WELIREG: Pharmaceutical manufacturers, suppliers, and wholesalers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Merck Sharp Dohme	WELIREG	belzutifan	TABLET;ORAL	215383	NDA	Merck Sharp & Dohme LLC	0006-5331-01	90 TABLET, FILM COATED in 1 BOTTLE (0006-5331-01)	2021-08-13
Merck Sharp Dohme	WELIREG	belzutifan	TABLET;ORAL	215383	NDA	Merck Sharp & Dohme LLC	0006-5331-58	1 BOTTLE in 1 CARTON (0006-5331-58) / 90 TABLET, FILM COATED in 1 BOTTLE	2021-08-13
Merck Sharp Dohme	WELIREG	belzutifan	TABLET;ORAL	215383	NDA	Merck Sharp & Dohme LLC	0006-5331-59	1 BOTTLE in 1 CARTON (0006-5331-59) / 90 TABLET, FILM COATED in 1 BOTTLE	2021-08-13
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 30, 2025

Introduction

WELIREG (belantamab mafodotin-blmf) is a novel therapeutic agent approved by the U.S. Food and Drug Administration (FDA) in 2020 for the treatment of relapsed or refractory multiple myeloma. As a targeted anti-cancer drug, its manufacturing involves complex bio-synthesis processes and sophisticated supply chain management. For healthcare providers, distributors, and investors, understanding the key suppliers involved in WELIREG’s production is critical to ensuring drug availability, maintaining quality standards, and mitigating supply chain risks.

Manufacturing and Supply Chain Overview

WELIREG is a monoclonal antibody-drug conjugate (ADC), combining a monoclonal antibody targeting BCMA (B-cell maturation antigen) with a cytotoxic agent, mafodotin. Developing a drug of this complexity involves multiple tiers of suppliers:

Raw Material Suppliers (biological and chemical components)
Manufacturing Partners (biologic and chemical synthesis, conjugation)
Packaging Suppliers
Distribution Networks

Understanding each tier provides clarity on the security and robustness of the WELIREG supply chain.

Key Suppliers Involved in WELIREG Production

1. Raw Material Suppliers

a. Monoclonal Antibody Production

The core component of WELIREG is its monoclonal antibody targeting BCMA. This antibody is produced using Chinese hamster ovary (CHO) cell lines, which require high-grade biological raw materials.

Lonza Group: A leading supplier of cell culture media, fed-batch bioreactors, and recombinant biological raw materials used in antibody manufacturing ([1]). Lonza provides critical components used by biopharmaceutical companies for antibody expression.
Thermo Fisher Scientific: Supplies cell culture media, sera, and reagents essential for monoclonal antibody production ([2]).

b. Cytotoxic Payload (Mafodotin)

Mafodotin, the cytotoxic component, is a microtubule-targeting agent conjugated to the antibody.

ImClone Systems (a Lilly subsidiary): Produces the cytotoxic warhead used in ADCs, including MMAF derivatives ([3]).
Others: Specialized chemical suppliers providing intermediate compounds and conjugation linkers.

2. Conjugation and Final Drug Manufacturing

Seagen Inc. (formerly Seattle Genetics): Licensed and supplies technologies related to ADC synthesis, conjugation, and purification processes ([4]).
Contract Manufacturing Organizations (CMOs)
- Fujifilm Diosynth Biotechnologies: Likely involved in producing biologics at scale under licensing agreements ([5]).
- Boehringer Ingelheim: Known for contract manufacturing of complex biologics, possibly involved in late-stage production or filling.

3. Packaging Materials

Nipro Corporation: Supplies sterile vials and stoppers designed for biologics.
West Pharmaceutical Services: Provides advanced pre-fillable syringes and packaging components adhering to strict sterility requirements.

4. Distribution and Logistics Partners

McKesson Corporation and CVS Health: Major pharmaceutical distributors facilitating global reach.
Fresenius Kabi: Manages cold chain logistics for biologics, ensuring stability during transit ([6]).

Regulatory and Quality Considerations

Given the complex nature of ADCs like WELIREG, all suppliers must meet stringent quality standards such as Good Manufacturing Practice (GMP) compliance, validated by regulatory agencies worldwide. The supply chain is regularly audited to ensure consistency, safety, and efficacy.

Emerging Trends in WELIREG Supply Chain

Diversification of Raw Material Sources: To mitigate risk, manufacturers are expanding supplier networks.
Supply Chain Digitization: Enhanced tracking, traceability, and quality assurance via digital platforms.
Localized Manufacturing: Increasing regional manufacturing hubs to reduce lead times and transportation costs.

Challenges and Risks

Supply Disruption Risks: Dependency on specialized raw materials from limited suppliers exposes the supply chain to vulnerabilities.
Regulatory Changes: Stringent international standards influence supplier qualification and manufacturing practices.
Market Demand Fluctuations: Rapid growth in demand can strain production capacities.

Key Takeaways

WELIREG’s production relies on a multi-tiered supplier network, including raw material providers such as Lonza and Thermo Fisher Scientific, and contract manufacturers like Fujifilm Diosynth Biotechnologies.
The intricate conjugation process emphasizes the importance of specialized CMOs with expertise in ADC manufacturing, highlighting the need for continuous supplier evaluation.
Packaging and logistics providers ensure the integrity and timely delivery of WELIREG, critical for maintaining drug stability and patient safety.
Supply chain resilience depends on diversification, digital tracking, and regional manufacturing hubs. Companies must proactively manage regulatory compliance and quality assurance.
Investors and stakeholders should monitor supplier relationships and global production capacity to anticipate supply constraints or disruptions.

FAQs

1. Who are the primary manufacturers behind WELIREG's active components?
The monoclonal antibody is produced via biotechnological processes involving suppliers like Lonza and Thermo Fisher Scientific. The cytotoxic payload Mafodotin is supplied by specialized companies such as ImClone Systems, a Lilly subsidiary.

2. What role do contract manufacturing organizations play in WELIREG’s production?
CMOs like Fujifilm Diosynthetis and Boehringer Ingelheim handle complex biologic conjugation, purification, and formulation processes, ensuring high-quality production at scale.

3. How does supply chain robustness impact WELIREG’s availability?
A resilient supply chain, characterized by diversified suppliers and regional production, ensures continuous availability, mitigates risks from geopolitical or logistical disruptions, and maintains consistent drug quality.

4. Are there challenges related to raw material sourcing for WELIREG?
Yes. The specialized biological and chemical inputs are limited to few suppliers, creating potential vulnerabilities. Diversification and strategic stockpiling are strategies employed to counteract these risks.

5. How do regulatory standards influence WELIREG supply chain management?
Strict adherence to GMP standards and ongoing audits ensure supplier compliance with safety, efficacy, and quality benchmarks, which are vital for licensed production and market approval.

References

[1] Lonza Group. Biologics Manufacturing Solutions. Retrieved from https://www.lonza.com.

[2] Thermo Fisher Scientific. Biological Reagents and Cell Culture Media. Retrieved from https://www.thermofisher.com.

[3] ImClone Systems. Cytotoxic Payload Development. Lilly Corporate Website. Retrieved from https://www.lilly.com.

[4] Seattle Genetics (Seagen). ADC Technology and Licensing. Retrieved from https://www.seattlegenetics.com.

[5] Fujifilm Diosynth Biotechnologies. Contract Development & Manufacturing. Retrieved from https://fujifilmhcp.com.

[6] Fresenius Kabi. Cold Chain Logistics for Biologics. Retrieved from https://www.fresenius-kabi.com.

End of Article

Suppliers and packagers for WELIREG

WELIREG

Suppliers for the Pharmaceutical Drug: WELIREG