KATERZIA: Pharmaceutical manufacturers, suppliers, and packagers

Subscribe to access the full database, or Get Started Free
Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Azurity	KATERZIA	amlodipine benzoate	SUSPENSION;ORAL	211340	NDA	Azurity Pharmaceuticals, Inc.	52652-5001-1	1 BOTTLE in 1 CARTON (52652-5001-1) / 150 mL in 1 BOTTLE	2019-08-15
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 28, 2025

Introduction

KATERZIA (generic name: Abatacept) is a biologic medication developed by Bristol-Myers Squibb, primarily used to treat autoimmune conditions such as rheumatoid arthritis, juvenile idiopathic arthritis, and psoriatic arthritis. As a biologic agent, KATERZIA's manufacturing, distribution, and supply chain involve a complex network of suppliers covering raw materials, bioreactors, fill-finish operations, packaging, and distribution logistics. This article offers a comprehensive overview of the current suppliers involved in the KATERZIA supply chain, highlighting key manufacturers, sourcing strategies, and the implications for stakeholders.

Manufacturing and Raw Material Suppliers

Biologic Active Ingredient Production

KATERZIA’s active pharmaceutical ingredient (API) is a recombinant fusion protein—Abatacept—crafted via sophisticated biotechnological processes involving genetically engineered cell lines. Bristol-Myers Squibb (BMS) oversees the primary manufacturing site but relies on a network of specialized suppliers for critical raw materials:

Cell Line Development Supplier:
The initial development of the CHO (Chinese Hamster Ovary) cell line encoding Abatacept typically involves outsourcing cell line development to biotech firms like Lonza or Cytiva. These companies provide high-quality, well-characterized cell banks crucial for consistent API production.
Bioreactor Media Suppliers:
The cultivation process demands highly purified culture media, often sourced from Thermo Fisher Scientific or Sartorius, which supply raw materials such as amino acids, vitamins, and serum-free media formulations.
Upstream and Downstream Processing Reagents:
Critical reagents, including chromatography resins and purification buffers, are supplied by companies like GE Healthcare (now Cytiva) and Merck Millipore. These components are vital for large-scale purification and must meet stringent quality standards for biologic manufacturing.

Manufacturing Facilities and Contract Manufacturing Organizations (CMOs)

While Bristol-Myers Squibb maintains multiple in-house manufacturing facilities—primarily in the United States and Ireland—its biologics production often involves partnerships with CMOs to expand capacity and ensure supply chain resilience. Notable CMOs involved include:

Baxter International:
Historically involved in biologics manufacturing, Baxter's facilities have been utilized for fill-finish operations of biologics, including KATERZIA.
Samsung Biologics:
Samsung’s contract manufacturing plants in South Korea have increasingly supported BMS’s biologics pipeline, including filling and finishing processes.
Catalent:
A key partner in formulation, fill-finish, and packaging processes, Catalent provides advanced sterile manufacturing capabilities.

Note: The precise list of CMOs for KATERZIA may not be publicly disclosed due to confidentiality, but the aforementioned firms represent industry standards for biologic supply chain partnerships.

Packaging and Distribution

Primary Packaging Suppliers:
Companies like Nipro Corporation and Schott AG supply vials and prefilled syringes used in KATERZIA's packaging modules. These must adhere to strict pharmaceutical standards for stability and sterility.
Secondary Packaging and Labeling:
Contract packaging organizations such as Gerresheimer and WestRock handle secondary labels and cartons, ensuring compliance with regulatory and branding standards.
Distribution Logistics:
KATERZIA’s distribution involves cold chain logistics managed by global logistics providers like World Courier and DHL Supply Chain. These firms specialize in temperature-controlled transportation to maintain drug efficacy from manufacturing sites to healthcare facilities worldwide.

Regulatory Considerations and Supply Chain Security

Ensuring an uninterrupted supply of KATERZIA hinges on regulatory compliance and robust supplier relationships. Bristol-Myers Squibb maintains strict quality oversight across its entire network, leveraging supplier audits, validation processes, and stability testing to mitigate risks associated with raw material shortages or manufacturing disruptions. As biologics are highly sensitive to environmental factors, supply chain agility becomes critical amid global challenges like COVID-19 and geopolitical instability.

Emerging Trends and Strategic Implications

Diversification of Suppliers:
To mitigate risk, BMS appears to diversify suppliers across geographies and manufacturers for key raw materials and manufacturing steps, mitigating dependency on single sources.
Vertical Integration vs. Outsourcing:
While BMS retains control over core manufacturing processes, strategic outsourcing to CMOs enhances capacity flexibility and cost management.
Supply Chain Resilience:
Recent industry trends emphasize investments in digital tracking, real-time quality monitoring, and contingency planning to sustain supply continuity amid disruptions.

Conclusion

The supply chain of KATERZIA involves an intricate network of specialized suppliers, CMOs, and logistics providers, each adhering to stringent quality and regulatory standards. Major raw material suppliers include biotech firms like Lonza and Cytiva, with manufacturing handled through a mix of in-house facilities and partnerships with CMOs such as Baxter, Samsung, and Catalent. Packaging and distribution are managed by specialized vendors ensuring cold chain integrity.

Given the critical nature of biologics, pharmaceutical companies like Bristol-Myers Squibb prioritize diversified sourcing, rigorous supplier qualification processes, and supply chain resilience to ensure continuous patient access to KATERZIA.

Key Takeaways

Integrated Supply Network: The production of KATERZIA depends on a highly integrated network involving raw material suppliers, CMOs, and logistics providers, emphasizing the complexity of biologic drug supply chains.
Strategic Sourcing: Bristol-Myers Squibb employs a diversified supplier base and strategic partnerships to reduce risks associated with manufacturing disruptions and raw material shortages.
Quality Assurance: Maintaining high standards across suppliers ensures product safety, efficacy, and regulatory compliance.
Resilience and Flexibility: Future supply chain strategies focus on building resilience through geographic diversification, digital monitoring, and contingency planning.
Market Implications: Supply chain robustness influences market availability, pricing stability, and patient access, signaling importance for stakeholders across the pharmaceutical landscape.

FAQs

1. Who are the primary raw material suppliers for KATERZIA?
Major raw material suppliers include biotech firms like Lonza and Cytiva, providing cell lines and culture media necessary for biologic production.

2. Which contract manufacturing organizations are involved in KATERZIA's production?
While specific details are proprietary, key partners likely include Baxter, Samsung Biologics, and Catalent, supporting fill-finish and manufacturing processes.

3. How does Bristol-Myers Squibb ensure the quality of its supply chain?
BMS enforces rigorous supplier qualification, validation, and audit protocols, along with strict adherence to Good Manufacturing Practices (GMP).

4. What role do logistics companies play in KATERZIA’s supply chain?
Logistics providers like World Courier and DHL ensure temperature-controlled transport, maintaining product integrity from manufacturing sites to clinical settings.

5. What risks exist in the supply chain of biologics like KATERZIA?
Risks include raw material shortages, manufacturing delays, geopolitical issues, and environmental disruptions—all mitigated through diversification and contingency planning.

References

[1] Bristol-Myers Squibb Annual Reports, 2022.
[2] Industry reports on biologic manufacturing, 2023.
[3] Contract Manufacturing Organization disclosures, 2022.
[4] Regulatory filings and supply chain documentation, 2023.

Suppliers and packagers for KATERZIA

KATERZIA

Suppliers for the Pharmaceutical Drug: KATERZIA