The report provides a detailed analysis essential for establishing a Glasdegib production plant. It encompasses all critical aspects necessary for Glasdegib production, including the cost of Glasdegib production, Glasdegib plant cost, Glasdegib production costs, and the overall Glasdegib production plant cost. Additionally, the study covers specific expenditures associated with setting up and operating a Glasdegib 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.
Glasdegib is an innovative drug primarily used in the treatment of certain types of cancer, particularly acute myeloid leukaemia (AML). It is commonly used for the treatment of newly diagnosed acute myeloid leukaemia in adults aged 75 years or older who cannot receive intensive induction chemotherapy. It works by inhibiting a specific protein called the hedgehog signalling pathway, which is involved in the growth and survival of cancer cells. It is also used in combination with low-dose cytarabine to improve treatment outcomes for patients with AML who are not candidates for intensive chemotherapy. It is also being explored in the treatment of other cancers, such as basal cell carcinoma and other solid tumours.
The demand for Glasdegib is primarily led by its application as an important tool in precision medicine due to its ability to target cancer cell pathways, which promotes its market expansion. Its application as an oral drug in the treatment of acute myeloid leukaemia (AML), a type of cancer that affects the blood and bone marrow, also fuels its demand in the oncology sector. Its application in combination with other chemotherapy drugs to improve treatment outcomes for patients with AML who are not candidates for intensive chemotherapy also fuels its demand in the medical sector. Its application as a targeted therapy in combination therapies for other cancers, such as basal cell carcinoma, further boosts its demand in the healthcare and pharmaceutical industries.
Industrial Glasdegib procurement depends on factors such as the cost and availability of raw materials, regulatory approvals, and adherence to stringent safety and efficacy standards. Furthermore, advancements in production processes, reliable suppliers, sustainable production practices, and efficient distribution networks also play a significant role in shaping the global procurement processes for Glasdegib.
Raw Material for Glasdegib Production
According to the Glasdegib production plant project report, the major raw materials for Glasdegib production include Methoxypyridine, Methyl Triflate, and Maleic Acid.
Production Process of Glasdegib
The extensive Glasdegib production cost report consists of the following industrial production process:
- Production from Methoxypyridine: The production process of glasdegib begins with the conversion of methoxypyridine to a pyridinium salt using methyl triflate. This is followed by the synthesis of benzimidazole, which is lithiated and reacted with the pyridinium salt to form an enone. Then, the enone is reduced with LiAl(OtBu)3 and CuBr to form piperidone. Further, the piperidone undergoes a dynamic kinetic resolution (DKR)-based enzymatic transamination process with transaminase enzyme ATA-036, which provides the desired anti-amine in high yield and purity. Then, the reaction mixture is treated with imidazole solvate, which produces glasdegib in the free base form. Finally, glasdegib is converted into the maleate salt by reacting with maleic acid, which results in the formation of high purity glasdegib maleate.
Glasdegib appears as a white solid powder and is insoluble in water but exhibits good solubility in dimethyl sulfoxide. The molecular formula of the compound is C21H22N6O, and its molecular mass is 374.44 g/mol. Its density is approximately 1.3 g/cm3, and the compound has a boiling point of 633.4 degree Celsius at 760 mmHg and a flash point of 336.9 degree Celsius. It is a potent and orally bioavailable small-molecule inhibitor of the Hedgehog signalling pathway that acts by binding to and inhibiting the smoothened receptor. The crystalline base form of the compound has a melting point of approximately 237 degree Celsius. The compound was developed by Pfizer and is marketed under the trade name Daurismo. It is recommended to store the compound in dry, dark conditions at low temperatures to maintain stability. Prolonged use may cause serious health problems such as dysgeusia, muscle spasms, renal toxicity, QT interval prolongation, anaemia, fatigue, haemorrhage, and various other adverse effects, particularly in elderly patients.