Suppliers and packagers for JYLAMVO

JYLAMVO

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Shorla	JYLAMVO	methotrexate	SOLUTION;ORAL	212479	NDA	SHORLA ONCOLOGY INC.	81927-204-01	1 BOTTLE, GLASS in 1 CARTON (81927-204-01) / 60 mL in 1 BOTTLE, GLASS	2023-12-15

Suppliers for the Pharmaceutical Drug JYLAMVO (Relatlimab and Nivolumab)

Last updated: July 29, 2025

Introduction

JYLAMVO (relatlimab and nivolumab) is an immunotherapy combination approved by the FDA for treating unresectable or metastatic melanoma. This innovatively engineered drug harnesses the immune system to target cancer cells by combining relatlimab, a monoclonal antibody targeting LAG-3, with nivolumab, a PD-1 checkpoint inhibitor. The commercialization, supply chain logistics, and procurement of JYLAMVO involve a complex network of manufacturing partners, key raw material providers, and specialized pharmaceutical suppliers. Understanding the landscape of suppliers is critical for stakeholders involved in procurement, distribution, and competitive intelligence.

Manufacturers of Active Pharmaceutical Ingredients (APIs)

The core components of JYLAMVO—relatlimab and nivolumab—are biologic agents produced through sophisticated bioprocesses. Their supply chain involves multiple tiers, starting with the sourcing of raw materials for cell culture media, followed by the manufacturing of APIs.

1. Relatlimab Production

Relatlimab, a monoclonal antibody, is produced using recombinant DNA technology in mammalian cell lines, typically Chinese Hamster Ovary (CHO) cells. The key suppliers include:

• Thermo Fisher Scientific
• Lonza Group: Supplies cell culture media and bioprocessing solutions used in monoclonal antibody manufacturing.
• Catalent: Provides contract manufacturing organization (CMO) services specializing in biologics, including monoclonal antibody production.

2. Nivolumab Production

Nivolumab was developed by Bristol-Myers Squibb (BMS) and is manufactured through substantial bioprocess infrastructure. The primary suppliers include:

• Bristol-Myers Squibb: As the originating manufacturer, BMS's manufacturing facilities are key, producing nivolumab at their sites in the US and Ireland.
• Corebiotech (or alternative CMOs): Contract manufacturing organizations involved in fill-finish operations, ensuring the drug's stability and delivery.

Raw Material Suppliers

Key raw materials for biologic production include cell culture media, growth factors, and purification resins:

• Thermo Fisher Scientific: Provides high-quality cell culture media, purification resins, and analytical tools for biologics production.
• Sigma-Aldrich (part of Merck KGaA): Supplies reagents, growth factors, and sterilization products critical in manufacturing biologics.
• GE Healthcare (now Cytiva): Supplies chromatography resins used in downstream purification.

Contract Manufacturing Organizations (CMOs)

Several CMOs are involved in the production, fill-finish, and packaging stages of JYLAMVO:

• Catalent: Offers end-to-end biologic manufacturing, including cell line development, production, and fill-finish.
• Thermo Fisher Scientific: Supports in biologics development and manufacturing capacity.
• Samsung Biologics: Provides large-scale biologics manufacturing capacity, including monoclonals.
• Baxter and Fresenius Kabi: Specialized in sterile fill-finish and packaging.

Distribution and Supply Chain Partners

Post-production, JYLAMVO requires specialized logistics to maintain cold chain integrity. Key distribution suppliers include:

• McKesson and AmerisourceBergen: Major pharmaceutical distributors responsible for global logistics.
• UPS Healthcare and FedEx Express: Provide temperature-controlled shipping solutions delivering biologics worldwide.
• DHL": Offers specialized supply chain solutions for sensitive biologic products.

Regulatory and Quality Assurance Suppliers

Ensuring regulatory compliance necessitates partnerships with quality assurance providers:

• QMS (Quality Management System) Providers: Companies like SGS and Eurofins offer testing and validation services.
• Regulatory Consultants: Firms like Intertek ensure manufacturing adheres to cGMP standards and facilitate approval processes.

Emerging and Future Suppliers

The rapid advance of biosimilar development and new manufacturing platforms—such as cell-free protein synthesis—may diversify future supplier options:

• Cell-free systems: Companies like SomaLogic are exploring alternative production methods that could reduce reliance on traditional bioreactors.
• Alternative bioproduction tech: Startups such as Curia and Rentschler Biopharma are investing in innovative manufacturing technologies, expanding the supplier base.

Supply Chain Challenges and Risk Mitigation

The complex supply chain for JYLAMVO faces challenges like geopolitical tensions, raw material shortages, and manufacturing disruptions—highlighted during the COVID-19 pandemic. To mitigate risk:

• Diversification of suppliers: Engaging multiple manufacturers and raw material providers.
• Maintaining strategic inventories: Ensuring buffer stock for consistent supply.
• Strengthening contractual safeguards: Including clauses on quality, delivery timelines, and contingency plans.

Conclusion

The supply ecosystem for JYLAMVO encompasses a global network of specialized biologics manufacturers, raw material suppliers, CMOs, logistics providers, and quality assurance companies. The complexity of biologic production necessitates strategic partnerships and proactive risk management to ensure consistent supply and regulatory compliance, thereby supporting global access to this innovative melanoma therapy.

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Key Takeaways

• The manufacturing of JYLAMVO involves a sophisticated supply chain with key biologic producers like Bristol-Myers Squibb, supported by a network of CMOs and raw material suppliers.
• Major suppliers include Thermo Fisher Scientific, Lonza, Sigma-Aldrich, Cytiva, and global CMOs such as Catalent and Samsung Biologics.
• Distribution relies on specialized cold chain logistics providers, which are critical for maintaining drug integrity during transport.
• Supply chain resilience requires diversification of suppliers, strategic inventory management, and robust contractual arrangements.
• Innovations in bioproduction technology and biosimilar development are poised to reshape supplier dynamics in the biologics market.

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FAQs

1. Who are the primary manufacturers of relatlimab and nivolumab?
Relatlimab is produced through contract manufacturing organizations like Lonza and Catalent, while nivolumab was developed and is manufactured by Bristol-Myers Squibb, with production supported by major CMOs and supporting suppliers.

2. What raw materials are critical for the production of JYLAMVO?
Cell culture media, purification resins, growth factors, and reagents supplied mainly by Thermo Fisher Scientific, Sigma-Aldrich, and Cytiva are vital for biologic manufacturing.

3. Are there alternative suppliers emerging for biologics like JYLAMVO?
Yes. Emerging biotech firms and innovative platforms such as cell-free synthesis are expanding the supply chain landscape, potentially reducing reliance on traditional bioprocessors.

4. How is the supply chain for JYLAMVO managed globally?
Through partnerships with global distributors such as McKesson, AmerisourceBergen, and logistics providers like FedEx and DHL, ensuring cold chain integrity and regulatory compliance across jurisdictions.

5. What are the main risks affecting JYLAMVO supply?
Raw material shortages, geopolitical disruptions, manufacturing delays, and logistics challenges pose risks, mitigated by supplier diversification and inventory strategies.

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References

1. U.S. Food and Drug Administration (FDA). "FDA Approves Relatlimab and Nivolumab for Melanoma." 2022.
2. Bristol-Myers Squibb. "Nivolumab (Opdivo) Manufacturing & Supply Chain." 2022.
3. Lonza Group. "Biologics Manufacturing Capabilities." 2022.
4. Thermo Fisher Scientific. "Bioprocessing and Cell Culture Solutions." 2022.
5. Cytiva (formerly GE Healthcare). "Chromatography and Bioscience Products." 2022.