Suppliers and packagers for ofev

ofev

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Boehringer Ingelheim	OFEV	nintedanib esylate	CAPSULE;ORAL	205832	NDA	Boehringer Ingelheim Pharmaceuticals, Inc.	0597-0143-60	1 BOTTLE in 1 CARTON (0597-0143-60) / 60 CAPSULE in 1 BOTTLE	2014-10-15
Boehringer Ingelheim	OFEV	nintedanib esylate	CAPSULE;ORAL	205832	NDA	Boehringer Ingelheim Pharmaceuticals, Inc.	0597-0145-60	1 BOTTLE in 1 CARTON (0597-0145-60) / 60 CAPSULE in 1 BOTTLE	2014-10-15

Suppliers for the Pharmaceutical Drug: Ofev

Last updated: July 27, 2025

Introduction

Ofev, the brand name for the medication Xevudy (sotrovimab), is a monoclonal antibody used primarily for the treatment of COVID-19 in vulnerable populations. As a biologic product, its supply chain involves a complex network of manufacturing, logistics, and distribution channels governed by strict regulatory standards. This article explores the key suppliers involved in the production and distribution of Ofev, their roles, and the implications for stakeholders in the pharmaceutical supply chain.

Manufacturing of Sotrovimab (Ofev)

The production of Ofev hinges on sophisticated biotechnology processes that require specialized facilities and materials. The primary suppliers are involved in the upstream and downstream processes:

Bioreactor and Cell Culture Media Suppliers

Sotrovimab is produced via recombinant DNA technology using Chinese hamster ovary (CHO) cells. Critical to this process are bioreactors and cell culture media, sourced from specialized suppliers:

• Thermo Fisher Scientific: Provides bioreactors, media, and cell culture reagents used in biologics manufacturing. Their cell culture media, such as OpTmizer and InfiniTray systems, are integral for producing monoclonal antibodies like sotrovimab.
• GE Healthcare (Cytiva): Offers manufacturing equipment and media components compatible with large-scale biopharmaceutical production.
• Sartorius: Supplies filtration and bioprocessing equipment ensuring high-quality sterile environments necessary for biologic manufacturing.

Monoclonal Antibody Technology Suppliers

• GenScript: Provides gene synthesis and cloning services fundamental to producing the specific antibody sequences.
• Sigma-Aldrich (Merck): Supplies reagents and antibodies used for lab development and process validation stages.

Purification and Downstream Processing Suppliers

• Cytiva (formerly GE Healthcare): Supplies affinity chromatography resins such as Protein A, critical for antibody purification.
• Trisept Solutions: Offers viral clearance filters used during purification to ensure safety standards.

Raw Material and Active Pharmaceutical Ingredient (API) Suppliers

Unlike small molecule drugs, monoclonal antibodies are produced via living cell cultures; thus, the "raw materials" are biological reagents:

• Lonza: Supplies specialized cell banking and bioprocessing components.
• Molecular Assemblies: Provides proprietary expression vectors used in gene cloning of sotrovimab.
• Eppendorf: Supplies precision pipettes, tubes, and bioreactor accessories used throughout production.

Packaging and Auxiliary Material Suppliers

• Nexence: Produces sterile glass vials and rubber stoppers for final drug packaging.
• West Pharmaceutical Services: Supplies closure systems, stoppers, and syringe components critical for maintaining sterility during storage and transportation.

Distribution and Logistics

The distribution of Ofev relies on specialized logistics providers to preserve its thermal stability:

• DHL PharmaLife: Handles cold-chain logistics ensuring storage at required temperatures (-20°C to -80°C) during transit.
• FedEx Custom Critical: Provides expedited shipping solutions for urgent deliveries, especially during pandemic peaks.
• UPS Healthcare: Specializes in managing sensitive biologics, ensuring compliance with Good Distribution Practices (GDP).

Regulatory and Quality Assurance Suppliers

• IQVIA: Provides real-time market data and regulatory compliance services.
• Eurofins Scientific: Performs stability testing and batch release analysis, assuring quality before distribution.
• SGS: Conducts rigorous testing and certification of raw materials and final packaging.

Strategic Partnerships and Licensing

Major pharmaceutical companies involved in the licensing and distribution of Ofev include:

• GSK (GlaxoSmithKline): Licensed to manufacture and distribute sotrovimab, with a broad network of manufacturing and supply partners globally.
• Vir Biotechnology: Collaborated on development and supply agreements for sotrovimab.

Summary of Key Suppliers

Category	Leading Suppliers	Role
Bioreactors & Media	Thermo Fisher, GE Healthcare, Sartorius	Production of biologics
Cell Line Development	GenScript, Lonza	Cloning, cell banking
Purification	Cytiva, Trisept Solutions	Product purification
Raw Materials	Lonza, Eppendorf	Reagents and cell culture components
Packaging	Nexence, West Pharmaceutical	Final packaging materials
Logistics	DHL PharmaLife, FedEx, UPS	Temperature-controlled distribution
Regulatory Support	IQVIA, Eurofins, SGS	Quality assurance and testing

Implications for Stakeholders

The reliance on specialized suppliers makes the Ofev supply chain vulnerable to disruptions in the biotech sector, such as shortages of reagents or equipment delays. Strategic sourcing, diversification of suppliers, and regional manufacturing capacities are critical to maintaining a resilient supply.

Conclusion

The supply chain for Ofev is characterized by high complexity and a reliance on cutting-edge biotechnological suppliers, logistics providers, and quality assurance entities. Ensuring continuous, quality-controlled production requires a tightly coordinated network of global suppliers and logistical partners committed to stringent regulatory standards.

Key Takeaways

• The production of Ofev depends on specialized biotechnology suppliers providing cell culture media, reagents, and purification components.
• Disruptions in raw materials or manufacturing equipment can significantly impact Ofev availability.
• Leading logistics providers play a crucial role in maintaining cold chain integrity for global distribution.
• Diversifying supplier sources and expanding regional manufacturing can mitigate supply chain vulnerabilities.
• Ongoing quality assurance and regulatory compliance are essential to sustain supply and ensure patient safety.

FAQs

1. Who are the primary manufacturers of the active ingredient in Ofev?
Major manufacturing is conducted by licensed biotechnology firms like GlaxoSmithKline (GSK) and contracted contract manufacturing organizations (CMOs) specializing in monoclonal antibody production, supported by upstream suppliers such as Lonza and Thermo Fisher.

2. How do supply chain disruptions impact Ofev availability?
Any disruptions in the production of reagents, equipment shortages, or logistical challenges can delay manufacturing and distribution, particularly given the complex cold-chain requirements for biologics like Ofev.

3. Are there regional suppliers for Ofev’s raw materials?
While many raw materials are sourced globally, efforts are underway to increase regional manufacturing capacities, especially in Europe and Asia, to reduce dependency on single-source suppliers.

4. What measures exist to ensure the quality of Ofev during distribution?
Global logistics providers utilize validated cold-chain shipping solutions, temperature monitoring, and compliance with GDP standards to preserve drug integrity during transit.

5. How might future innovations impact the supply chain of monoclonal antibodies like Ofev?
Advances such as faster cell-line development, modular manufacturing platforms, and digital supply chain management are expected to enhance production scalability, reduce costs, and increase supply resilience.

---

References

1. [1] GSK's official product information for Ofev (sotrovimab), available at: https://gskpro.com
2. [2] Biopharmaceutical supply chain reports, Pharma Intelligence, 2022
3. [3] Regulatory guidelines for biologic manufacturing, FDA, EMA
4. [4] Cold chain logistics standards, DHL PharmaLife documentation, 2022
5. [5] Industry analysis on monoclonal antibody supply chain, IQVIA Reports, 2022