Western-BioTech - Pharma quality GH

I think what is important is what we have learned I mean in the end isn't that why we are here? I mean seriously having opinions is great but I'll take facts and testing and experience over just a random opinion any day of the week.
 
Pics prove you actually have a lab K, and the longer their posting is delayed the more likely others will believe those pictures were of some other facility.

And your right about one thing we are not talking about a lab the size of a garage to manufacturer GH.

I've another question. You keep referring to this facility as being FDA approved in one way fashion or form. FDA approved for what?

Oh sorry another question if you don't mind. Did you post labs that were analyzed under your direction on Meso?

If such is the case where (page or post number) can they be viewed?

Safety issues, such as?

Regs
JimJim
 
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Has Karl posted any of his *own* HPLC test results? He's referred to posting these results but I've been unable to locate them.



It's important to realize that we run the most sophisticated QA (quality assurance) in our facility, I posted our in house testing results to this batch at the beginning, they match the independent results posted here later of course. We test each step in the production like I showed to confirm the purity and potency, not just the final product.
 
Pics prove you actually have a lab K, and the longer their posting is delayed the more likely others will believe those pictures were of some other facility.

And your right about one thing we are not talking about a lab the size of a garage!

I've another question. You keep referring to this facility as being FDA approved in one way fashion or form. FDA approved for what?

Oh sorry another question if you don't mind. Did you post labs that were analyzed under your direction on Meso?

If such is the case where (page or post number) can they be viewed?

Safety issues, such as?

Regs
JimJim
Has Karl posted any of his *own* HPLC test results? He's referred to posting these results but I've been unable to locate them.

Nope.. And he said he'd post pics once before as well...
 
I'm not at he location of the lab, or I would take pics now, weeks ago I explained clearly my concerns regarding authentic pics from my lab to the admin, as well to another member here, lightspan I think is the name.
Aanyhow I said clearly - I'll be there after weekend and post pics, the more u dig on this insignificant pics issue, compared to the extensive lab tests that were done, and will be done, the more I regret I cooperate with u, as this is my team's safety on the line

I've never said my facility is FDA proved.

I don't understand the 3rd issue you asked me about
 
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Attached again a brief description on the manufacturing process (as Lighspan requested back then) along with our in house lab tests, note the last test which is very unique in this field - the biological assay test, if necessary I'll specify more on this regard
 

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Attached again a brief description on the manufacturing process (as Lighspan requested back then) along with our in house lab tests, note the last test which is very unique in this field - the biological assay test, if necessary I'll specify more on this regard

Well ok u did some tests on cells E-Coli I presume, that were supposed to be capable of producing a recombinant form of HGH, right.

Then you performed chromatography to elute wanted (GH) from unwanted (pretty much every ing else involved in the GH manufacturing process) a
and I suppose thereafter you performed Molecular weight analysis using either PEP or MS, right.

(There may be more data posted that I can't visualize since the copies are relatively faint)

BUT there still one huge problem which should be included in the
analytical process for those manufacturing GH and those are; an Amino Acid assay AND a protein sequence analysis.

Because in their absence I COULD contend you manufactured molecular steak slivers with a purity of X and a MW of X.

Now I looked over MANDS tests and indeed they did an AA assay yet no peptide sequence was performed.

(In fairness to MANDS he was only TESTING a product while K is producing it and the requirements are much more difficult to achieve in the latter)

I will also say whoever performed MANDS testing definitely knew what they were doing, since NO ONE has gone to such lengths on any forum I've seen.

Incidentally what does the abbreviation SDS represent since I've not heard of it as an analytical method in chemistry, but I'm getting old :)

Regs
Jim
 
Gosh I'm sorry to keep reporting but where is your "control" marker in the SEC and from what I'm seeing here the MW of all pods (blue lines) rest BETWEEN 17-20 KD!

That's a REAL problem bc rHGH should have a MW of 22 Kd?

Look at MANDS PEP for comparison...... yep 22Kd

Regs
Jim
 
Anyone may google now "SDS-page" and learn about this analytic method, I'm sorry if you haven't heard of it, but I'm happy that you joined us to get more knowledge, and contribute from your own

SDS-page enables to clarify accurately the purity of the HGH, and was in use by Mands lab as well.

If u examine our in house testing you won't find there actually MS, but we used it at the beginning of our venture to confirm some details, so I may ask for our MS (Mess Spec) and post it as well, this won't give a thorough picture as SDS-page for this purpose. Regarding Mands MS my professor actually asked to confirm the following - Pls check again how this vial was solubilized and what was the extinction (optical density) at 280 nm using quvette with 1 cm path. The extinction of hGH solution at concentration of 1 mg per ml should result in a value of 0.74.

Mands surely did here the most comprehensive lab test that can be done on GH
 
Gosh I'm sorry to keep reporting but where is your "control" marker in the SEC and from what I'm seeing here the MW of all pods (blue lines) rest BETWEEN 17-20 KD!

That's a REAL problem bc rHGH should have a MW of 22 Kd?

Look at MANDS PEP for comparison...... yep 22Kd

Regs
Jim

Ok - now everyone pls inspect the chart on attachment GN1 from my lab - the end of the shade sits perfectly between 20-25 just as it should,

Now pls doc, pls ....... if you have any doubts pls write to me in person to confirm any info, u simply confuse here everyone with terms and methods which they're not really familiar with, and you said yourself that you have never heard on SDS, so pls ....
 
Ok - now everyone pls inspect the chart on attachment GN1 from my lab - the end of the shade sits perfectly between 20-25 just as it should,

Now pls doc, pls ....... if you have any doubts pls write to me in person to confirm any info, u simply confuse here everyone with terms and methods which they're not really familiar with, and you said yourself that you have never heard on SDS, so pls ....

I think we all prefer this done out in the open, Karl.. :)
 
Forgive me guys, I'm on my way to the airport, I'll try to log in again from there, I enjoy every minute with u, if not will be back 2morrow. I just asked the doc to talk to me before posting things he's not yet to be sure before he may confuse you here, you may all assume that my professor showed the SDS chart as it should, and we wouldn't find new GH which sits on 17 instead of 22 and post with glory ....
 
GEP is the term most chemist use I know and it is best used to determine a substances MW and not it's purity,

You must perform chromatography for the latter.

I'll be back ;)

That protein AA and AA sequence K?
 
Nope the MW marker is considered the meniscus of the gel K and although most have a poorly demarcated meniscus the BEST example is NUMBER FOUR and it lies BETWEEN a. MW of 17 and 20.

There is no way looking at marker four one would surmise it lies between the 20-25 MW markers.

Jim
 
Doc - not sure if u tried to ask me if protein is AA (amino Acid) sequesnce ?

Regarding the AA my professor asked to clarify -

(1) Pls report accurately how the sample was prepared for amino acid analysis to allow calculation of protein content. The present explanation is not clear. Pls also explain why an internal standard such as nor-leucine was not used.
(2) Consider performing amino acid analysis to validate the amount of protein based on amino acid content. If you do so I shall give you advice how it should be done.

Regarding the numbers on the SDS-page - you're of course right and I'm wrong, lucky us Mands found on our GH that we made it somehow perfectly on 22.106,
 
Then you performed chromatography to elute wanted (GH) from unwanted (pretty much every ing else involved in the GH manufacturing process) a and I suppose thereafter you performed Molecular weight analysis using either PEP or MS, right.


If u examine our in house testing you won't find there actually MS, but we used it at the beginning of our venture to confirm some details, so I may ask for our MS (Mess Spec) and post it as well, this won't give a thorough picture as SDS-page for this purpose.


sciroxx-lab;1960579 said:
Regarding the by Mands -

My professor was deeply impressed with how thorough and complete were the tests, we don't run a mess spec in our quality assurance unit, so the tests are above any beyond any doubts and the most complete.

http://www.professionalmuscle.com/f...-quality-gh-sciroxx-group-19.html#post1960579


So have you run a mass spec or not? I quoted you saying you "do" and "don't" run Mass specs. I'm a little confused here. Can you explain the discrepancy? Thanks
 
The meniscus issue is also the reason a control lane should be present.

K I'm most certainly familiar with PEP and or GEP it's the fact you often use the abbreviation "SDS" in isolation that I was unfamiliar with.

Fact is wasn't my question, a clear reference to SDS.

Regarding the performed by MANDS people, it's about as inclusive as I've ever seen
Doc - not sure if u tried to ask me if protein is AA (amino Acid) sequesnce ?

Regarding the AA my professor asked to clarify -

(1) Pls report accurately how the sample was prepared for amino acid analysis to allow calculation of protein content. The present explanation is not clear. Pls also explain why an internal standard such as nor-leucine was not used.
(2) Consider performing amino acid analysis to validate the amount of protein based on amino acid content. If you do so I shall give you advice how it should be done.

Regarding the numbers on the SDS-page - you're of course right and I'm wrong, lucky us Mands found on our GH that we made it somehow perfectly on 22.106,

=============••••======
Let me see if I have the right? Your company is making the GH yet did NOT show evidence or proof what you produced was GH because you DID NOT perform the correct tests such as an AMINO ACID ANALYSIS or PROTEIN SEQUENCE ASSAY?

So your "professor" justifies his inadequate testing by criticizing another lab (MANDS) which did one test (AA analysis) that your company should have completed.

You believe that's the best way to legitimize your GH product K? Criticize another lab, that if anything aided your company?

It's ironic how some generic GH producers CLAIM THEIR GH has a purity that exceeds Pharm grade yet do so without performing the very tests that DEFINE PURITY,

So yea I believe the problem with generic GH producers is always the same QUALITY ASSURANCE and NONE have it!

Regs
Jim
 
Regarding the numbers on the SDS-page - you're of course right and I'm wrong, lucky us Mands found on our GH that "WE" made it somehow perfectly on 22.106,

Yea I agree Mands, using MS, had another lab confirm the molecular weight of the sample he submitted weighed 22,106 Daltons, and also confirmed the sample consisted almost exclusively of Amino Acids, in proportions similar to rHGH.

One thing no lab is capable of doing however is determine the manufacturer of a submitted sample, including "WE", or excluding the possibility a Pharm Grade GH product has been substituted as "generic" for analysis to enhance sales until enough suckers have "bought in".

Regs
Jim
 
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