Share This Page
Suppliers and packagers for abraxane
✉ Email this page to a colleague
abraxane
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Bristol-myers | ABRAXANE | paclitaxel | POWDER;INTRAVENOUS | 021660 | NDA | Abraxis BioScience, LLC | 68817-134-50 | 1 VIAL, SINGLE-USE in 1 CARTON (68817-134-50) / 20 mL in 1 VIAL, SINGLE-USE | 2005-02-10 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: ABRAXANE
Introduction
ABRAXANE (paclitaxel protein-bound particles) is a targeted chemotherapy medication developed by Celgene Corporation, now part of Bristol-Myers Squibb (BMS). It is primarily used for treating breast cancer, non-small cell lung cancer (NSCLC), and pancreatic cancer. As a complex biopharmaceutical, the manufacturing, sourcing, and supply chain for ABRAXANE are intricate, involving multiple specialized suppliers across various stages of production. This article provides an in-depth analysis of the key suppliers and their roles within the ABRAXANE supply network, market dynamics, and strategic considerations pertinent to stakeholders.
Manufacturing of Active Pharmaceutical Ingredient (API): Paclitaxel
1. Sourcing of Paclitaxel Raw Material
The fundamental component of ABRAXANE is paclitaxel, a taxane-class chemotherapeutic agent originally derived from the Pacific yew tree (Taxus brevifolia). Due to the complexity and sustainability concerns associated with natural extraction, most commercial paclitaxel is now produced via semi-synthetic or total synthetic methods, facilitated by chemical and biological processes.
Key Suppliers of Paclitaxel API:
-
Cambrex Corporation
Cambrex is among the leading suppliers of paclitaxel API globally, utilizing established semi-synthetic processes starting from plant-derived 10-deacetylbaccatin III. Its facilities in Italy and the U.S. supply pharmaceutical-grade paclitaxel to manufacturers for injectable formulations, including ABRAXANE [1]. -
Patheon (a division of Thermo Fisher Scientific)
Patheon, with manufacturing units across Europe and North America, supplies high-purity paclitaxel APIs tailored for oncology drugs. Their robust quality assurance processes ensure compliance with regulatory standards (e.g., cGMP). -
Jubilant Biosys (India)
Jubilant Biosys manufactures both small molecules and APIs, including paclitaxel, leveraging India's cost-advantage and emerging position in global pharmaceutical supply chains. Their APIs meet rigorous quality standards, and they serve as a significant source for generic formulations globally. -
Dr. Reddy’s Laboratories
This Indian pharmaceutical giant supplies generic paclitaxel APIs and formulations, frequently servicing markets where price competitiveness is essential [2].
Manufacture of Paclitaxel Protein-Bound Particles (Nanoparticle Formulation)
ABRAXANE’s proprietary formulation involves binding paclitaxel to albumin nanoparticles, necessitating specialized manufacturing capabilities:
2. Protein (Albumin) Suppliers:
-
Bayer CropScience / Biogen (former collaborators)
Bayer historically supplied recombinant human serum albumin (HSA) utilized in some nanoparticle formulations. However, specific sourcing of albumin for ABRAXANE is managed through licensed pharmaceutical grade suppliers, including: -
CSL Behring
CSL Behring provides pharmaceutical-grade human serum albumin, procured under strict regulatory standards (e.g., FDA, EMA). Their supply chain ensures high purity, necessary for oncological injectable drugs [3]. -
Octapharma and Grifols
These companies produce pharmaceutical-grade albumin, often used in nanoparticle formulations, including ABRAXANE. Their global sourcing capabilities ensure consistent supply.
3. Manufacturing of the Nanoparticle Formulation:
Bristol-Myers Squibb collaborates with contract manufacturing organizations (CMOs) specialized in nanotechnology and sterile injectable production:
-
Fujifilm Diosynth Biotechnologies
Known for biologics manufacturing, they provide expertise in nanoparticle formulation and sterile production processes for ABRAXANE. -
Lonza
Lonza’s sterile manufacturing facilities supply nanoparticle-based formulations, emphasizing Good Manufacturing Practices (GMP) compliance.
Supply Chain and Distribution Network
4. Contract Manufacturing Organizations (CMOs):
Beyond raw materials, CMOs form the backbone of ABRAXANE supply:
- Fujifilm Diosynth and Lonza produce the final nanoparticle formulation under strict regulatory oversight. Their facilities are cGMP-compliant and equipped for large-scale sterile manufacturing.
5. Packaging and Distribution:
-
PACKAGING Suppliers:
Trusted packaging companies like West Pharmaceutical Services provide sterile vials, stoppers, and closures compatible with ABRAXANE’s stability requirements. -
Distribution Channels:
Distribution to hospitals and pharmacies is managed through a global network of wholesalers, including McKesson, Cardinal Health, and AmerisourceBergen, ensuring timely delivery and inventory management.
Key Factors Influencing Supplier Selection and Supply Stability
-
Regulatory Compliance: Suppliers must adhere to stringent regulatory standards (FDA, EMA, PMDA) to ensure product safety and efficacy.
-
Quality Assurance: Given ABRAXANE’s indication for critical cancers, the consistent quality of APIs and excipients is non-negotiable.
-
Sustainability and Cost: Sourcing from India (e.g., Jubilant, Dr. Reddy’s) and China offers cost advantages, but supply security and regulatory acceptability are pivotal.
-
Technological Capabilities: The complexity of nanoparticle formulation requires suppliers with innovative R&D capabilities in nanotechnology and bioprocessing.
Emerging Trends and Risks
-
Supply Chain Disruptions: The COVID-19 pandemic exposed vulnerabilities in raw material sourcing and global logistics, leading to potential shortages. Diversification of suppliers and manufacturing sites is a strategic priority.
-
Regulatory Scrutiny: Increased regulation of biologics and nanomedicine components raises compliance costs and complicates supplier qualification.
-
Environmental and Sustainability Concerns: Sustainability initiatives targeting deforestation and environmental impact of natural paclitaxel extraction influence future raw material sourcing strategies.
Conclusion
The supply chain for ABRAXANE involves a multifaceted network of specialized suppliers across the spectrum of raw materials—paclitaxel API, human serum albumin, nanoparticle formulation technology, packaging, and distribution. Leading API manufacturers such as Cambrex, Jubilant, and Patheon ensure core API supply, while biologics and nanotechnology companies like CSL Behring, Lonza, and Fujifilm facilitate the assembly of ABRAXANE’s proprietary formulation. The integrated collaboration among these suppliers, combined with rigorous regulatory oversight and strategic diversification, underpins the robust global supply of this vital chemotherapeutic.
Key Takeaways
-
Diverse Supplier Base: ABRAXANE relies on multiple Tier-1 suppliers for its raw materials, ensuring resilience against disruptions.
-
Specialized Capabilities are Critical: The complexity of nanoparticle formulation necessitates partnerships with highly specialized CMOs and biopharmaceutical manufacturers.
-
Regulatory and Quality Standards Drive Supplier Selection: Only suppliers with proven compliance histories meet the criteria for high-stakes oncology drugs like ABRAXANE.
-
Supply Chain Resilience is a Top Priority: Companies are actively diversifying suppliers and manufacturing sites in response to pandemic-related and geopolitical risks.
-
Technological Innovation Influences Future Sourcing: Advances in synthetic paclitaxel, biosynthesis, and nanotechnology are likely to reshape supplier landscapes.
FAQs
1. Who are the primary API suppliers for ABRAXANE?
Cambrex, Jubilant Biosys, Patheon, and Dr. Reddy’s Laboratories are key suppliers providing high-quality paclitaxel APIs, with Cambrex being the most prominent for pharmaceutical-grade paclitaxel used in ABRAXANE.
2. How does ABRAXANE’s formulation influence its supply chain?
Its nanoparticle albumin-bound formulation requires specialized production facilities and premium pharmaceutical-grade albumin, involving collaborations with biotech companies like CSL Behring and CMOs with nanotech capabilities.
3. Are there sustainability concerns associated with paclitaxel sourcing?
Yes. Historically extracted from Pacific yew trees, manufacturing now primarily uses semi-synthetic or total synthesis methods to mitigate environmental impact and ensure sustainable supply.
4. What risks threaten the supply of ABRAXANE globally?
Risks include raw material shortages, manufacturing disruptions, geopolitical factors, logistical delays, and regulatory hurdles—prompting companies to develop diversified supply chains.
5. How might future innovations impact ABRAXANE’s supply chain?
Advances in synthetic biology and nanotechnology could reduce reliance on natural sources, streamline manufacturing, and introduce new suppliers with enhanced capabilities, improving supply stability.
Sources
[1] Cambrex Corporation Annual Reports, 2022.
[2] Dr. Reddy’s Laboratories Corporate Overview.
[3] CSL Behring Product Portfolio and Quality Standards Disclosure.
More… ↓
