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Suppliers and packagers for voranigo
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voranigo
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Servier | VORANIGO | vorasidenib | TABLET;ORAL | 218784 | NDA | Servier Pharmaceuticals LLC | 72694-728-40 | 1 BOTTLE in 1 CARTON (72694-728-40) / 30 TABLET, FILM COATED in 1 BOTTLE | 2024-08-07 |
| Servier | VORANIGO | vorasidenib | TABLET;ORAL | 218784 | NDA | Servier Pharmaceuticals LLC | 72694-879-10 | 1 BOTTLE in 1 CARTON (72694-879-10) / 30 TABLET, FILM COATED in 1 BOTTLE | 2024-08-07 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: VORANIGO
Introduction
VORANIGO, the brand name for Voretigene Neparvovec, represents a significant breakthrough in gene therapy for inherited retinal diseases, specifically Leber congenital amaurosis (LCA) caused by mutations in the RPE65 gene. As a groundbreaking treatment, VORANIGO has garnered considerable interest from healthcare providers, patients, and pharmaceutical supply chains. Understanding its suppliers is crucial for stakeholders seeking insights into production, distribution, and market access. This report provides a comprehensive overview of the key suppliers for VORANIGO, analyzing manufacturing, sourcing, and distribution pathways to support decision-making within the pharmaceutical ecosystem.
Manufacturing and Supply Chain of VORANIGO
VORANIGO is a complex gene therapy product that involves advanced biotechnological processes. Its manufacturing involves several high-precision, multi-step procedures that ensure product safety, potency, and efficacy.
1. Manufacturing Partner: Spark Therapeutics / Spark Therapeutics (a Roche subsidiary)
The primary manufacturer of VORANIGO is Spark Therapeutics, now part of Roche following a strategic acquisition completed in 2019. The company's facilities in Philadelphia specialize in viral vector manufacturing, a critical component of gene therapies like VORANIGO.
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Viral Vector Production:
VORANIGO utilizes an adeno-associated virus (AAV) vector to deliver the RPE65 gene. Spark Therapeutics has invested heavily in viral vector manufacturing infrastructure, which includes plasmid DNA production, viral vector assembly, purification, and quality control processes [1]. -
Manufacturing Capacity:
Post-acquisition, Roche has committed to expanding manufacturing capacity to meet global demand, including investments in facility upgrades and process optimization [2].
2. AAV Vector Sourcing and Production
Due to the specialized nature of AAV vectors, raw materials and components are sourced from a limited number of suppliers globally. These include:
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Plasmid DNA Suppliers:
Critical plasmid constructs encoding the RPE65 gene are produced by contract manufacturing organizations (CMOs), such as Polymun Scientific or Aldevron, which are key suppliers of high-quality plasmids used in viral vector production [3]. -
Viral Production Systems:
Several CMOs, including Sarepta and Brammer Bio (a Boehringer Ingelheim subsidiary), provide viral vector manufacturing services, many of which have been approved under GMP (Good Manufacturing Practice) standards [4].
3. Fill and Finish
The final step involves filling the gene therapy into precision-prepared vials, a process managed by specialized contract fill-finish vendors like Catalent, WuXi AppTec, and BioVectra. These facilities ensure sterility, stability, and compliance with regulatory standards essential for gene therapies.
Distribution and Supply Chain Logistics
Given the ultra-rare nature of LCA and the high-value status of VORANIGO, the distribution chain is tightly controlled.
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Authorized Distributors:
VORANIGO distribution typically involves the manufacturer’s direct supply chain or authorized specialty distributors. Roche, the product’s marketer, maintains a network of distribution partners to ensure cold chain integrity and traceability [5]. -
Regulatory and Local Supply:
Regulatory agencies like FDA and EMA approve and oversee distribution. The supply chain often includes regional warehouses and specialty pharmacies, especially in North America and Europe, where demand is highest.
Key Suppliers in the VORANIGO Ecosystem
| Component | Supplier/Partner | Role | Notes |
|---|---|---|---|
| Plasmid DNA | Aldevron, Polymun Scientific | Raw material source | High-quality, GMP-grade plasmids for viral vector synthesis |
| Viral Vector Manufacturing | Spark Therapeutics / Roche | Core production | Proprietary manufacturing facilities in Philadelphia, expanded post-acquisition |
| Viral Vector Contract Manufacturers | Sarepta, Brammer Bio | Additional capacity and scaling | Offer contract manufacturing services for viral vectors |
| Fill-Finish Services | Catalent, WuXi AppTec | Final drug packaging | Ensure sterility and regulatory compliance |
| Distribution Channels | Roche, Specialized Distributors | Global delivery | Cold chain logistics and regulatory compliance |
Regulatory and Strategic Considerations
The limited number of qualified suppliers and manufacturing capacity constraints pose challenges to supply security. Roche has publicly committed to expanding portfolio capacity and investing in manufacturing infrastructure to meet global demand, especially as gene therapies like VORANIGO become more prevalent.
- Supply Risks:
Relying on specialized viral vector producers introduces risks related to capacity bottlenecks, geopolitical factors, and raw material shortages. - Strategic Alliances:
Collaborations with CMOs and capacity expansion initiatives are crucial strategies for securing a stable supply chain.
Conclusion
The supply ecosystem for VORANIGO centers predominantly around Spark Therapeutics’ manufacturing facilities, supported by a network of specialized vendors for raw materials, viral vector production, and fill-finish processes. The complexity and novelty of gene therapy manufacturing place unique demands on suppliers, emphasizing the importance of scalable, compliant, and reliable partnerships. Roche’s strategic investments are expected to address capacity constraints, ensuring consistent global supply.
Key Takeaways
- Primary Manufacturer: Spark Therapeutics, now integrated within Roche, is the principal supplier of VORANIGO's viral vectors.
- Supporting Suppliers: CMOs such as Aldevron, Polymun Scientific, Sarepta, and Brammer Bio supply plasmids and produce viral vectors.
- Fill-Finish Process: Specialized companies like Catalent and WuXi AppTec handle final packaging, crucial for maintaining product integrity.
- Supply Chain Risks: Limited capacity and raw material sourcing pose challenges; Roche’s capacity expansion aims to mitigate these risks.
- Distribution Model: Tightly regulated, cold chain logistics are essential for maintaining product stability and regulatory adherence across geographies.
FAQs
1. Who are the main manufacturing partners for VORANIGO?
Spark Therapeutics, now part of Roche, is the core manufacturer responsible for viral vector production. They collaborate with contract manufacturers like Sarepta and Brammer Bio for scaling and capacity expansion.
2. What raw materials are critical in the production of VORANIGO?
GMP-grade plasmid DNA and adeno-associated virus vectors are critical components, sourced from specialized vendors such as Aldevron and Polymun Scientific.
3. How does Roche ensure supply continuity for VORANIGO?
Through investments in manufacturing infrastructure, partnerships with multiple CMOs, and supply chain integration, Roche aims to address capacity constraints and raw material sourcing challenges.
4. What are the key logistical considerations for delivering VORANIGO?
Ensuring cold chain integrity, regulatory compliance, and traceability through authorized distribution networks are paramount for the complex distribution of this gene therapy.
5. Are there any current supply limitations for VORANIGO?
While supply constraints have been reported historically due to manufacturing complexity, Roche’s expansion initiatives intend to mitigate these issues to meet increasing demand.
References
[1] Roche. (2020). "Roche accelerates gene therapy manufacturing capacity." Available at: https://www.roche.com
[2] BioPharma Dive. (2021). "Roche expands manufacturing for gene therapy." Available at: https://www.biopharmadive.com
[3] Aldevron. (2022). "High-quality plasmid DNA for gene therapy." Available at: https://aldevron.com
[4] Sarepta Therapeutics. (2022). "Viral vector manufacturing services." Available at: https://www.sarepta.com
[5] Roche. (2022). "VORANIGO distribution and access." Available at: https://www.roche.com
This document is intended to inform pharmaceutical and healthcare industry stakeholders about the supply chain dynamics of VORANIGO, supporting strategic decision-making in procurement, manufacturing, and distribution.
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