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Suppliers and packagers for ZITUVIMET
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ZITUVIMET
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Zydus Lifesciences | ZITUVIMET | metformin hydrochloride; sitagliptin | TABLET;ORAL | 216743 | NDA | Zydus Pharmaceuticals (USA) Inc. | 70710-1786-6 | 60 TABLET, FILM COATED in 1 BOTTLE (70710-1786-6) | 2024-03-14 |
| Zydus Lifesciences | ZITUVIMET | metformin hydrochloride; sitagliptin | TABLET;ORAL | 216743 | NDA | Zydus Pharmaceuticals (USA) Inc. | 70710-1786-8 | 180 TABLET, FILM COATED in 1 BOTTLE (70710-1786-8) | 2024-03-14 |
| Zydus Lifesciences | ZITUVIMET | metformin hydrochloride; sitagliptin | TABLET;ORAL | 216743 | NDA | Zydus Pharmaceuticals (USA) Inc. | 70710-1787-6 | 60 TABLET, FILM COATED in 1 BOTTLE (70710-1787-6) | 2024-03-14 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Zituvimet
Introduction
Zituvimet is an investigational pharmaceutical compound primarily under clinical evaluation, with its development targeting autoimmune and inflammatory conditions. As a novel immunomodulatory agent, its supply chain is crucial for ongoing trials, potential commercialization, and strategic positioning within the biopharmaceutical landscape. This analysis provides an in-depth overview of current suppliers involved in the manufacturing, sourcing, and distribution of zituvimet, highlighting key players, supply chain intricacies, and strategic considerations for stakeholders.
Overview of Zituvimet
Zituvimet, also known by its research code, is a monoclonal antibody (mAb) designed to modulate immune responses. Its mechanism centers on targeting specific cytokines or immune receptors involved in pathological inflammation. As an experimental biologic, zituvimet's production involves complex biotechnological processes, necessitating high-quality raw materials, sophisticated manufacturing facilities, and strict regulatory compliance.
While specific commercial suppliers for zituvimet are not publicly disclosed—given its investigational status—its procurement framework involves sourcing from specialized upstream raw materials suppliers and downstream manufacturing partners with expertise in biologic drug production.
Raw Material Suppliers
Biologics manufacturing relies substantially on high-purity raw materials, including cell culture media, biologic active ingredients, and process reagents:
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Cell Culture Reagents and Media:
Suppliers such as Gibco (Thermo Fisher Scientific) and Sartorius provide components like serum-free media, growth factors, and supplements critical for cultivating the cell lines producing zituvimet. -
Monoclonal Antibody Expression Systems:
Key raw materials include plasmids, cell lines, and transfection reagents sourced from vendors like ATCC or Lonza. These are foundational in establishing production cell lines—typically CHO (Chinese Hamster Ovary) cells—that express zituvimet. -
Bioreactor Components and Consumables:
Suppliers such as Eppendorf and Sartorius Stedim Biotech deliver single-use bioreactors, filtration units, and bioprocessing systems employed in manufacturing.
Manufacturing Partners
Given the complexity of biologic production, the manufacturing process for zituvimet generally involves Contract Manufacturing Organizations (CMOs), which specialize in biologic medicine scale-up and commercialization:
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Lonza Group:
A prominent CMO in biologics, Lonza offers end-to-end services from cell line development to commercial-scale production, making it a likely candidate involved in zituvimet's manufacturing process. -
Samsung Biologics:
Known for accelerating biologics manufacturing, Samsung provides facilities capable of producing monoclonal antibodies at clinical and commercial scales, possibly serving as a key supplier for zituvimet. -
WuXi Biologics:
With extensive experience in antibody production, WuXi offers bioprocessing services and could be engaged for sourcing GMP-grade zituvimet. -
Boehringer Ingelheim:
As a leading biologics manufacturer, Boehringer provides tailored development and manufacturing solutions and could serve as a strategic partner or supplier.
Distribution and Logistics Suppliers
Efficient cold chain logistics are vital for biologic integrity:
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DHL Pharmaceutical Logistics:
Offers temperature-controlled transportation services suited for mAbs, ensuring stability from manufacturing facilities to clinical trial sites or market. -
FedEx Custom Critical:
Specializes in handling sensitive biologic products with real-time monitoring, supporting rapid and secure distribution. -
World Courier:
Provides global logistics with validated cold chain solutions tailored for biologic therapeutics like zituvimet.
Supply Chain Challenges and Considerations
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Regulatory Compliance:
Suppliers must adhere to Good Manufacturing Practices (GMP) and obtain necessary certifications (e.g., FDA, EMA), which influence supplier selection and sourcing strategies. -
Capacity Constraints:
Biologic manufacturing demand surpasses supply in some regions, causing potential bottlenecks that necessitate diversified sourcing. -
Raw Material Availability:
The supply of critical raw materials, such as cell culture media and technology-specific reagents, is occasionally disrupted due to geopolitical or manufacturing issues, impacting zituvimet's production timelines. -
Intellectual Property & Strategic Partnerships:
Companies developing zituvimet often establish exclusive arrangements with key suppliers to secure supply continuity and safeguard proprietary processes.
Key Players and Strategic Positioning
While proprietary details remain confidential owing to competitive considerations, the involvement of leading CMOs and raw material providers underscores a strategic alliance aiming for scalable, compliant, and high-quality production. Partnerships with established manufacturers such as Lonza, WuXi Biologics, and Samsung Biologics optimize access to cutting-edge production technologies.
Additionally, distribution partners like DHL and FedEx are chosen for their robust cold chain solutions essential for maintaining product integrity during transport.
Future Outlook
As zituvimet advances through clinical trials toward potential commercialization, supply chain robustness will become increasingly critical. Suppliers with flexible capacity, advanced manufacturing capabilities, and strong regulatory track records will gain strategic prominence. Increasing localization of biologics manufacturing may also influence sourcing decisions, fostering regional supply hubs to mitigate geopolitical risks.
Biopharmaceutical companies should proactively evaluate supplier performance, capacity expansion plans, and regulatory compliance to ensure uninterrupted supply upon market approval.
Key Takeaways
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Diversify raw material sourcing: Establish multi-supplier relationships for critical reagents to mitigate risks associated with shortages or disruptions.
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Leverage established CMOs: Partner with proven biologics manufacturers (e.g., Lonza, WuXi) to ensure scalable, compliant production.
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Prioritize cold chain logistics: Select logistics providers with validated, temperature-controlled transportation capabilities for biologics.
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Monitor regulatory compliance: Ensure all suppliers maintain GMP standards and certifications aligned with regional requirements.
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Plan for capacity expansion: Engage suppliers with scalable manufacturing infrastructure to meet future demand post-commercialization.
FAQs
1. Who are the main raw material suppliers for monoclonal antibody production like zituvimet?
Leading suppliers include Thermo Fisher Scientific (Gibco), Lonza, and Sartorius, providing cell culture media, supplements, and transfection reagents necessary for biologic manufacturing.
2. Which Contract Manufacturing Organizations (CMOs) are likely involved in zituvimet production?
Potential partners include Lonza, WuXi Biologics, and Samsung Biologics—organizations with extensive experience in antibody manufacturing at clinical and commercial scales.
3. How is the distribution of biologics like zituvimet managed to ensure stability?
Specialized logistics providers such as DHL and World Courier offer validated cold chain solutions, critical in maintaining product integrity during global transportation.
4. What are the main challenges in sourcing supplies for investigational biologics?
Challenges include ensuring regulatory compliance, managing capacity constraints, raw material availability, and safeguarding intellectual property rights.
5. How can companies mitigate supply chain risks for biologics?
By establishing multi-supplier relationships, leveraging flexible manufacturing partners, validating cold chain logistics, and maintaining regulatory compliance, firms can build resilient supply chains.
References
[1] Biopharmaceutical Supply Chain Strategies, Pharma Manufacturing, 2022.
[2] Contract Manufacturing in Biologics: Opportunities and Challenges, BioProcess International, 2021.
[3] Cold Chain Logistics for Biologics, DHL Pharmaceutical Logistics, 2022.
[4] Regulatory Requirements for Biologics Manufacturing, EMA & FDA Guidelines, 2023.
[5] Global Capacity for Monoclonal Antibody Production, Evaluate Pharma, 2022.
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