The report provides a detailed analysis essential for establishing a Sotorasib production plant. It encompasses all critical aspects necessary for Sotorasib production, including the cost of Sotorasib production, Sotorasib plant cost, Sotorasib production costs, and the overall Sotorasib production plant cost. Additionally, the study covers specific expenditures associated with setting up and operating a Sotorasib 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.
Sotorasib is a cancer medicine that is made for patients who have a specific change in their cancer cells called the KRAS G12C mutation. This mutation causes the cancer cells to grow and multiply quickly. It works by sticking to this mutated part of the cancer cell and turning it off, which stops the cancer from growing. It is usually taken as a daily pill, making it easier to use compared to some other cancer treatments. It is utilised for certain lung cancers and colon cancers where other treatments may not have worked.
It causes less harm to normal healthy cells, which means fewer side effects. It is being explored with other medicines to make it even more effective. Its common side effects are diarrhoea, muscle or bone pain, nausea, tiredness, and cough.
The market drivers for Sotorasib include the need for effective treatments for cancers with the KRAS G12C mutation. Its utilisation in managing non-small cell lung cancer (NSCLC) and colorectal cancer contributes to its market growth. Its status as the first FDA-approved targeted therapy boosts its market. The growing cases of lung and colorectal cancers have increased genetic testing to identify eligible patients, and expansion into new geographic markets also fuels its demand.
Also, ongoing research and clinical trials exploring combination therapies improve their market potential. The industrial Sotorasib procurement is affected by regulatory approvals, pricing and reimbursement policies, and competition from other emerging KRAS inhibitors. Its market growth is largely concentrated in the US, Europe, and is expanding in Asia, supported by significant investment in oncology drug development and patient access programs.
Raw Material for Sotorasib Production
According to the Sotorasib production plant project report, the key raw materials used in the production of Sotorasib include Nicotinic Acid Derivatives-Oxalyl Chloride-Aminopyridine-(3-Fluoroanisole).
Production Process of Sotorasib
The extensive Sotorasib production cost report consists of the following major industrial production process:
- From Nicotinic Acid Derivatives: The production of Sotorasib involves several steps. It starts with the amidation of a nicotinic acid derivative to form nicotinamide. This is followed by a classical resolution step to obtain atropisomerically pure intermediates. After that, preparation of a boroxine reagent from 3-fluoroanisole through deprotonation, boronation, and demethylation reactions takes place. Finally, these intermediates go through a series of coupling reactions, including SNAr and Suzuki coupling with the boroxine reagent, Boc deprotection, and amidation with acryloyl chloride to form the acrylamide moiety characteristic of sotorasib. The final compound is isolated by recrystallisation, giving pure sotorasib as the final product.
Sotorasib is a white to yellow solid with the molecular formula C30H30F2N6O3 and a molecular weight of 560.6 g/mol. It has a pKa of around 8.06 and 4.56, indicating ionisable groups. It shows pH-dependent solubility, with higher solubility under acidic conditions that decreases significantly at neutral to slightly acidic pH.
It has moderate lipophilicity with a logP around 5.7, a topological polar surface area of approximately 103 Ų. It has one hydrogen bond donor, seven hydrogen bond acceptors, and three rotatable bonds. It is stable as a solid and formulated as film-coated tablets, typically supplied in 120 mg doses for oral administration. All these properties contribute to its effectiveness as an orally bioavailable, selective, and irreversible covalent inhibitor of the KRAS G12C mutant protein in cancer treatment.
