to his MS results to justify your SDS claims. If mands had run SDS-PAGE and claimed 99.9% purity, I would be taking him to task over spurious purity claims. He did not, he had a detailed analysis done, i tip my hat to him on that score. Again, you did not.

I am happy to acknowledge that the material mands received contained high purity gh (edit for accuracy- had an hplc peak that, when analyzed via MS, was identified as high purity gh). What i have issue with is you misrepresenting and exaggerating your QA, which you have done repeatedly. You can produce high purity gh and have very little QA. It just means that you are prone to things going horribly awry. You admit that you use two qualitative assays, gel electrophoresis and a cell assay to QA your product. No ms, no residue sequencing, no GPC. There is a reason Genotropin costs an arm and a leg. Pfizer is doing all of those assays on every lot.

 

[bodybuilder_fl]

So can we agree that the product is gh or not lol. At this point it's getting so technical I'm getting confused.

Im in the same boat as ufc guy! got so technical that I'm confused too....as for now is the gh good to go or not?

 

[Western-Biotech]

LS - I claim clearly that our tests are beyond the necessary to confirm the proper purity and potency by any pharma standards, I'm careful with my full scientific claims, so will get an authorized explanation tomorrow.
If I were u I would be very careful with your claims, as you're certainly not an analytical chemist in this field, and have never been engaged in the manufacturing of such meds.
I know the tests which BTG (Bio Technology General) are doing to their GH product - Biotropin- and there are identical to ours as a fact, the only difference is the biological assay tests - they follow the FDA requirements while we follow the general scientific tests, which was actually proved to be superior

 

[Western-Biotech]

LS and the doc have confused the hell of everyone here.

Let me get it straight -
The sample Mands tested is 99.5% purity
We are commited to 98%+ purity which is the pharma standard

I ENCOURAGE EACH AND EVERY MEMBER FROM DAY ONE TO MAKE ANY ANONYMOUS ORDER, TEST US BY ANY STANDARDS AND CONFIRM MY STATEMENTS

 

[lightspan]

Im in the same boat as ufc guy! got so technical that I'm confused too....as for now is the gh good to go or not?

lol, sorry guys.

it's the same as any other gear. mands posted up tests showing what he received is g2g. YMMV. A source is only as good as the last pack he sent. Order it, get a serum test, and if it doesn't come up roses, scream bloody murder. Karl has claimed about 50 times he will address any issues that may come up.

 

[Dr JIM]

The issue is that Karl has made several claims which are questionable, and has been inconsistent in his statements. if you read the front end of this thread, you'll find there were claims to rigorous QA and mass spec analysis of the gh. Then Karl walked that back. That should give everyone pause. I don't like inconsistent statements about material Meso members will be injecting into their bodies.

In addition, to determine the actual identity of a protein (i.e., gh), ones does an amino acid sequence analysis. IIRC, gh comprises somewhere around 190 individual amino acids , which are linked together in a specific order. if the sequence of amino acids is incorrect, it can have essentially zero effect on the activity of the gh, or it can significantly affect the activity. you figure out the sequence via a digest, the details aren't all that important, just the take home: you can determine how the amino acids are hooked together, and if they are the correct residues in the correct order. if there are the correct number of resiidues hooked together in the correct order, then you have gh. if not, then you don't.

this matter because the recombinant e coli used to express gh can and do mutate over time, and if they do and start slowly diverging from producing gh to produccing something very close to gh, you have a problem. that is why pharma uses a half dozen different assay techniques, because there are minor variations that can have major effects, and one qualitative assay method can miss the change.

Pharma is doing sequence analysis on their proteins. They are assaying each lot. That's why shit gets expensive so quickly, they assay with SDS, sequencing, chromatography, in vivo assaying, etc. Karl is not doing MALDI-TOF MS to get MW, is not doing any sort of gel permeation chromatography (discussed by Dr. Jim above), and is claiming 99.5% purity based on SDS-PAGE. SDS-PAGE is a tool to quantify protein purity, but it does not give a "number," it is qualitative, and very slight MW differences are simply not shown in SDS-PAGE. the scale is in kiloDaltons, the travel lane is less than 6 inches. It's a spurious claim.

the upshot is this, Karl started by telling us that he is doing all of this QA, but the reality is that he is not, and those of us who have some experience with biotech are calling shenanigans. it does not mean his gh is not going to make you fucking superman, it means karl has made certain representations that are not supportable.

i'm not doing this because i'm bored, or because I have nothing better to do. i've got plenty of other shit to do, but I am a member of the Meso community, and as a member of the community i believe it is my responsibility, when I can, to ensure that Meso as a whole has all of the information possible, and that the information is accurate.

The issue is that Karl has made several claims which are questionable, and has been inconsistent in his statements. if you read the front end of this thread, you'll find there were claims to rigorous QA and mass spec analysis of the gh. Then Karl walked that back. That should give everyone pause. I don't like inconsistent statements about material Meso members will be injecting into their bodies.

In addition, to determine the actual identity of a protein (i.e., gh), ones does an amino acid sequence analysis. IIRC, gh comprises somewhere around 190 individual amino acids , which are linked together in a specific order. if the sequence of amino acids is incorrect, it can have essentially zero effect on the activity of the gh, or it can significantly affect the activity. you figure out the sequence via a digest, the details aren't all that important, just the take home: you can determine how the amino acids are hooked together, and if they are the correct residues in the correct order. if there are the correct number of resiidues hooked together in the correct order, then you have gh. if not, then you don't.

this matter because the recombinant e coli used to express gh can and do mutate over time, and if they do and start slowly diverging from producing gh to produccing something very close to gh, you have a problem. that is why pharma uses a half dozen different assay techniques, because there are minor variations that can have major effects, and one qualitative assay method can miss the change.

Pharma is doing sequence analysis on their proteins. They are assaying each lot. That's why shit gets expensive so quickly, they assay with SDS, sequencing, chromatography, in vivo assaying, etc. Karl is not doing MALDI-TOF MS to get MW, is not doing any sort of gel permeation chromatography (discussed by Dr. Jim above), and is claiming 99.5% purity based on SDS-PAGE. SDS-PAGE is a tool to quantify protein purity, but it does not give a "number," it is qualitative, and very slight MW differences are simply not shown in SDS-PAGE. the scale is in kiloDaltons, the travel lane is less than 6 inches. It's a spurious claim.

the upshot is this, Karl started by telling us that he is doing all of this QA, but the reality is that he is not, and those of us who have some experience with biotech are calling shenanigans. it does not mean his gh is not going to make you fucking superman, it means karl has made certain representations that are not supportable.

i'm not doing this because i'm bored, or because I have nothing better to do. i've got plenty of other shit to do, but I am a member of the Meso community, and as a member of the community i believe it is my responsibility, when I can, to ensure that Meso as a whole has all of the information possible, and that the information is accurate.

I just wanna confirm one detail with my professor with your permission, and this is based on what the purity is determined, pls bare with me till tomorrow, as I must be responsible on my claims as u demand, and I respect this

-----------------_____________

The GEP purity "estimate" is VISUAL only, as LS noted. There is no numerical value such as "98%" that is spit out by some computer, digital base, or mouse on a wheel.

So as that wheel moves up the run impurities are depleted until the MW resting point. Once that occurs an estimate of purity can be made which in the best of hands is + or - 10%!

But none of this really matters because the two compounds which were tested are (Karl's vs MANDS) NOT THE SAME, PERIOD!'

QA my ass!

Jim

 

[ufcguy32]

So how do u feel about gh serum and igf tests jim

 

[Western-Biotech]

Enlighten me and prove me these are not the same, full facts, specified now, and tell me what if it's the same ?

 

[ufcguy32]

Also mands did a random order from Karl so he had no idea he we getting test so my question is if mands test showed it to be pure isn't that the important part

 

[Dr JIM]

I posted the tests we do on our lab, find my attachments back few weeks ago I'm not sure which inconsistency I showed later, it's funny actually.

The tests we do are the standard in this industry to confirm the potency and purity period. Now I wanna know now that Pfizer or Serano are making AA analysis in their production line, I wanna hear this now pls, this is interesting from the scientific point of view but may contribute nothing to the process of purification and validation. The most important test actually, and I repeat myself, in the biological assay tests which tests,
The USP defines certain protocol to asses the biological effect of GH. In a nutshell it tests the effect of GH which is injected by certain protocol to mice, which their hypophiza is removed, and check along 3-6 months their liner growth (and other parameters). This is quite complicated clinical trial.
In our facility we use more advanced biological assay tests - we check the prolifiration of human cells under exposure to the GH in the product. this is currently the ultimate test, as it test directly the interaction of the GH with target receptor and quantifies its direct clinical effect.
When mice are injected with GH there are more factors are involved in their growth, like nutrition, genetic parameters, enviorment influence etc', of course the test tries to isolate the effect of GH by giving similar nutrition etc' to the mice, but as you understand it can't eliminate 100% such conditions.
In the biological assay.
In this Specific test the Somastim was fond to be about 6% more active then Saizen, but he clearly says that the statistical difference is not significant - and as u may see the graphs are quite identical.

Your groping K, using MICE as an comparative for the HUMAN testing of GH, BULLSHIT!

And I tell you this also WHO has set forth the guidelines for the patented production of approved GH and that also applies to the US. The FDA is also involved in certifying US GH sales and the proof of PURITY, and QUALITY are undeniable, but BOTH organizations mandate AA sequence analysis prior to lot sales.

As a QA company I thought you would know this unless your selling MOUSE rGH, lol!

 

[lightspan]

LS - I claim clearly that our tests are beyond the necessary to confirm the proper purity and potency by any pharma standards, I'm careful with my full scientific claims, so will get an authorized explanation tomorrow.
If I were u I would be very careful with your claims, as you're certainly not an analytical chemist in this field, and have never been engaged in the manufacturing of such meds.
I know the tests which BTG (Bio Technology General) are doing to their GH product - Biotropin- and there are identical to ours as a fact, the only difference is the biological assay tests - they follow the FDA requirements while we follow the general scientific tests, which was actually proved to be superior

You are correct, i do not manufacture and peddle gh. If i did, i would have my story straight. You've been called out repeatedly on inconsistencies in your story. That is the issue here. Frankly, i think you do have a pet professor, and you have video of him fucking a sheep, or he has a habit he needs to feed, so you were able to "persuade" him to make gh for you. Bully for you. I could give a fuck.

I've said the gh mands received is what you claim it to be. I even told a couple Meso members above to order your shit if they so desire and serum test. See, i'm not such a bad guy after all.

I am questioning your alleged QA and inconsistent statements. I will continue to question you. I'm sure Dr. Jim and others will as well, for the good of the community. Meso is a fucking cage match, and those who cannot survive go elsewhere.

 

[Western-Biotech]

As a comment - no one claimed that the tests I posted is the same batch as the one Mands tested, so tests may vary slightly, I just know by chance it's the same batch, so I know your claim is not valid

 

[Western-Biotech]

LS - which QA claim/claims of mine are inconsistent ?

No one ever said you're a bad guy, I enjoy from your comments, and admire your knowledge, I said clearly to you that I would be careful with my claims, which may be baseless, and I'll specify tomorrow, no disrespect, on the contrary

I suggest this - get your expert to talk over the phone with my professor and get an opinion, I offer here clearly to u like I offered to Mands - bring your expert to talk over the skype with my professor to acertain his professionalism and knowledge, more then this - he'll actually introduce himself by his name, and your expert will confirm he is an authority in his field, what we put on the line here? tell me now !

 

[Western-Biotech]

Your groping K, using MICE as an comparative for the HUMAN testing of GH, BULLSHIT!

And I tell you this also WHO has set forth the guidelines for the patented production of approved GH and that also applies to the US. The FDA is also involved in certifying US GH sales and the proof of PURITY, and QUALITY are undeniable, but BOTH organizations mandate AA sequence analysis prior to lot sales.

As a QA company I thought you would know this unless your selling MOUSE rGH, lol!

God help me - the USP regular biological assay test on HGH is done on mice, and again, you make here baseless claim after baseless claim, I respect this place, so I'll add no more

 

[Dr JIM]

Enlighten me and prove me these are not the same, full facts, specified now, and tell me what if it's the same ?

I've already done EXACTLY that K.

Read my last few posts or give them to your "professor" for an explanation, it matters not to me because this I also know, my knowledge didn't come from posting Wiki or by reviewing GH tests on forums.

Jim