"Generic" GH ASSAYS

[janoshik]

Keep the commentary HERE I've no problem with it.

Hey Jano I noted a few of the HPLCS you conducted and cited on PM and you're asking me for more data, what a farce.

Im willing to bet his "testing" went something like this
Jano is given a Grey sample fully labeled to include the IU content

Jano then can adjust the HPLC device to match whatever quantitative value he is provided.

There is NO BLINDING involved, PM is happy and Jano is delighted as both will receive "fair compensation" sooner or later for work "well done".

Contrast this with what MANDS and I are doing in a fully BLINDED MANNER.

A holding mailbox receives unlabeled samples, that are then forwarde directed to the lab.

Until recently I never knew the manufacture or the sample concentration (yep some simply refuse to comply and sent a fully labeled Godtropin and Somastatin to the holding BOX, and both were trashed!)

The involved facility conducts the assays and forwards the results to me as a FULLY BLINDED certified lab, rather than a Jano one man lab band!

There simply is no comparison and why PM or ANY UGL is willing to accept such gross deviations from existing lab standards is beyond reason.

Hmmm but maybe it has something to do with the amount of MONEY involved!

You've already been corrected regarding this, Mr. JIM.

Regarding the money - I can't really afford doing things for free as anybody has to make a living. I like to help people, but I like to get paid for that as well as I have to make a living and pay off the lab.

Also some of the tests I performed (like the immunoassay in the testing on PM.com) were conducted by 3rd party - a fully blinded certified lab, not with 50, but with thousands of employees and I had to pay off those as well. I think you would see this as a plus.

However, for the same reason you are not disclosing the exact lab you work with I couldn't disclose the lab that the immunoassays were conducted at to anybody but Mr. Racepicks, Mr. Buck and Mr. Muscle96ss, whom all I hold in great regard.

Really, and thru what mechanism did Jano receive these samples?

Did he know he would be testing GH?

What was the standard he used for comparison?

Where is his concentration calibration curve?

Where on these HPLC does he correlate % with concentration in mg?

Where is the MW listed as compared to the standard?

Was a Mass Spec conducted to confirm the HPLCS MW estimate was accurate?

Did Jano ever confirm his HPLC assays were accurate and run an AAA on any of these samples?

ALL OF THIS INFO is standard for ANY protein based HPLC as it ensures reproducibility and reliability from one sample to the next?

To that end if you only knew the amount of information that was NOT included in Janos HPLCS you wouldn't even consider asking me for more "raw data".

Ya better finish cleaning the testing problem in your own back yard before ya try mine bc what we have posted is as good as it gets, excepting that which is required for published research.

Why don't you take a gander at my second attempt to post GH data using
HPLC and note ALL the criticism I received in spite of divulging much more than what this lab rat posted.

The bias was unequivocal and intentional.

Bottom line Jano gives them what they
WANT and I give them the evidence based TRUTH.

The FACT IS UGL GH remains a crap shoot, some a better crap shoot than others, and if your lucky maybe you will avoid STARCH being the cause of a sticky plunger.

Mr. JIM, thank you. Thank you for ceasing the straight out hostility and starting what I believe to be a proper discussion.

Those are proper questions (although some of the questions are quite off) and I shall not be further taken into an account until I answer them, which should be right after I finish in my job.

To be fair @muscle96ss although @jano came over asking legit questions about the process he was quick to toss some stones JIM's way. This has to do with history between them both already I'm guessing and that's only speculation.

I would like all to participate and be clairvoyant if all possible in this process.

Night all! Have to hit the gym and eat one more time before I get some Zzzzz's

@muscle96ss I'lol chat with you tomorrow.

mands

I agree and apologise. I have a short fuse.

Ok GREAT I'll assume Jano was blinded to the samples origin or concentration @Buck1973
and as for my other queries any idea why such info is ENTIRELY ABSENT?

I ask bc such info of this nature is the analytical lab standard and one I willingly complied with when my HPLCs were cited on my second generic GH thread.

It's seems there's a double standard here JANO gets by posting the bare minimum but Dr Jim is held to the LEGITIMATE LAB standard.

Hmm I think the operational word is called BIAS! Or maybe I'm wrong it's all about those Benjamin's.

See up.

Its to bad you two cant bury the hatchet and cooperate with each other. The meso community would benefit in a huge way if that were to happen. Oh well!!!? Who cares rt? As long as you come out the winner of the argument , fuck what coulda been.
And to you guys tossing insults at jano, that dont know the first thing about gh, ( never used and never studied it)PLEASE STOP!!!! Your making yourself look foolish. Not naming names but if the shoe fits..........
I think Dr JIM and a few others are qualified to debate him the rest just look like dick riders.

I already told to Mr. Mands that I will support this project.

What you have yet clarified is WHO sent these samples to Jano.

Bc it's my understanding all of our samples are being donated by consumers themselves not that UGL would have reason to spike a sample, right.

I believe they were collected from the members the same way you collected your samples. If you dig around the board I'm sure you can confirm that.

I have no interest in cooperating with someone that produced fake data for an ugl. Nor am I interested in cooperating with a so called lab tech with a such a limited understanding of biochemistry that he wasn't even aware that a biological assay is still needed to confirm that you actually have rhGH - and had to be corrected by Karl, of all people.



I wish you would have named names, B66. That way I would know whether I should be pissed off at you or not.

I have never produced a fake data for an ugl nor anybody else.

I don't care about a single UGL enough to destroy my reputation, when there are dozens of UGLs using my services.

If I even faked data it would be, sooner or later, found out and do you think the rest of the UGLs using me for quality control would keep on using me? Or that the users who get their gear tested by me would trust me?

Also, the most, 90% of the samples sent to me are the samples which I have no idea where they come from and you can ask people around that I do not care.


Karl only talked about US pharmacopoeia and didn't really feel like he was contradicting me, as he doesn't care about the EU one at all. He was just pointing out that the bioassay is in the US one and I said that I am not aware of it being in EU one.

You somehow keep omitting that I found out about my mistake myself, without being called out by anybody and nobody noticed (and probably wouldn't notice) my mistake.

Yet I posted about it publicly and apologised.

Can you say that you can recite the European Pharmacopoeia word by word? Because I certainly can't and had never stated so. I missed one line in the book.

Bc Meso and PM don't "play" by the same rules, and reasons should be obvious fella!

Like I mentioned, I am not bound to any board.

These are Jano's HPLCs as cited on PM, perhaps he can answer my questions rather than post another deflection, detour, or will simply deny such info is the contemporary lab standard.

The reason such information is CRITICAL; bc what one is left with in it's absence is A LOT of "raw data" without a means of correlating numerical or percentile values into something useful, a specific MANUFACTURERS SAMPLE, or it's concentration in mg.

Im sorry guys but I honestly don't know what the intent was, but the results are ANYTHING but transparent or readable from an evidence based perspective.

See above. Only fair of you requesting this from me.

 

[janoshik]

But I also feel like you are deflecting from my questions regarding your own contradictions and knowledge regarding the subject.

 

[Buck1973]

What you have yet clarified is WHO sent these samples to Jano.

Bc it's my understanding all of our samples are being donated by consumers themselves not that UGL would have reason to spike a sample, right.

To clarify how the process worked when we did the recent tests @ PM.
all samples were collected by consumers most before we announced we were collecting, NO samples were asked for or accepted from any sponsor or anyone affiliated to one. they were sent to Mr. RP he delabeled and relabeled them,then they went to Mr. Jano...

Just My Thought on my xpectations as a tester or someone posting results;
xpect to be questioned You may take heat have yr facts ready. be prepared to state yr case. if I miss something be ready and willin to correct it. We test to learn (Knowledge, facts is wat is of importance).
I m Not suggesting anything to you or anyone eles.
But bringin forth results I would do my best to answer anyones inquiries.
By the same token If anyone has questions on Mr. Jano's testing or performance I am sure he would answer and wellcome them in the appropriate place, his thread or anywhere he posts results.
I look forward to any type of testing here or anywhere. and as Mr Muscle stated I always open.
Sorry if I am O/T Thanks to Mr. Mands and Yrself for sharing yr Time, xpences, and Testin with the public....

Peace

 

[rpbb]

To clarify how the process worked when we did the recent tests @ PM.
all samples were collected by consumers most before we announced we were collecting, NO samples were asked for or accepted from any sponsor or anyone affiliated to one. they were sent to Mr. RP he delabeled and relabeled them,then they went to Mr. Jano...

Just My Thought on my xpectations as a tester or someone posting results;
xpect to be questioned You may take heat have yr facts ready. be prepared to state yr case. if I miss something be ready and willin to correct it. We test to learn (Knowledge, facts is wat is of importance).
I m Not suggesting anything to you or anyone eles.
But bringin forth results I would do my best to answer anyones inquiries.
By the same token If anyone has questions on Mr. Jano's testing or performance I am sure he would answer and wellcome them in the appropriate place, his thread or anywhere he posts results.
I look forward to any type of testing here or anywhere. and as Mr Muscle stated I always open.
Sorry if I am O/T Thanks to Mr. Mands and Yrself for sharing yr Time, xpences, and Testin with the public....

Peace

Good post Buck, professional and to the point. Always appreciate that in a scientific debate

 

[rpbb]

But I also feel like you are deflecting from my questions regarding your own contradictions and knowledge regarding the subject.

That's where time and patience always pays off. It all works out in the end if you do that

 

[Geterdun]

Its to bad you two cant bury the hatchet and cooperate with each other. The meso community would benefit in a huge way if that were to happen. Oh well!!!? Who cares rt? As long as you come out the winner of the argument , fuck what coulda been.
And to you guys tossing insults at jano, that dont know the first thing about gh, ( never used and never studied it)PLEASE STOP!!!! Your making yourself look foolish. Not naming names but if the shoe fits..........
I think Dr JIM and a few others are qualified to debate him the rest just look like dick riders.

The shoe fits me perfectly buddy, but I can't learn from @jano when he comes in throwing rocks like he did. Not knowing him, or his credentials, I can only assume he has alterior motives when he is paid to do the same thing that's being done here for free. Most of his posts are in the same manner from the little I read. If Dr J is being aggressive, what would you call the shoe on @jano ?

@Mr.B66 I have no issues with you at all and really try to learn in this thread. You have to be fair and send these same comments to the one who stormed in to this thread and started this mess. JMO

 

[janoshik]

That's where time and patience always pays off. It all works out in the end if you do that

I completely agree with you.

The shoe fits me perfectly buddy, but I can't learn from @jano when he comes in throwing rocks like he did. Not knowing him, or his credentials, I can only assume he has alterior motives when he is paid to do the same thing that's being done here for free. Most of his posts are in the same manner from the little I read. If Dr J is being aggressive, what would you call the shoe on @jano ?

@Mr.B66 I have no issues with you at all and really try to learn in this thread. You have to be fair and send these same comments to the one who stormed in to this thread and started this mess. JMO

I apologise for appearing to be rude, I have a short fuse.

Like I already explained, I make a living out of testing a it also has it's costs for me. I can either do testing and get paid for it, or cease testing at all and do something else for living.

 

[Geterdun]

I completely agree with you.



I apologise for appearing to be rude, I have a short fuse.

Like I already explained, I make a living out of testing a it also has it's costs for me. I can either do testing and get paid for it, or cease testing at all and do something else for living.

Thank you for the apology, and I guess we will just agree to disagree on paying. Members pay good money for GH, Generic, or Pharma, but offer willing. Dr J and Mands both find a way to do this free of charge as well. Testing isn't free for anyone, but to this point, unless it goes to Simec and even than, the provider usually covers the cost of the testing taking place, you seem to be the only one taking money. I could be wrong, I'm no expert, but haven't read of anyone else. Again, thanks for the apology and GL.

 

[tp2013]

Hi. I am here one more and most probably last time to do what i had promised. I will be scanning the assays and posting here soon but in the mean time this info. is coming from GREYTOPS factory. .this is directly from the horses mouth.

1) Based on the Test Items for HGH in "Chinese Pharmacopeia (CP)" "US Pharmacopeia (USP)" and "European Pharmacopeia (EP)", you can find that these Pharmacopeias all have adopted multiple-test methods to ensure the quality of GH, but they all do not use Liquid chromatography–mass spectrometry (LC/MS) as the routine QC test for GH. Nowadays, the test items for GH in different Pharmacopeias include: Purity Test by HPLC, Related Proteins Test, High Molecule Protein Test, Isoelectric Point Test, Peptide Mapping Test, Periodical N-Terminal Sequencing, DNA Sequencing of Expression Plasmid, and Relative Biological Activity Test etc. If the primary structure of GH has changed or the 3D structure has changed, that will lead to all the changes in Retention Time, Isoelectric Point, Peptide Mapping as well as Relative Biological Activity. Therefore, the above test methods can work together to ensure the primary structure and spacial structure (3D structure) of GH are correct.

2) The Purity Test by HPLC is to compare the Chromatographic Peak Area of the Sample to be tested with the Chromatographic Peak Area of the GH Working Standard (The Working Standard is provided by the Biological Product Institute of China FDA, for which the Assay of GH is known and given), and then External Standard Method is used to calculate the Assay of GH.

3) Now I am attaching the N-Terminal Sequencing Result of our GH here for your reference. This test result is exactly identical with the N-Terminal Sequence of the 191 AA Recombinant GH in "Chinese Pharmacopeia".( This was given to me but i do not think it is needed here. I will just post the HPLC testing we did on blacks later on)

 

[janoshik]

As far as I am aware I am the only commercial provider of such services, except SIMEC.

Thank you, it's much easier to talk, when the talk is free of strong emotions.

I have messaged Mr. Mands regarding subject, that might help to shred a bit of light upon the comparation of our testing processes.

 

[rpbb]

Hi. I am here one more and most probably last time to do what i had promised. I will be scanning the assays and posting here soon but in the mean time this info. is coming from GREYTOPS factory. .this is directly from the horses mouth.

1) Based on the Test Items for HGH in "Chinese Pharmacopeia (CP)" "US Pharmacopeia (USP)" and "European Pharmacopeia (EP)", you can find that these Pharmacopeias all have adopted multiple-test methods to ensure the quality of GH, but they all do not use Liquid chromatography–mass spectrometry (LC/MS) as the routine QC test for GH. Nowadays, the test items for GH in different Pharmacopeias include: Purity Test by HPLC, Related Proteins Test, High Molecule Protein Test, Isoelectric Point Test, Peptide Mapping Test, Periodical N-Terminal Sequencing, DNA Sequencing of Expression Plasmid, and Relative Biological Activity Test etc. If the primary structure of GH has changed or the 3D structure has changed, that will lead to all the changes in Retention Time, Isoelectric Point, Peptide Mapping as well as Relative Biological Activity. Therefore, the above test methods can work together to ensure the primary structure and spacial structure (3D structure) of GH are correct.

2) The Purity Test by HPLC is to compare the Chromatographic Peak Area of the Sample to be tested with the Chromatographic Peak Area of the GH Working Standard (The Working Standard is provided by the Biological Product Institute of China FDA, for which the Assay of GH is known and given), and then External Standard Method is used to calculate the Assay of GH.

3) Now I am attaching the N-Terminal Sequencing Result of our GH here for your reference. This test result is exactly identical with the N-Terminal Sequence of the 191 AA Recombinant GH in "Chinese Pharmacopeia".( This was given to me but i do not think it is needed here. I will just post the HPLC testing we did on blacks later on)

thanks tp, looking forward to seeing the data

 

[Dr JIM]

These are Jano's HPLCs as cited on PM, perhaps he can answer my questions rather than post another deflection, detour, or will simply deny such info is the contemporary lab standard.

The reason such information is CRITICAL; bc what one is left with in it's absence is A LOT of "raw data" without a means of correlating numerical or percentile values into something useful, a specific MANUFACTURERS SAMPLE, or it's concentration in mg.

Im sorry guys but I honestly don't know what the intent was, but the results are ANYTHING but transparent or readable from an evidence based perspective.

Yep another deflection on behalf of Jano. You guys at PM were ripped of bc he did not "perform" squat!

 

[Dr JIM]

thanks tp, looking forward to seeing the data

It should be obvious by now Jano won't post HIS DATA, that's why I had to, and once again he deflects and detours but refuses to cooperate from an evidence based perspective.

Oh and @jano what the heck is "MeCN"
I ask bc it and H2O are listed as the solvents used in all FIVR of your HPLCS?

 

[DickySmalls]

Hi. I am here one more and most probably last time to do what i had promised. I will be scanning the assays and posting here soon but in the mean time this info. is coming from GREYTOPS factory. .this is directly from the horses mouth.

1) Based on the Test Items for HGH in "Chinese Pharmacopeia (CP)" "US Pharmacopeia (USP)" and "European Pharmacopeia (EP)", you can find that these Pharmacopeias all have adopted multiple-test methods to ensure the quality of GH, but they all do not use Liquid chromatography–mass spectrometry (LC/MS) as the routine QC test for GH. Nowadays, the test items for GH in different Pharmacopeias include: Purity Test by HPLC, Related Proteins Test, High Molecule Protein Test, Isoelectric Point Test, Peptide Mapping Test, Periodical N-Terminal Sequencing, DNA Sequencing of Expression Plasmid, and Relative Biological Activity Test etc. If the primary structure of GH has changed or the 3D structure has changed, that will lead to all the changes in Retention Time, Isoelectric Point, Peptide Mapping as well as Relative Biological Activity. Therefore, the above test methods can work together to ensure the primary structure and spacial structure (3D structure) of GH are correct.

2) The Purity Test by HPLC is to compare the Chromatographic Peak Area of the Sample to be tested with the Chromatographic Peak Area of the GH Working Standard (The Working Standard is provided by the Biological Product Institute of China FDA, for which the Assay of GH is known and given), and then External Standard Method is used to calculate the Assay of GH.

3) Now I am attaching the N-Terminal Sequencing Result of our GH here for your reference. This test result is exactly identical with the N-Terminal Sequence of the 191 AA Recombinant GH in "Chinese Pharmacopeia".( This was given to me but i do not think it is needed here. I will just post the HPLC testing we did on blacks later on)

Can someone explain this to me like I'm retarded? Thanks

 

[Dr JIM]

As far as I am aware I am the only commercial provider of such services, except SIMEC.

.

Commercial provider of WHAT service?

 

[RandallNowan]

It's not that easy for a retard to understand, Dude...
A machine looks at the size, weight and shape of things and uses those to analyse the sample. (oversimplification to the point of bullshit, but that's about the way it works, retard!)

 

[Dr JIM]

TP the problem is it seems your comparing the standards for generics (and there are NONE) to that of Pharmaceutical GH.

1) The WHO established guidelines for GH Q/A many years ago and although some countries are "allowed" to deviate based on need such alterations forbid the importation of their products into the U.S.

2) GH "purity" involves sequencing and the relative proportions of specific AA within a GH molecule ....... This is something HPLC can not do in the traditional sense UNLEES such testing is preceded by Amino Acid Hydrolysis.

The HPLCS Jano and I posted in the past evaluates the ENTIRE GH molecule while an AAA fragments all those AA critters
and sort of compiles a list of each.

The point "purity" testing can NOT be performed by HPLC as its described in that quote!

3) the terminal N portion of a GH
molecule has certain characteristics that enable IT to be used for serum based ELISA assays

Hope that helps.

Jim

 

[Dr JIM]

It's not that easy for a retard to understand, Dude...
A machine looks at the size, weight and shape of things and uses those to analyse the sample. (oversimplification to the point of bullshit, but that's about the way it works, retard!)

Are such comments necessary, NIMO!

 

[RandallNowan]

Are such comments necessary, NIMO!

I was responding to DickySmalls' request for it to be explained to him like he was a moron, Doc.
With a degree of humour, I hoped.

 

[Dr JIM]

BC here are MANY who are not aware of the specifics of GH testing from a more practical perspective, efforts should be made to enable their understanding whenever possible and that should include resellers such as TP IMO.

That being said its obvious I mistook Dicky Smalls self deprecated humor for that of TPs and believed you were being critical of TP himself. My error!