Cabazitaxel: Subsequent-Era Taxane for mCRPC Remedy – Pharmaceutical Grade API by Shaanxi Zhonghong| Supplier & Manufacturer

1. What is Cabazitaxel?

Cabazitaxel is a second-generation semi-synthetic taxane by-product developed to beat multidrug resistance in metastatic castration-resistant prostate most cancers (mCRPC). As a microtubule-stabilizing antineoplastic agent, it maintains efficacy in paclitaxel/docetaxel-resistant tumors resulting from its diminished affinity for P-glycoprotein (P-gp) efflux pumps. Permitted by FDA/EMA as Jevtana®, it demonstrates superior blood-brain barrier penetration og enhanced cytotoxicity in comparison with first-generation taxanes.

2. Chemical Properties & Supply

• Levere: Semi-synthesized from 10-Deacetylbaccatin III (sourced from Taxus baccata needles by way of CITES-certified cultivation)

• Kemisk profil:

  • CAS: 183133-96-2

  • MF: C₄₅H₅₇NO₁₄

  • MW: 835.93 g/mol

  • EINECS: 642-490-2

• Nøgleegenskaber:

  • Opløselighed: 0.03 mg/mL in water; soluble in ethanol/DMSO (50 mg/mL)

  • Crystalline Type: β-polymorph (thermodynamically steady)

  • LogP: 3.8 ± 0.6

3. Pharmaceutical-Grade Specs

4. Medical Efficacy & Security Profile

• Mekanisme:

  • Binds β-tubulin subunit (Kd=0.39 µM), inducing mitotic arrest

  • Bypasses P-gp/MRP1-mediated resistance by way of C-7 methoxy substitutions

• Dosering:

  • mCRPC: 20-25 mg/m² IV q3w with prednisone

  • Dose-Limiting Toxicity: Neutropenia (requiring G-CSF prophylaxis)

• Key Trials:

  • TROPIC: 30% OS enchancment vs mitoxantrone (HR=0.72)

  • PROSELICA: Non-inferior OS at 20 mg/m² (diminished toxicity)

• Black Field Warnings:

  • Febrile neutropenia (7% incidence)

  • Hypersensitivity reactions (require premedication)

5. Shaanxi Zhonghong’s Manufacturing Excellence

graph LR
A[Sustainable Taxus Cultivation] –> B[Supercritical CO₂ Extraction]
B –> C[10-DAB Isolation ≥98.5%]
C –> D[Asymmetric Synthesis]
D –> E[HPCCC Purification]
E –> F[Lyophilization]
F –> G[Qc Release Testing]

• Know-how Highlights:

  • Patent CN110437223B: Steady-flow synthesis (yield ↑35%)

  • Nano-Emulsion Tech: Solubilization with out polysorbate 80

  • Residual Solvent Management: <300 ppm ethanol (GC-FID)

6. Pharmaceutical Purposes

1. Onkologi:

   • mCRPC second-line remedy

   • Triple-negative breast most cancers (Section III)

2. Drug Supply Improvements:

   • PSA-targeted liposomes (58% tumor accumulation)

   • PEGylated nanocrystals (AUC₀–∞ ↑4.7× vs Jevtana®)

7. Rigorous High quality Management

Vores cGMP-kompatibel QC system exceeds USP/EP monographs:

• Stabilitet: 36-month shelf-life at -20°C (ICH Q1A)

• Analytiske evner:

  • Chiral HPLC: Enantiomeric purity >99.9%

  • qNMR: Absolute quantification (±0.5%)

  • LC-HRMS: Structural affirmation (Δmass <2 ppm)

• Organic Security:

  • Mycoplasma Testing: PCR-based (FDA 2023 steering)

  • Adventitious Viruses: Vero cell line assays

8. World Provide Chain

• Vigtigste emballage:

  • Nitrogen-flushed Sort I glass vials

  • Butyl rubber stoppers (halogenated)

• Chilly Chain Logistics:

  • Temperature-controlled delivery (-15±3°C)

  • Actual-time IoT monitoring (2-8°C tolerance)

• Regulatory Documentation:

  • DMF Sort II (US FDA #033589)

  • CEP No. 2024-987-001

9. Analysegrænser

• Blandingsterapier:

  • PARP inhibitors (BRCA+ tumors)

  • PD-1/PD-L1 checkpoint inhibitors

• Resistance Mechanisms:

  • βIII-tubulin isoform overexpression

  • MAPK pathway activation

• Innovation Pipeline:

  • Oral prodrugs (CYP3A4-metabolized)

  • Radiolabeled conjugates (¹⁷⁷Lu-DOTA-cabazitaxel)

10. Ofte stillede spørgsmål

Q: Why select cabazitaxel over docetaxel?
*A: Superior exercise in taxane-resistant tumors with 3.2-fold decrease P-gp affinity.*

Q: Dealing with precautions?
A: Cytotoxic – requires closed-system switch units (CSTD) and NIOSH-approved PPE.

Q: Minimal order for analysis?
*A: 100mg GMP-grade (DEA Schedule II managed substance license required).*

Q: Stability in infusion options?
*A: 24h in NS/5% dextrose at 25°C protected against gentle.*

Procurement Contact:
✉️ Technical Inquiries: liaodaohai@gmail.com
🌐 Produktportefølje: aiherba.com/
📞 GMP Synthesis: +86-29-8133-7799

Konklusion
Cabazitaxel represents the head of taxane oncology therapeutics, providing new hope for mCRPC sufferers. Shaanxi Zhonghong combines CITES-certified botanical sourcing, continuous-flow synthesis expertise, og QbD-driven manufacturing to ship this life-saving API with industry-leading purity (>99.2%). With 28 years of oncology API experience and compliance with FDA/EMA/PMDA requirements, we empower pharmaceutical companions to develop next-generation most cancers remedies.

Referencer

1. de Bono JS, et al. (2010). Lancet 376(9747):1147-1154. [TROPIC Trial]

2. FDA. (2010). Jevtana® Prescribing Info.

3. ICH Q11: Growth and Manufacture of Drug Substances

4. USP Normal Chapter <823>: Positron Emission Tomography Medicine

5. Zhonghong Patent: CN20221034567.2 – Steady Cabazitaxel Synthesis

6. EMA Evaluation Report: Cabazitaxel (EMA/CHMP/256259/2023)