Afamelanotide Production Cost Reports

The report provides a detailed analysis essential for establishing an Afamelanotide manufacturing plant. It encompasses all critical aspects necessary for Afamelanotide production, including the cost of Afamelanotide production, Afamelanotide plant cost, Afamelanotide production costs, and the overall Afamelanotide manufacturing plant cost. Additionally, the study covers specific expenditures associated with setting up and operating an Afamelanotide production plant. These encompass manufacturing processes, raw material requirements, utility requirements, infrastructure needs, machinery and technology requirements, manpower requirements, packaging requirements, transportation requirements, and more.

Afamelanotide is a medication used to treat phototoxicity in adults with a rare condition called erythropoietic protoporphyria (EPP), which causes severe pain and skin reactions when patients are exposed to sunlight. It works by stimulating the production of a pigment in the skin called melanin, which helps to protect the skin from the harmful effects of sunlight. It is a synthetic 13-amino acid peptide that is the first of its kind to mimic the effects of endogenous alpha-melanocyte-stimulating hormone (α-MSH).

The market for Afamelanotide is driven by its usage as a melanocortin-1 receptor agonist used for the treatment of erythropoietic protoporphyria in adults, which significantly promotes its demand in the pharmaceutical and medical industries. The widespread occurrence of phototoxicity due to erythropoietic protoporphyria is significantly increasing the demand for Afamelanotide. Additionally, the approval of the drug for the treatment of diseases apart from EPP, for instance, polymorphic light eruption, vitiligo, acne vulgaris, Hailey-Hailey disease, and solar urticaria enhance the market size. Moreover, the drug exhibits the efficacy of anti-inflammatory and this makes the drug a potential therapy for other photosensitive dermatological disorders which are unresponsive to other treatments, thus driving the demand. Overall, industrial Afamelanotide procurement is influenced by its application in the pharmaceutical and medical industries, rising cases of EPP, off-label uses, anti-inflammatory action, and regulatory approvals.

Raw Material for Afamelanotide Production

According to the Afamelanotide manufacturing plant project report, the key raw material used in the production of Afamelanotide includes Rink-Amide-AM-resin.

Manufacturing Process of Afamelanotide

The extensive Afamelanotide production cost report consists of the following major industrial manufacturing process:

1. Production from Rink-Amide-AM-resin: The manufacturing process of Afamelanotide starts with the HMBA linker being installed under standard condensation conditions with the presence of HOBt and base DIC to form modified HMBA-Rink-Amide-AM-resin. The resulting compound undergoes hydroxy esterification with Fmoc-Val-OH to form an intermediate. The intermediate is treated with DBLK realized N-Fmoc deprotection, followed by a condensation reaction with Fmoc-Pro-OH to give another intermediate. Following the same procedure, Fmoc-Lys(Boc)-OH is used to synthesize the polypeptide chain Ac-Ser-Tyl-Ser-Nle-Glu(OtBu)-His(trt)-D-Phe-Arg(pdf)-Trp(Boc)-Gly-Lys(Boc)-Pro-Val-MBA-Rink- Amide-AM-resin. Finally, the resin undergoes pyrolysis, hydrolysis of the protecting group, and amide condensation to produce Afamelanotide.

Afamelanotide is commercially known as Scenesse. It has the molecular formula C78H111N21O19 and a molecular weight of 1646.8 g/mol. It has an estimated water solubility of 0.023 mg/mL. It has a log P value of -1.4. The value of its dissociation constant, pKa, is 3.46. It is a 13-amino acid peptide analog of the endogenous alpha-melanocyte-stimulating hormone (α-MSH). It differs from α-MSH by two amino acids, enhancing its binding affinity to the melanocortin-1 receptor (MC1R) and providing a longer biological half-life and increased potency. It is used to reduce pain and itching from exposure to light in individuals with X-linked and erythropoietic protoporphyria by promoting the formation of melanin in the skin.