HGH in technical terms.
HGH is large, a complex protein made in a cell culture using biotechnology-a process that is enormously more complex and different from manufacture of other types of generic drugs such as diuretics and blood pressure medicines. HGH is produced with delicate biological cultures using living cells replicating in complex mixtures of cell nutrients. It is difficult to ensure that any two protein cultures will produce identical molecules with the same 3-dimensional configuration in the final product.Purification and handling of proteins produced in cell cultures can cause variations in folding, unfolding, cross-linkages, and variable aggregates of multiple proteins hooked together as dimers and polymers. These can cause immune responses and allergy to HGH, even endogenously produced HGH by the pituitary gland. Extraction and purification are very complex and expensive. Tiny residues from the cell culture can contaminate the end-product. It is relatively easy to get hormone activity, but extensive testing and quality control is required to insure safety for any new follow-on protein biological (FOPP) such as generic HGH.
To be completely safe, dimers, polymers, aggregates, improper folding, glycosylation, broken cross-linkages, pyrogens, and contaminants must be strictly limited during manufacture and packaging. The HGH molecule is fragile. Freeze drying and other steps in the packaging and distribution process can alter its structure. Such abnormalities may not block hormone activity, and the end product may seem to work quite well, but the altered molecules may stimulate immune reactions and cause allergy and desensitization to HGH over time, with subsequent and permanent loss of hormone response in the body. Adverse reactions may also include rashes.
Recombinant human growth hormone is manufactured in cell cultures and is a very large protein with a molecular weight greater than 22,000. It is composed of more than 190 amino acids linked together in a very precise order, then folded and cross linked at strictly defined locations. The result is growth hormone activity identical to that produced in the human pituitary gland. The 3-dimensional shape must be exact for proper effect-much like a key that must be in exactly the right shape to open a lock. Molecular variations in HGH may have hormone effect but can stimulate rejection by the immune system.
