Etelcalcetide Production Cost Reports

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

Etelcalcetide is a synthetic peptide-based drug primarily used to manage secondary hyperparathyroidism in patients with chronic kidney disease undergoing haemodialysis. It is primarily prescribed for patients with secondary hyperparathyroidism who are undergoing hemodialysis due to chronic kidney disease. It is also used as a therapeutic drug in the medical field for the management of mineral and hormone disorders. Its main function is to bind and activate calcium-sensing receptors on the parathyroid gland, thereby reducing the secretion of parathyroid hormone (PTH). It helps maintain calcium and phosphorus balance in the body, which is important for patients on dialysis. It is administered intravenously at the end of dialysis sessions, which makes it suitable for patients receiving regular dialysis care. Moreover, it plays an important role in improving bone health and minimising cardiovascular risks associated with elevated PTH levels.

The demand for Etelcalcetide is largely driven by its usage as a medication for managing secondary hyperparathyroidism (SHPT) in adults with chronic kidney disease (CKD), which promotes its market expansion. Its application as a drug in the treatment of secondary hyperparathyroidism in patients with chronic kidney disease who are undergoing haemodialysis significantly supports its demand in the medical and pharmaceutical industries. Its usage for lowering parathyroid hormone levels to help control abnormal calcium and phosphorus balance in the body largely boosts its demand in the hospital dialysis centres and speciality clinics.

Its demand as a drug to support long-term disease control and improve treatment outcomes for patients with advanced kidney-related conditions largely contributes to its market growth. In addition, industrial Etelcalcetide procurement is influenced by factors related to drug formulation requirements, regulatory approvals, and quality standards for injectable medicines. Manufacturing capabilities, supplier consistency, cold-chain logistics, and compliance with safety and sustainability guidelines also play a key role in shaping its procurement decisions at the global level.

Raw Material for Etelcalcetide Production

According to the Etelcalcetide production plant project report, the major raw materials for Etelcalcetide production include L-cysteine and N-chlorosuccinimide (NCS).

Production Process of Etelcalcetide

The extensive Etelcalcetide production cost report consists of the following industrial production process:

1. Production from L-Cysteine: The production process of Etelcalcetide begins with the preparation of a heptapeptide precursor, which is then directly coupled with L-cysteine in the presence of N-chlorosuccinimide (NCS) to form the disulfide bond. This method avoids the need to pre-form and isolate reactive intermediates like Boc-L-Cys(SCl)-OtBu. The reaction proceeds cleanly in both solution and solid phase, without any side reactions like homodimer formation.  This direct coupling approach results in the formation of only the desired high-purity Etelcalcetide, without any by-products.

Etelcalcetide is a synthetic peptide calcimimetic agent that appears as a white to off-white powder when formulated as the hydrochloride salt. The molecular formula of the compound is C38H73N21O10S2, and its molecular weight is 1048.26 g/mol. It is soluble in water and is administered as a sterile, preservative-free, clear and colourless solution for intravenous injection at a concentration of 5 mg per mL. The compound primarily consists of D-amino acids rather than the naturally occurring L-amino acids. It is marketed under the brand name Parsabiv. The compound may cause severe hypocalcemia, which can lead to serious complications. It is contraindicated in patients with serum calcium levels below the normal range. Extended exposure to this medication may cause serious health problems, including paresthesias, muscle spasms, seizures, QT interval prolongation, ventricular arrhythmia, nausea, vomiting, diarrhoea, and hypersensitivity reactions. The pharmaceutical preparation must be stored in a refrigerator at 2 to 8 degrees Celsius in the original carton to protect from light. Once removed from refrigeration, it should be used within seven days if kept in the original carton or within four hours if removed from the carton.