Talazoparib Production Cost Reports

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

Talazoparib is an oral PARP inhibitor that traps PARP enzymes on damaged DNA strands to prevent repair. This leads to selective cancer cell death, particularly in tumours with BRCA mutations or other homologous recombination deficiencies. It is FDA-approved for adults with germline BRCA-mutated (gBRCAm) and HER2-negative locally advanced or metastatic breast cancer following anthracycline and/or taxane therapy. It is also used in combination with enzalutamide for HRR gene-mutated metastatic castration-resistant prostate cancer (mCRPC). It is dosed at 0.75 mg once daily with or without food, which requires monitoring for hematologic toxicities like anaemia and supportive measures like transfusions or dose adjustments.

The market for talazoparib is driven by rising cases of BRCA-mutated breast cancer and HRR gene-mutated prostate cancers. The growing use of genetic testing to find suitable patients and the fast expansion in regions like Asia-Pacific, from better diagnostics and healthcare improvements boosts its demand.

The industrial talazoparib procurement is affected by high yearly treatment costs, leading to payer negotiations and value-based deals. The strong supply control, particularly in hospitals, competition from other PARP inhibitors like olaparib or niraparib, and wider insurance coverage in North America and Europe impact its sourcing strategies. Other factors, like precision medicine trends and regulatory support for new cancer drugs, influence its market dynamics.

Raw Material for Talazoparib Production

According to the talazoparib production plant project report, the key raw materials used in the production of talazoparib include 4-amino-6-fluoroisobenzofuran-1(3H)-one, 4-fluorobenzaldehyde, and dioxane.

Production Process of Talazoparib

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

1. From 4-amino-6-fluoroisobenzofuran-1(3H)-one: The production process of talazoparib starts with 4-amino-6-fluoroisobenzofuran-1(3H)-one (formula 14) and 4-fluorobenzaldehyde. These chemical reacts in dioxane with PPTS and anhydrous MgSO4 at reflux, followed by cooling, methanol quench, filtration, and washing to get an intermediate. This is refluxed in absolute ethanol with D(-)-tartaric acid, cooled to precipitate the diastereomeric salt. This salt in anhydrous THF is treated with sodium alkoxide at reflux for 1-2 hours, followed by the addition of the triazole compound to give an advanced intermediate. Finally, this is refluxed in ethanol with 50% hydrazine hydrate to get talazoparib.

Talazoparib has the molecular formula of C19H14F2N6O with a molecular weight of around 380.35 g/mol for the free base. It appears as a white to off-white solid powder and is highly soluble in DMSO, with low aqueous solubility at neutral pH. It shows good oral bioavailability from capsules or tablets dosed at 0.75-1 mg daily for cancers like BRCA-mutated breast or prostate tumours. It has a chiral (8S,9R)-pyrido[4,3,2-de]phthalazin-3(7H)-one core with difluorophenyl and methyltriazolyl substituents. It has a LogP value of around 1.8 with 1 hydrogen bond donor, 8 acceptors, and undergoes hepatic metabolism via glucuronidation with high plasma protein binding ( around 74%).