Idelalisib Production Cost Reports

The report provides a detailed analysis essential for establishing an Idelalisib production plant. It encompasses all critical aspects necessary for Idelalisib production, including the cost of Idelalisib production, Idelalisib plant cost, Idelalisib production costs, and the overall Idelalisib production plant cost. Additionally, the study covers specific expenditures associated with setting up and operating an Idelalisib 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.

Idelalisib is a targeted pharmaceutical compound used mainly in the treatment of certain types of blood cancers. It is commonly applied in therapies for conditions like chronic lymphocytic leukaemia (CLL), follicular B-cell non-Hodgkin lymphoma, and small lymphocytic lymphoma, especially in patients who have not responded to other treatments. It works by blocking a specific enzyme called PI3K delta, which helps slow down or stop the progression of the disease. In clinical practice, it is used along with other cancer medicines to improve treatment response. It is also being explored in clinical research for potential applications in other blood-related malignancies and immune disorders.

The market for Idelalisib is primarily driven by its application as a precision medicine for patients requiring targeted therapies in cancer treatment, which fuels its demand in oncology. Its application as a targeted therapy in the treatment of specific blood cancers, including chronic lymphocytic leukaemia, follicular lymphoma, and small lymphocytic lymphoma, also promotes its demand in the pharmaceutical industry. Its ability to inhibit the PI3Kδ pathway provides a crucial treatment option for patients with relapsed or refractory conditions, which further strengthens its demand in oncology and related medical sectors.

Its usage as a reference compound in research work based on understanding immune system disorders and cancer cell behaviour also fuels its demand in patient care and scientific research centres. Factors such as the cost and availability of advanced intermediates and active pharmaceutical ingredients (APIs), along with compliance with regulatory requirements and evolving safety standards, significantly influence industrial Idelalisib procurement. Technological improvements in synthesis processes, supplier consistency, sustainable production practices, and secure global distribution channels also impact its procurement decisions.

Raw Material for Idelalisib Production

According to the Idelalisib production plant project report, the major raw materials for Idelalisib production include 2-fluoro-6-nitrobenzoic acid, Oxalyl Chloride, Aniline, N-Boc-L-2-aminobutyric Acid, and 6-Bromopurine.

Production Process of Idelalisib

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

1. Production via Chemical Synthesis: The production process of Idelalisib begins with the conversion of 2-fluoro-6-nitrobenzoic acid into its corresponding acid chloride using oxalyl chloride, followed by condensation with aniline in dichloromethane to form 2-fluoro-6-nitro-N-phenylbenzamide. Then, this intermediate is coupled with N-Boc-L-2-aminobutyric acid using oxalyl chloride to give a Boc-protected amino butyrate derivative. Further reduction of the nitro group using zinc and acetic acid produces the main quinazolinone core. Then, the Boc group is removed to expose the free amine, which is coupled with 6-bromopurine in the presence of DIPEA in t-BuOH to produce Idelalisib as the final compound.

Idelalisib is an anti-cancer drug classified as a selective phosphoinositide 3-kinase delta (PI3Kδ) inhibitor. It exists as a white to off-white solid and is practically odourless. The molecular formula of the compound is C22H18FN7O, and its molar mass is 415.42 g/mol. It is sparingly soluble in water but freely soluble in organic solvents such as methanol and dimethyl sulfoxide. The melting point of idelalisib is approximately 160 degree Celsius.

It undergoes hazardous decomposition, while releasing toxic gases like carbon dioxide, carbon monoxide, and nitrogen oxides. It is chemically stable under recommended storage conditions, which include protection from light, moisture, and high temperatures. Idelalisib can be harmful if ingested or inhaled, and appropriate safety precautions, including the use of gloves, masks, and lab coats, are advised while handling. Exposure to the compound may lead to gastrointestinal irritation, liver enzyme elevations, or more severe toxicities if mishandled.