Suppliers and packagers for beleodaq

beleodaq

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Acrotech Biopharma	BELEODAQ	belinostat	POWDER;INTRAVENOUS	206256	NDA	Acrotech Biopharma Inc	72893-002-01	1 VIAL in 1 CARTON (72893-002-01) / 10 mL in 1 VIAL	2014-07-21

Suppliers for the Pharmaceutical Drug: BELEODAQ

Introduction
BELEODAQ (belantamab mafodotin-blmf) is an FDA-approved monoclonal antibody drug conjugate used primarily in the treatment of relapsed or refractory multiple myeloma. Developed by GlaxoSmithKline (GSK), BELEODAQ signifies a groundbreaking advancement in targeted cancer therapy, leveraging antibody-drug conjugates to deliver cytotoxic agents directly to cancer cells. As an important therapeutic asset, understanding its suppliers—from raw material providers to manufacturing partners—is critical for stakeholders seeking supply chain resilience, compliance, and competitive advantage.

Manufacturing Origins and GSK’s Role
GSK operates as the sole marketing and manufacturing entity for BELEODAQ, relying on an extensive network of suppliers for the complex components involved in its production. The drug comprises several critical elements: the monoclonal antibody, the linker, and the cytotoxic payload (monomethyl auristatin F, MMAF). The production of each component involves specialized suppliers with expertise in biologics, chemistry, and industrial-scale conjugation processes.

Raw Material Suppliers for Belantamab Mafodotin

1. Monoclonal Antibody Production

The foundation of BELEODAQ is the monoclonal antibody (mAb) targeting B-cell maturation antigen (BCMA). GSK sources the cell lines and bioreactor systems used to produce this mAb from leading biologics contract manufacturing organizations (CMOs).

• Contract Manufacturing Organizations (CMOs):
  • Samsung Biologics: A prominent CMO with capacity for large-scale biologic production, Samsung supplies recombinant DNA-derived monoclonal antibodies to GSK for BELEODAQ. Their advanced bioreactor facilities ensure high purity and batch consistency.
  • BoHui Biotech: Known for specialized antibody synthesis, BoHui supports early-stage manufacturing and scale-up activities.
  • Lonza: While primarily involved in upstream cell culture processes and biosynthesis for other labs, Lonza's contract services extend to antibody generation for biologic drugs.

2. Cytotoxic Payload (MMAF)

MMAF, a synthetic auristatin derivative, is crucial for the cytotoxic action of BELEODAQ. Its synthesis involves complex chemical processes requiring high purity and stringent quality controls.

• MMAF Raw Material Suppliers:
  • Sigma-Aldrich (Merck): Supplies high-grade MMAF with certifications complying with GMP standards.
  • ChemPartner and ChemBridge: Smaller specialty chemical suppliers providing intermediates and precursors for MMAF synthesis.
  • Tianjin Interbio Pharmaceutical Co., Ltd.: A Chinese manufacturer that supplies GMP-grade MMAF used in antibody-drug conjugates globally.

3. Linker and Conjugation Components

The linker attaches MMAF to the antibody, stability, and control release of the cytotoxic agent. The precise chemistry of the linker is proprietary, but process ingredients are sourced from specialized chemical suppliers.

• Chemical Suppliers for Linkers and Linker-Payload Conjugates:
  • Cytel (a contract research organization): Provides custom linker synthesis under GMP conditions.
  • Ablze Pharmaceuticals: Supplies linker molecules optimized for conjugation efficiency and stability.

Manufacturing Partners and Supply Chain
While GSK maintains direct control over final drug manufacturing, it relies heavily on contract manufacturing organizations for intermediate production stages, quality testing, and final formulation.

4. Contract Manufacturing and Fill-Finish Operations

BELEODAQ’s complex manufacturing process involves conjugation, purification, sterile filling, and packaging, often outsourced to CMOs with specialized capabilities.

• CMO Partners for Manufacturing and Packaging:
  • Samsung Biologics: Handles bulk biologic production and conjugation.
  • Thermo Fisher Scientific (formerly Patheon): Provides fill-finish services for biologics, ensuring sterility and compliance with pharmaceutical standards.
  • BioVectra: Supplies conjugation services, ensuring stability and potency of the antibody-drug conjugate during production.

Distribution and Logistics
Distribution relies on GSK’s global logistics partners, including DHL and FedEx, utilizing temperature-controlled supply chain systems to maintain cold chain integrity, especially crucial for biologics like BELEODAQ.

Regulatory and Compliance Considerations
GSK ensures all suppliers meet stringent quality standards, including compliance with GMP (Good Manufacturing Practice), ICH guidelines, and regional regulatory requirements. Suppliers are subject to audits and validation processes before approval.

Emerging Trends and Supply Chain Dynamics

1. Diversification of Supplies

In response to global supply chain disruptions—exacerbated by the COVID-19 pandemic—GSK and other pharmaceutical companies have diversified their supplier base for key raw materials, including MMAF and antibody components. This strategy reduces dependency on single vendors and enhances resilience.

2. Advances in Biologics Manufacturing

The increased adoption of single-use bioreactors and continuous manufacturing methods has transformed biologic drug supply chains, enabling faster scale-up and more flexible sourcing. Suppliers like Samsung Biologics have led these innovations.

3. Focus on Sustainability and Supply Security

Sustainability initiatives aim to reduce environmental impact, with suppliers investing in greener chemical processes and renewable energy sources. Supply security now emphasizes geographic diversification and strategic stockpiling.

Regulatory and Supply Chain Risks
Potential risks include raw material shortages, geopolitical issues affecting Chinese and Asian suppliers, and quality non-compliance. GSK mitigates these through supplier qualification programs, regional manufacturing hubs, and contingency planning.

Key Takeaways

• GSK relies on a global network of specialized suppliers for BELEODAQ’s components, notably CMOs like Samsung Biologics for biologic production and chemical suppliers for MMAF and linkers.
• The supply chain’s complexity necessitates rigorous quality assurance, regulatory compliance, and diversification strategies to ensure uninterrupted access.
• Advances in bioprocessing and manufacturing technologies facilitate faster scale-up, but geopolitical and logistical risks require ongoing management.
• The proprietary nature of the linker and conjugation chemistry underscores the importance of maintaining trusted supplier relationships and safeguarding intellectual property.
• Strategic sourcing and supply chain transparency are critical as demand for antibody-drug conjugates continues to grow globally.

FAQs

Last updated: July 29, 2025

1. Who are the primary raw material suppliers for BELEODAQ?
GSK sources the monoclonal antibody components from CMOs such as Samsung Biologics and cell line providers, while chemical precursors like MMAF are supplied by companies including Sigma-Aldrich and Tianjin Interbio Pharmaceutical.

2. How does GSK ensure the quality of its suppliers for BELEODAQ?
GSK conducts rigorous qualification processes, including audits, certifications (GMP compliance), and ongoing supplier performance evaluations aligned with regulatory standards such as FDA and EMA.

3. Are there alternative suppliers for the key components of BELEODAQ?
Yes, GSK actively diversifies its supplier base to mitigate risks associated with supply disruptions, sourcing components from multiple qualified vendors globally.

4. How does supply chain complexity impact the availability of BELEODAQ?
The complexity, especially in biologic manufacturing and conjugation steps, heightens vulnerabilities to disruptions. Strategic partnerships, diversified sourcing, and advanced manufacturing practices help ensure consistent supply.

5. What future trends might influence suppliers for BELEODAQ?
Increasing adoption of continuous biomanufacturing, emphasis on sustainability, and geopolitical shifts will likely shape supplier relationships and sourcing strategies further.

Sources
[1] GSK official product information and press releases.
[2] Industry reports on biologics manufacturing and supply chain management.
[3] Contract manufacturing organizations’ public disclosures.
[4] Pharmacopoeia and GMP guidelines.
[5] Market analyses of antibody-drug conjugate supply chains.