Spaceman Spiff
Member
Pharma like Serostim has no vacuum. So I am not sure of where degradation claims are coming from.
MESO-Rx
Anabolic Steroids
The Lobster International, US and EU Domestic HGH, PEPTIDES and Turkish Pharmacy
- Thread starter TheLobster
- Start date
chumpsickel
New Member
I guess I will operate under the assumption that Lobster is taking all the same precautions as the makers of Serostim; he seems to be knowledgeable and I do feel comfortable with his product, I was just hoping to avoid the no vacuum batch.
For what I have understood the non vacuum batch are not present anymore but I'll let @TheLobster confirm it.
For pharma such as Serostim (instructions clearly state storage of lyophilized product at room temp) you don't need a vacuum in the vial once it has been stoppered since after lyo the vacuum is broken with an inert gas such as Argon.
No I didn't confirm with headspace GC on my vials but somatropin is oxygen sensitive. So my speculation is the headspace contains Argon.
For UGL, no idea. Perhaps the Lobster can share his thoughts on inert gas backfill and what he uses.
In case you want one for home:
No I didn't confirm with headspace GC on my vials but somatropin is oxygen sensitive. So my speculation is the headspace contains Argon.
For UGL, no idea. Perhaps the Lobster can share his thoughts on inert gas backfill and what he uses.
Why We Don't Use Nitrogen for Filling Lyophilized Vials? - Takvin Azmayesh Parseh
In the world of pharmaceuticals and biotech, lyophilization or freeze-drying plays a vital role in preserving sensitive products like vaccines and antibodies.
parsefreezedry.com
In case you want one for home:
Last edited:
Ghoul
Member
Vacuum is the poor man's method of protecting protein drugs from oxidation. It's easily lost via leaks, and never eliminates all the oxygen. Pharma replaces oxygen with an inert gas, like nitrogen, so there's no vacuum pressure on the stopper trying to suck air in, and it completely eliminates oxygen.
Oxygen damages rHGH, and almost all peptides. Once a growth hormone molecule is oxidized it no longer works, unfolds, and causes aggregates to form by making more rHGH stick to it, reducing efficacy even further.
The TLDR of this study was that the presence of oxidized rHGH makes the entire vial more susceptible to temperature degradation than it would be otherwise.
Methionine is the amino acid in rHGH most likely to be damaged by oxygen.
"The thermal melting of r-hGH and its oxidized products is a highly cooperative process. Methionine oxidation leads to a thermal destabilization of the whole protein folding and is not just a local destabilization."
"Oxidation is one of the major issues in the development of a biotech product which can occur during various steps of the development, upstream / downstream processing, filling, storage and handling. Aggregation is also a major issue that can reduce the yield during production, induce immunogenicity, toxicity and loss of activity."
Large aggregates can be removed with .2um filtering, lowering immunogenicity and the risk of developing immunity to growth hormone.
Last edited:
First MFers, haha!!
chumpsickel
New Member
That is great for those that ordered after, but where does that leave me? Maybe I should just up my dose and use it up before it possibly degrades.
Why don't you read the above and wait for Lobster to respond? Of course since I read the vacuum was restored on the manufacturing line he probably isn't using an inert gas backfill.
Ghoul
Member
Keep it cold and that will minimize further degradation, and filtering to remove the aggregates would be a good idea (it always is, but in this case especially).
Now that's an interesting one. Chemical kinetics tells us storing lyophilized UGL GH in the fridge (at the very least) is a no brainer. But then I get to thinking about any pesky residual moisture in the headspace that could condense. Probably doesn't outweigh the benefit of lowering the temp during storage.
Ghoul
Member
This is a good example of why people referencing pharma specs or clinical studies to determine stability of UGL peptides, or the amount of immunogenicity they can induce from aggregation is ridiculous.
The *least likely* thing to be the case is that they're even close to as stable and safe as pharma products would be.
Assume they aren't and filter to protect your long term health, or if you plan to die young and leave a good looking corpse, just filter so the shit works better.
You are making me feel better about that 600 bucks per 126 IU,
.I will have to probably give ole Lobster a try at some point.
Ghoul
Member
rHGH under ideal circumstances, like pharma made stuff, is pretty stable at room temp.
This study mentions oxidation damage of rHGH is a two step process. First, the chemical damage, oxidation of some proportion of rHGH exposed to oxygen.
Then the mechanical damage, as the oxidized rHGH easily unfolds at room temp, acting like double sided tape, making lots of other rHGH stick to it, forming aggregates, which ruins a much larger amount of rHGH and of course, induces an immune reaction when you inject those balls of growth hormone boogers. This part mostly takes place after reconstitution.
Keeping it cold will slow down the mechanical part of this slow motion disaster.
Or just go IDGAF, worked fine for me, and complain later about how much worse the sides are with a particular batch for some unknown reason.
With the right excipients, I agree. The early work at 25 deg C showed significant degradation after 3 months for lyophilized GH. Some nice figures in that paper. That study (Pikal 1991) was done under N2 headspace for the vials.
Tremendous early work on the importance of excipients and their role in GH formulations. This paper deals with protein stability and "shelf life" of freeze dried GH at 25 and 40 deg C.
pubmed.ncbi.nlm.nih.gov
Definitely worth the read. The old adage that lyophilized GH is good for 3 months at room temp isn't all its cracked up to be. At a minimum, ask your UG lab for mannitol, glycine and a buffer.
See also:
pubmed.ncbi.nlm.nih.gov
The effects of formulation variables on the stability of freeze-dried human growth hormone - PubMed
Formulation often has a dramatic effect on degradation of proteins during the freeze-drying process as well as impacting on the "shelf-life" stability of the freeze-dried product. This research presents the results of a formulation optimization study of the "in-process" and shelf-life stability...
pubmed.ncbi.nlm.nih.gov
Definitely worth the read. The old adage that lyophilized GH is good for 3 months at room temp isn't all its cracked up to be. At a minimum, ask your UG lab for mannitol, glycine and a buffer.
See also:
Effect of excipients on the stability and structure of lyophilized recombinant human growth hormone - PubMed
We have investigated the effect of mannitol, sorbitol, methyl alpha-D-mannopyranoside, lactose, trehalose, and cellobiose on the stability and structure of the pharmaceutical protein recombinant human growth hormone (rhGH) in the lyophilized state. All excipients afforded significant protection...
pubmed.ncbi.nlm.nih.gov
Last edited:
Spaceman Spiff
Member
so this is after reconstitution in water. Was this performed in powder form?
chumpsickel
New Member
I went back in the forum and read where there was talk about adding an inert gas to the headspace, but he did not confirm it, so I am assuming this did not happen.
I just meant read the above comments on inert gas. Yes you'll have to wait for Lobster to weigh in on his process.
TLDR: successful storage of lyophilized GH at room temp for months requires no oxygen headspace and proper excipient package.
I concur with @Ghoul, refrigerate the hell out of the UG stuff and feel free to throw the pharma stuff in fridge as well.
chumpsickel
New Member
Thank you for the TLDR, I am trying to do taxes and it was requiring too much focus. Wish I was better at multitasking.
Appreciate your honesty.
Tip: IMHO study the finer points of GH manufacturing when you got a few minutes of undivided attention
!Good luck with the taxes.
Ghoul
Member
They oxidized a small percentage of rHGH and added it to the non-oxidized rHGH, then reconstituted (at different PHs) and checked for degradation at different temps. In all cases the presence of oxidized rHGH led to much quicker and extensive degradation at temps rHGH would usually be stable.
To be a legitimate study they have to precisely control all the factors. They can't just pop off the top of a vial and then study the damage. It's well established if you expose peptide chains to oxygen certain amino acids in it will oxidize when exposed to oxygen, it doesn't need to be proven. That's why even UGL uses vacuum.
"Proteins and peptides are susceptible to oxidative damage through reaction of certain amino acids with oxygen radicals present in their environment. *Methionine, cysteine, histidine, tryptophan, and tyrosine are most susceptible to oxidation"
*this is where rHGH gets damaged on contact with oxygen.
Biopharmaceutical Product Stability Considerations, Part 1
Physical and chemical factors can affect biopharmaceutical product stability and quality, particularly after long-term storage in a container–closure system
Similar threads
