a few more GENERIC GH ASSAYS

[ProfessorX]

For what it's worth, Im confident in telling you VERY FEW University based research facilities require the assistance of a commercial lab for a variety of reasons, most important of which is OUTLANDISH FUNDING from a variety of sources.

I'm not sure I follow.....but: (They are a private lab)

Provider of contract research, specializing in biological mass spectrometry and informatics, since 2008. We offer a broad range of proteomic services designed for specific applications. We combine specialized sample handling and sample preparation tools and methods with state-of-the-art instrumentation, cloud-based computational resources and fit-for-purpose data analytic pipelines to yield the best quality data, consistently.

Our clients include over 400 institutions on four continents, including government researchers at institutions such as DOD, FDA (CBER, NCTA), NIH (NIH CC, NEI, NINDS, NIDDK, NCI CCR, NIEHS, NIDCR, NIAID, NHLBI, NIAAA) USDA, USGS and VA, academic researchers at institutions such as Baylor College of Medicine, Harvard Medical School, Johns Hopkins University, Stanford University and Yale Univeristy School of Medicine, research institutes such as J. David Gladstone Institutes, Mayo Clinic, Samuel Roberts Noble Foundation and Woods Hole Oceanographic Institution, as well as private companies in the agriculture, biotechnology, energy, food, healthcare and pharmaceutical industries.


Hopefully the results are comparable.....as you stated before.....the cost (AAA) isn't so bad and normally the turn-around for results is fairly quick

 

[Buck1973]

Well based on the assay we conducted and repeated thats an accurate quantitative result, which means 2.08 mg is what is IN THE VIAL!

(Nonetheless for further confirmation this Sero "B" sample will be run AGAIN at
one of the largest University research labs in the country!)

So assuming the result is correct and, I've no reason to beleive otherwise, WHY a "Pharma" sample would contain only 50% of what is listed on the label is the more important question at this juncture IMO.

And that's what I'm looking into at present, BUT the reason is almost always THE SAMPLE SOURCE, IME.

Dr. Jim,
I only seen 1 lab results on a sero posted.
I also seen that Mr. Mands is contactin EMD Serono. this tells me there is no doubt about the origin or authenticity of this Product.
So I have to ask;
Its been said many times here that Pharmas are the way to go and are far superior, even at half dose? Have these guys been screwin these believers the whole time???
A FDA regulated Injectable I cant imagine how stringent these guidelines are to sell in Pharmacies are.
They let these underdosed Products out in circulation and you happened across it????
now I have a very limited understandin of how all this works, drug production and manufacturing and sales in the U.S.
But A 55.00 dollar AAA test uncovered a drug company sellin a underdosed Product under the watch of the FDA.


So with these words below, that are on the AAA report posted of the Sero,
Do we take the quantitative, mgs of HGH in the bottle as accurate????
There seems to b a xplination of why some things may b out of range. would this have a effect on the Mgs. Content?
"Tyr and MET might have gotten damaged in the hydrolysis depending on what else was in there" could the "what eles" be the missin 1.92 MGS. of HGH?
I hope you can understand the scepticism

https://thinksteroids.com/community/attachments/smple-b-pdf.54313/

 

[Cpriest88]

Don't be so discouraged. There are many good things coming out of this testing and further testing will be posted and provided on suspect samples. Including TP's black tops and GOdtropins along with Seros.

mands

It's more frustration then anything honestly ...

To the layman (like myself) it appears quantitative testing of this polypeptide seems rather elusive to even the self proclaimed best techs that have taken on this uncommon task (testing UGL or retail sourced rhgh) . As every group is skeptical of the others results and accuracy.

I wonder what analytics/methods are used for controls by Big Pharma under guidance by FDA or International guidelines... whether it's in-process or batch testing ... and if it's the same as the methods utilized here ...

I read in these threads that AAA is the gold standard ... meaning pharmaceutical companies subscribe to the same testing for QC?

 

[Cpriest88]

Why when I pop my head into Mands & Dr Jims threads there are always 2 or 3 "active members" complaining? They all seem to say the same thing and question the legitimacy of these tests! Not to mention you take one look at these cunts posting history here and 98% of their posts are in these threads! Gtfoh

Ironically the 98% of your posts that I've seen on this board is questioning the legitimacy of users and the true agenda behind their posts.... do you use meth or amphetamine like substances ? Your detector is always set on paranoid ... and you rush into discussions like a tweaked out maniac. Might want to switch up meds, or consider marijuana or benzos to level you out man.

I can't imagine you on 100mg Tren Ace ED. Ever ran it?

 

[CdnGuy]

Ironically the 98% of your posts that I've seen on this board is questioning the legitimacy of users and the true agenda behind their posts.... do you use meth or amphetamine like substances ? Your detector is always set on paranoid ... and you rush into discussions like a tweaked out maniac. Might want to switch up meds, or consider marijuana or benzos to level you out man.

I can't imagine you on 100mg Tren Ace ED. Ever ran it?

Just wait til I hop on the gear again my friend looool Tren? child's play...

 

[janoshik]

It's more frustration then anything honestly ...

To the layman (like myself) it appears quantitative testing of this polypeptide seems rather elusive to even the self proclaimed best techs that have taken on this uncommon task (testing UGL or retail sourced rhgh) . As every group is skeptical of the others results and accuracy.

I wonder what analytics/methods are used for controls by Big Pharma under guidance by FDA or International guidelines... whether it's in-process or batch testing ... and if it's the same as the methods utilized here ...

I read in these threads that AAA is the gold standard ... meaning pharmaceutical companies subscribe to the same testing for QC?

AAA is not a gold standard for pharmaceutical analysis, I've called bullshit on JIM too many times on that already... What they use for routine testing is HPLC methods.

Just wait til I hop on the gear again my friend looool Tren? child's play...

Yeah we get it, you are a big guy.

 

[CdnGuy]

AAA is not a gold standard for pharmaceutical analysis, I've called bullshit on JIM too many times on that already... What they use for routine testing is HPLC methods.



Yeah we get it, you are a big guy.

Big guy? Far from Jano and as they say "size ain't shit". Was just a smart ass comment back at a smart ass

 

[Cpriest88]

Hop on gear ? So what are you on?

 

[CdnGuy]

Hop on gear ? So what are you on?

On? Medical leave lol Waiting for surgery...

 

[ProfessorX]

cpriest88

Jano

(I thought this was informative)

The European Pharmacopoeia (Ph. Eur.) defines requirements for the qualitative and quantitative composition of medicines,

Characterisation and Impurities

Characterisation of drug substance has been performed by analytical evaluation of representative drug substance lots and compared to reference standards (Ph. Eur. BRP, NIBSC). The studies were performed using an appropriate panel of orthogonal analytical methods and comprise analysis of the primary structure, modifications in the primary sequence (disulfide bonds, deamidation, oxidation, acid isoforms) as well as studies on the presence of high and low molecular weight forms. In addition, the secondary structure as well as the biological activity has been investigated. Characterisation studies were performed using appropriate state of the art methods such as MS, tryptic peptide mapping and LC/MS analysis, IEF, SEC, RP-HPLC, DEAE-HPLC, HI-HPLC and CD

Specification

For the drug substance a specification has been provided which comprises testing of appearance and pH, identity by CE, HPLC (RP, SEC), peptide map and N-terminal sequencing, content assay by SEC, purity by determination of high molecular mass proteins (SEC), related substances including met-rhGH (RP-HPLC), charged variants (CE), host cell proteins and DNA as well as sterility and endotoxin content. This specification is in compliance with the EP monograph.

Product specification

In addition, tests are included for appearance and suspension time, particle size distribution of the suspended powder, in vitro release of rhGH from the suspension, content uniformity, HA content and lecithin content. To better control batch consistency and drug product quality the acceptance ranges for protein related proteins determined by SEC and RP-HPLC and for the assay were revised during the procedure.

The impurity profile of rhGH in LB03002 drug product was studied by applying different orthogonal analytical methods. It can be concluded that a higher amount of dimers, oxidised and deamidated variants is present in LB03002 when compared with reference material. Aggregates were not detectable in a higher amount.

Batch results were provided for all batches produced so far. Approximately 100 commercial batches of different fill weights of LB03002 drug product have been produced at the commercial plant. Whilst predominantly 12 mg rhGH/vial was manufactured batch results are also available for 2 mg rhGH/vial, 9 mg rhGH/vial, 4 mg rhGH/vial and 24 mg rhGH/vial. The results of all test parameters fulfilled the acceptance criteria.

 

[Cpriest88]

@ProfessorX damn I tried googling for literature like this ... thanks! Hah. A characterization "study" ! I wonder how much that would cost.

 

[CdnGuy]

Hop on gear ? So what are you on?

Btw Cpriest88 since you have taken my earlier post personal. It wasn't directed at the guy's who are actually contributing. You and ProfessX are great assets in this field. Thank you..

 

[mands]

It's more frustration then anything honestly ...

To the layman (like myself) it appears quantitative testing of this polypeptide seems rather elusive to even the self proclaimed best techs that have taken on this uncommon task (testing UGL or retail sourced rhgh) . As every group is skeptical of the others results and accuracy.

I wonder what analytics/methods are used for controls by Big Pharma under guidance by FDA or International guidelines... whether it's in-process or batch testing ... and if it's the same as the methods utilized here ...

I read in these threads that AAA is the gold standard ... meaning pharmaceutical companies subscribe to the same testing for QC?

Believe me I've been frustrated for years after trying and trying to give back to the community. Jim and myself have worked hard, along with his uncle who recently passed(one smart mother f'er) on testing GH and trying to find a facility that is top of the line.

You think you have found one and in come naysayers or as you say the skeptics. I'm not knocking anyone for questioning the testing methods at all. It's good to be skeptical and question. But, at what point to you just finally realize that you have to take the information given and make your own educated decision?

There is a way to question IMO that is constructive. Some just call bullshit without anything to back it up. No studies, no articles, no references, etc. I believe 95% of us are here to work together to make fellow members and members of the community safer and to keep sources doing the right thing. Obvious the other 5%(No Rich Piana pun intended) you can tell pretty quickly.

I'm just hoping the majority will see what we are trying to accomplish and support it.

I support our current lab completely and trust in the work they are doing. What other lab will bend over backwards and double, triple check and even send to another lab if you question the results. Most would say... That's it that's all you get.

mands

 

[janoshik]

Big guy? Far from Jano and as they say "size ain't shit". Was just a smart ass comment back at a smart ass

And that was just a metaphor

cpriest88

Jano

(I thought this was informative)

The European Pharmacopoeia (Ph. Eur.) defines requirements for the qualitative and quantitative composition of medicines,

Characterisation and Impurities

Characterisation of drug substance has been performed by analytical evaluation of representative drug substance lots and compared to reference standards (Ph. Eur. BRP, NIBSC). The studies were performed using an appropriate panel of orthogonal analytical methods and comprise analysis of the primary structure, modifications in the primary sequence (disulfide bonds, deamidation, oxidation, acid isoforms) as well as studies on the presence of high and low molecular weight forms. In addition, the secondary structure as well as the biological activity has been investigated. Characterisation studies were performed using appropriate state of the art methods such as MS, tryptic peptide mapping and LC/MS analysis, IEF, SEC, RP-HPLC, DEAE-HPLC, HI-HPLC and CD

Specification

For the drug substance a specification has been provided which comprises testing of appearance and pH, identity by CE, HPLC (RP, SEC), peptide map and N-terminal sequencing, content assay by SEC, purity by determination of high molecular mass proteins (SEC), related substances including met-rhGH (RP-HPLC), charged variants (CE), host cell proteins and DNA as well as sterility and endotoxin content. This specification is in compliance with the EP monograph.

Product specification

In addition, tests are included for appearance and suspension time, particle size distribution of the suspended powder, in vitro release of rhGH from the suspension, content uniformity, HA content and lecithin content. To better control batch consistency and drug product quality the acceptance ranges for protein related proteins determined by SEC and RP-HPLC and for the assay were revised during the procedure.

The impurity profile of rhGH in LB03002 drug product was studied by applying different orthogonal analytical methods. It can be concluded that a higher amount of dimers, oxidised and deamidated variants is present in LB03002 when compared with reference material. Aggregates were not detectable in a higher amount.

Batch results were provided for all batches produced so far. Approximately 100 commercial batches of different fill weights of LB03002 drug product have been produced at the commercial plant. Whilst predominantly 12 mg rhGH/vial was manufactured batch results are also available for 2 mg rhGH/vial, 9 mg rhGH/vial, 4 mg rhGH/vial and 24 mg rhGH/vial. The results of all test parameters fulfilled the acceptance criteria.

Thanks!

I think the HI-HPLC might be obsolete at this point and that's just an artifact in there, but all the other methods I have researched. I don't know much about this except it's similar to RP.

CD (circular dichroism) is good tool, but very impractical.

IEF provides very little useful information.

If I am understanding correctly, the SEC and RP-HPLC is used for regular analyses, which is what I had been talking about being the most sensible way to test HGH. Also what I had advised people over at Professional Muscle to use. Correct, Mr. @Buck1973 ?

A pity LCMS is not more available, but this confirms what I had been saying again and again - ID, purity and related substances can by done by SEC and RP HPLC alone and those come off to me as the most useful tools that there are in the repertoire.

@ProfessorX damn I tried googling for literature like this ... thanks! Hah. A characterization "study" ! I wonder how much that would cost.

A lot.

It's always a compromise between the price and amount of data you can get, we've had endless discussions about this with Mr. Buck and Mr. Muscle96ss.

What I'm doing is what I believe to have the best ratio of price and value.

I don't think AAA is by far as good, but if I ever see and hear BACKED UP DATA suggesting otherwise, I'll be happy to chance my opinion.

Believe me I've been frustrated for years after trying and trying to give back to the community. Jim and myself have worked hard, along with his uncle who recently passed(one smart mother f'er) on testing GH and trying to find a facility that is top of the line.

You think you have found one and in come naysayers or as you say the skeptics. I'm not knocking anyone for questioning the testing methods at all. It's good to be skeptical and question. But, at what point to you just finally realize that you have to take the information given and make your own educated decision?

There is a way to question IMO that is constructive. Some just call bullshit without anything to back it up. No studies, no articles, no references, etc. I believe 95% of us are here to work together to make fellow members and members of the community safer and to keep sources doing the right thing. Obvious the other 5%(No Rich Piana pun intended) you can tell pretty quickly.

I'm just hoping the majority will see what we are trying to accomplish and support it.

I support our current lab completely and trust in the work they are doing. What other lab will bend over backwards and double, triple check and even send to another lab if you question the results. Most would say... That's it that's all you get.

mands

I had no reason to doubt the accuracy of the results of your assays, my attention was only caught by JIMs contradictions, misinformation posted and direct attacks at my work when I first came here.

I started being concerned when more of the results started coming back different from the results I had acquired - though I am very aware of possibility of inter and intra batch inconsistency. The Sero case is waiting to get cracked, if I'm to say so.

I might talk with Mr. @ProfessorX about testing one of the same kit to check it out.

Anyway, with all this talk I gotta say I do appreciate your work and the nerves you've put into this.

You come off as an honest man and nothing you've done or said suggests otherwise.
If you ever ask me for an opinion, explanation or help, I won't say not without a good enough reason.

 

[PrideofNYC123]

Since when is Serostim Manufactured by EMD a Canadian rHGH manufacturer, been approved for sale in China, the latter being a clear cut violation of existing WHO proprietary rHGH sales guidelines.

The origin of these "discrepancies" is the sample SOURCE and ALWAYS is, IME!

Seros are ONLY approved for sale in the U.S. and Canada and perhaps a few other small countries who do NOT have the resources to manufacture rHGH.

Use the "lot number" and contact EMD
bc these are NOT legit PHARMACEUTICAL Seros !

The Serostim is real. EMD Serono allows anyone to check the validity of the products using the Check My Meds app. I scanned the picture of the box included.

 

[ProfessorX]

THANK YOU noswttea4u !!

(I didn't think the Pharmacy was handing out fake Seros)

MESO can be a very tough crowd

So yes, I agree JANO, MANDS has always conducted himself on a higher plane, always level headed

FYI: Seros, Omnitrope, or any other samples are available for you anytime JANO. Just ask

Here's the FULL ARTICLE: (Ph. Eur. EuropeanPharmacopoeia)

I think you, Jim, Mands, and Cpriest88 will appreciate it:

- Finished medicinal product

- Pharmacology

- Pharmacokinetics


http://www.ema.europa.eu/docs/en_GB...ssessment_report/human/002196/WC500148755.pdf

 

[Cpriest88]

http://www.ema.europa.eu/docs/en_GB...ssessment_report/human/002196/WC500148755.pdf

Great reading material! thanks!

 

[Sdryx]

The Serostim is real. EMD Serono allows anyone to check the validity of the products using the Check My Meds app. I scanned the picture of the box included.

Do these verifications self destruct? Meaning that once verified, any further verifications of the same code will indicate that it has already been checked?

Or would it be possible to counterfeit the box/labels with a copied and pasted verified code that can be used over and over and still flag as legit?

 

[ronin17]

Believe me I've been frustrated for years after trying and trying to give back to the community. Jim and myself have worked hard, along with his uncle who recently passed(one smart mother f'er) on testing GH and trying to find a facility that is top of the line.

You think you have found one and in come naysayers or as you say the skeptics. I'm not knocking anyone for questioning the testing methods at all. It's good to be skeptical and question. But, at what point to you just finally realize that you have to take the information given and make your own educated decision?

There is a way to question IMO that is constructive. Some just call bullshit without anything to back it up. No studies, no articles, no references, etc. I believe 95% of us are here to work together to make fellow members and members of the community safer and to keep sources doing the right thing. Obvious the other 5%(No Rich Piana pun intended) you can tell pretty quickly.

I'm just hoping the majority will see what we are trying to accomplish and support it.

I support our current lab completely and trust in the work they are doing. What other lab will bend over backwards and double, triple check and even send to another lab if you question the results. Most would say... That's it that's all you get.

mands

I for one am glad @mands and @Dr JIM are doing what your doing. I know you guys dont have an agenda.

Im grateful meso has you.

 

[Dr JIM]

The Serostim is real. EMD Serono allows anyone to check the validity of the products using the Check My Meds app. I scanned the picture of the box included.

And IF that is the case EMD is under dosing Serostims bc our ASSAYS are ACCURATE, and consequently matters of this nature will require much more than a tele-promted phone call!

And the FIRST order of business to clarify the issue will be; "where was the product purchased".

I know bc I've already spoken with their "distribution operations manager" who is VERY concerned …….. this fat lady has not sung!