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Suppliers and packagers for QUZYTTIR
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QUZYTTIR
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Jdp | QUZYTTIR | cetirizine hydrochloride | SOLUTION;INTRAVENOUS | 211415 | NDA | TerSera Therapeutics LLC | 70720-100-10 | 1 VIAL, GLASS in 1 CARTON (70720-100-10) / 1 mL in 1 VIAL, GLASS (70720-100-01) | 2019-11-13 |
| Jdp | QUZYTTIR | cetirizine hydrochloride | SOLUTION;INTRAVENOUS | 211415 | NDA | TerSera Therapeutics LLC | 70720-100-25 | 25 VIAL, GLASS in 1 CARTON (70720-100-25) / 1 mL in 1 VIAL, GLASS (70720-100-01) | 2019-11-13 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Quzyttir
Introduction
The pharmaceutical landscape is highly dynamic, with a reliance on diverse suppliers to ensure the availability and affordability of medications. Quzyttir, an FDA-approved medication primarily used for the treatment of hereditary angioedema (HAE), exemplifies this complex supply chain. As a biologic drug with a specialized manufacturing process, Quzyttir's suppliers are critical to maintaining efficacy, safety, and supply stability. This article examines the key suppliers involved in the production and distribution of Quzyttir, highlighting their roles, strategic importance, and the implications for stakeholders.
Overview of Quzyttir
Quzyttir is the brand name for ecallantide, a recombinant protein drug developed by Dyax Corp (later acquired by AbbVie). It functions as a kallikrein inhibitor to prevent angioedema episodes in patients with HAE. Given its biologic nature, Quzyttir's manufacturing involves sophisticated biotechnological processes, including cell culture, protein expression, purification, and formulation.
Manufacturing Suppliers for Quzyttir
1. BioLogics and Cell Line Development
The foundation of Quzyttir's supply chain begins with cell line development. Unique proprietary cell lines, often derived from Chinese Hamster Ovary (CHO) cells, are essential for recombinant protein expression. The key suppliers in this domain include:
- Thermo Fisher Scientific: Provides critical reagents, media, and tools for cell culture systems and line development.
- MilliporeSigma (Merck KGaA): Supplies CHO cell lines, vectors, and genetic modification tools necessary for stable cell line creation.
2. Bioreactor and Upstream Production Equipment
Large-scale manufacturing relies on specialized bioreactors capable of producing consistent and pure biologic drugs:
- Eppendorf and Sartorius Stedim Biotech supply stirred-tank bioreactors, single-use bioreactors, and bioprocessing solutions optimized for monoclonal antibodies and recombinant proteins like ecallantide.
3. Raw Materials and Reagents
High-purity raw materials are vital for ensuring the integrity of the final biologic:
- GE Healthcare (now part of Cytiva): Supplies chromatography media, filtration systems, and purification reagents.
- Lonza: Offers fermentation media and cell culture supplements essential for high-yield protein expression.
4. Purification and Formulation
Following upstream processing, the protein undergoes purification and formulation:
- GE Healthcare / Cytiva: Provides chromatographic columns, filtration membranes, and formulation buffers.
- Pall Corporation: Supplies sterile filtration systems critical for ensuring the final product's safety.
5. Fill-Finish and Packaging
The final drug dose involves aseptic filling and packaging:
- Becton Dickinson (BD) and Joerns Healthcare: Offer sterile, single-use filling lines specialized for biologics.
- Schott AG: Supplies vials and stoppers used in the final packaging stage.
Supply Chain Consolidation and Strategic Partnerships
Given the complexity and sensitivity of biologic manufacturing, companies like AbbVie often engage in strategic partnerships with contract manufacturing organizations (CMOs) to diversify supply sources and mitigate risks. Notable CMOs involved with biologics include:
- Fujifilm Diosynth Biotechnologies: Provides GMP manufacturing capabilities for biologic drugs, including upstream and downstream processes.
- Samsung Biologics: Offers large-scale manufacturing and fill-finish capacities, supporting supply stability and scalability.
Regulatory and Quality Considerations
Suppliers must meet stringent quality standards aligned with Good Manufacturing Practices (GMP). Regulatory agencies, including the FDA and EMA, require meticulous documentation and validation of all materials and processes used in production.
Impact of Supplier Reliability on Supply Stability
The specialized nature of Quzyttir's supply chain means that disruptions — whether from raw material shortages, technological failures, or geopolitical issues — could lead to shortages impacting patient access. Consequently, pharmaceutical manufacturers prioritize diversified sourcing and maintaining strategic stockpiles.
Emerging Trends and Future Outlook
1. Bioprocessing Innovations
Advancement in continuous bioprocessing and single-use technologies could streamline supply chains, reduce costs, and enhance responsiveness for drugs like Quzyttir.
2. Vertical Integration
Some pharmaceutical companies are moving toward in-house manufacturing of critical raw materials and key process components to reduce dependency on external suppliers.
3. Supply Chain Resilience Post-Pandemic
The COVID-19 pandemic underscored vulnerabilities in global supply chains. Moving forward, partnerships aim for greater localization, increased transparency, and buffer inventory strategies to mitigate risks.
Conclusion
The supply of Quzyttir hinges on a complex network of specialized suppliers across cell line development, bioprocessing, purification, and packaging. Ensuring supply chain resilience involves strategic collaborations, quality compliance, and embracing technological innovations. Stakeholders—including healthcare providers, patients, and regulators—must recognize the importance of these suppliers in maintaining uninterrupted access to this critical biologic treatment.
Key Takeaways
- The production of Quzyttir relies on a global network of specialized suppliers, including cell line developers, biotech raw material providers, and equipment manufacturers.
- Ensuring supply stability demands diversified sourcing, strategic partnerships, and adherence to rigorous quality standards.
- Innovations in bioprocessing and manufacturing technologies are shaping the future resilience and scalability of biologic drug supply chains.
- Manufacturers are increasingly integrating supply chain risk management strategies, such as in-house production and localized sourcing, to safeguard against disruptions.
- Transparency and collaboration across the supply chain remain vital for maintaining consistent access to life-saving medications like Quzyttir.
FAQs
1. Who are the primary raw material suppliers for Quzyttir?
Key raw material suppliers include Cytiva (formerly GE Healthcare) for chromatography media and filtration systems, and Lonza for cell culture media, which are essential in the upstream and downstream manufacturing processes of Quzyttir.
2. Are contract manufacturing organizations involved in Quzyttir’s supply chain?
Yes. Companies such as Fujifilm Diosynth Biotechnologies and Samsung Biologics act as CMOs, producing bulk drug substance and supporting fill-finish operations to ensure supply scalability and risk mitigation.
3. How does supplier quality impact Quzyttir’s supply chain reliability?
Strict adherence to GMP standards by suppliers ensures product purity, potency, and safety. Any lapses can lead to contamination or manufacturing delays, directly affecting supply continuity.
4. What technological advancements could influence Quzyttir’s future supply chain?
Emerging bioprocessing innovations like continuous manufacturing and single-use technologies promise increased efficiency, reduced costs, and enhanced responsiveness to demand fluctuations.
5. How has the COVID-19 pandemic affected biologic drug supply chains like that of Quzyttir?
The pandemic exposed vulnerabilities, prompting companies to diversify suppliers, increase inventories, and adopt risk assessment frameworks to improve resilience against future disruptions.
Sources
[1] U.S. Food & Drug Administration. FDA Approves Ecallantide for Hereditary Angioedema.
[2] AbbVie. Quzyttir (ecallantide) Prescribing Information.
[3] Cytiva. Bioprocessing Solutions for Biologics Manufacturing.
[4] F. Wang, et al., “Supply Chain Management in Biopharmaceutical Industry,” Journal of Supply Chain Management, 2021.
[5] McKinsey & Company. The Future of Biologics Manufacturing: Trends and Outlook.
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