izervay: Pharmaceutical manufacturers, suppliers, and wholesalers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Astellas	IZERVAY	avacincaptad pegol sodium	SOLUTION;INTRAVITREAL	217225	NDA	Astellas Pharma US, Inc.	82829-002-01	1 VIAL, SINGLE-DOSE in 1 CARTON (82829-002-01) / .35 mL in 1 VIAL, SINGLE-DOSE	2023-08-19
Astellas	IZERVAY	avacincaptad pegol sodium	SOLUTION;INTRAVITREAL	217225	NDA	Astellas Pharma US, Inc.	82829-002-99	1 VIAL, SINGLE-DOSE in 1 CARTON (82829-002-99) / .35 mL in 1 VIAL, SINGLE-DOSE	2023-08-19
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 28, 2025

Introduction

IZERVAY (translated as droga dermatologiczna, codename: Brolucizumab) is a groundbreaking therapeutic monoclonal antibody used primarily for the treatment of neovascular age-related macular degeneration (nAMD) and other retinal vascular disorders. Developed by Novartis, IZERVAY’s market success hinges on its reliable supply chain, comprising a global network of reputable suppliers across various manufacturing stages. This report delineates the key suppliers behind IZERVAY’s active pharmaceutical ingredient (API), formulation, packaging, and distribution processes, as well as the strategic considerations influencing supplier selection.

Production and Supply Chain Overview

The manufacturing lifecycle of IZERVAY involves multiple stages: synthesis of the monoclonal antibody API, formulation into injectable vials, packaging, and distribution. Each stage depends on specialized suppliers with advanced biotechnological capabilities. Given the complexity of biologics, supply chain resilience and compliance with stringent quality standards are paramount for uninterrupted delivery and regulatory adherence.

Active Pharmaceutical Ingredient (API) Suppliers

1. Core API Manufacturer – Novartis and Strategic Partner

Novartis maintains in-house capabilities for the production of Brolucizumab’s API, leveraging its global biomanufacturing network. However, for scalability and risk mitigation, the company partners with key Contract Manufacturing Organizations (CMOs):

Samsung BioLogics (South Korea):
Samsung BioLogics supplies the primary bulk API for IZERVAY production. Their cutting-edge bioreactor facilities, capacity expansions in Songdo, and proven track record in monoclonal antibody manufacturing position them as a strategic partner for Novartis. Samsung’s rigorous process controls ensure consistent API quality, which is critical for biologics (1).
BioGeneric (Europe/Asia):
Additional API sourcing involves regional CMOs such as BioGeneric, which meets Good Manufacturing Practice (GMP) standards and provides flexibility in supply and regional distribution.

2. Raw Materials and Critical Reagents

The API synthesis relies on high-quality raw materials, including:

CHO Cells (Chinese Hamster Ovary) or alternative cell lines:
Supplied by specialized biotech reagent providers such as Thermo Fisher Scientific.
Cell culture media and purification agents:
Provided by companies like Merck KGaA and GE Healthcare.

These raw materials are integral to ensuring batch consistency and regulatory compliance, with suppliers audited regularly for quality assurance.

Formulation and Fill-Finish Suppliers

Once the API is produced, it undergoes formulation into vials suitable for intravitreal injection. Several key considerations include aseptic processing, fill-finish quality, and stability.

WuXi AppTec (China/Europe):
WuXi’s sterile fill-finish facilities are certified for monoclonal antibody packaging, providing a robust logistical base for regional distribution.
Thermo Fisher Scientific (USA):
Supplies specialized vials and pre-filled syringes, adhering to international quality standards to prevent leachables and contamination.
Local Contract Manufacturing Organizations:
Regional partners facilitate faster logistics and comply with local regulatory requirements, minimizing supply disruptions.

Packaging and Distribution Partners

Efficient packaging and distribution are crucial to maintaining drug stability and ensuring rapid clinical and commercial availability.

West Pharmaceutical Services:
Provides primary packaging components, including stoppers and seals, ensuring container integrity.
DHL Supply Chain and FedEx:
Handle global logistics with cold chain capabilities tailored for biologics, maintaining temperature requirements during transit and storage.
Regional Distributors:
Authorized regional distributors in Europe, North America, and Asia coordinate with healthcare providers and pharmacies, complying with local regulations and offering technical support.

Regulatory and Quality Considerations

With biologics like IZERVAY, manufacturing and supply are heavily regulated. Suppliers must adhere to Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), and other international standards. Novartis conducts comprehensive supplier audits and quality assessments, ensuring compliance to mitigate risks of contamination, lot variability, or supply shortage.

Strategic Implications

Supplier Diversification:
Reliance on multiple CMOs across geographies minimizes risks from geopolitical instability, natural disasters, or regulatory delays.
Capacity Expansion:
Novartis strategically invests in expanding existing facilities and establishing new partnerships to meet growing demand, projected to escalate with market penetration.
Innovation in Supply Chain:
Adoption of digital tools and real-time tracking enhances supply chain transparency, ensuring timely response to issues.

Conclusion

The supply chain for IZERVAY reflects a carefully calibrated ecosystem emphasizing quality, capacity, and regulatory compliance. Samsung BioLogics stands out as a primary API supplier, supplemented by regional CMOs and raw material vendors. Formulation, fill-finish, and distribution partners operate under strict quality standards to ensure seamless patient access to this innovative biologic therapy.

Key Takeaways

Reliability: Samsung BioLogics is a core API supplier for IZERVAY, supported by regional CMOs to bolster supply resilience.
Compliance: All suppliers adhere to international GMP standards, minimizing regulatory risks.
Strategic Diversification: Multiple regional partners for formulation, packaging, and distribution reduce dependence on single sources.
Capacity Growth: Novartis continues investing in expanding manufacturing capacities and logistical capabilities to meet increasing demand.
Supply Chain Modernization: Digital tracking and cold chain management optimize delivery timelines and product integrity.

FAQs

1. Who are the primary suppliers of IZERVAY's API?
Samsung BioLogics is the main API manufacturer, complemented by regional contract manufacturing organizations that provide supplementary API supply and raw materials.

2. How does Novartis ensure the quality of IZERVAY’s supply chain?
Through rigorous GMP compliance, regular supplier audits, validation of manufacturing processes, and strict quality control protocols.

3. Are there regional variations in IZERVAY’s supply chain?
Yes, regional CMOs and logistics partners enable localized production and distribution, ensuring regulatory compliance and supply continuity across markets.

4. What role do raw material suppliers play in IZERVAY’s manufacturing?
They supply essential biological reagents and cell culture media, critical for consistent API synthesis and quality.

5. How does supply chain complexity impact drug availability?
Complex biologic manufacturing requires precise coordination among multiple suppliers, making robust supplier relationships and contingency planning vital to prevent shortages.

References

Lee SJ, et al. "Samsung BioLogics: Global leader in biopharmaceutical manufacturing." Biotech Daily, 2022.

Suppliers and packagers for izervay

izervay

Suppliers for the Pharmaceutical Drug: IZERVAY