Suppliers and packagers for LYMPHOSEEK KIT

LYMPHOSEEK KIT

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Cardinal Health 414	LYMPHOSEEK KIT	technetium tc-99m tilmanocept	INJECTABLE;INJECTION	202207	NDA	Cardinal Health 414, LLC	65857-425-05	1 KIT in 1 CARTON (65857-425-05) / 1 KIT in 1 KIT * 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (65857-400-01)	2017-09-20
Cardinal Health 414	LYMPHOSEEK KIT	technetium tc-99m tilmanocept	INJECTABLE;INJECTION	202207	NDA	Cardinal Health 414, LLC	65857-450-05	1 KIT in 1 CARTON (65857-450-05) / 1 KIT in 1 KIT * 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (65857-400-01) * 1 INJECTION, SOLUTION in 1 VIAL (65857-401-45)	2017-09-20

Lymphoseek Kit Suppliers

Last updated: February 19, 2026

This analysis identifies key suppliers and manufacturing capabilities for the Lymphoseek kit, a critical component in oncologic diagnostics. Data focuses on active pharmaceutical ingredient (API) synthesis, formulation, lyophilization, and packaging.

What is Lymphoseek and its Application?

Lymphoseek (technetium Tc 99m tilmanocept) is a radiopharmaceutical used for lymphatic mapping and sentinel lymph node biopsy in patients with cancer. It is administered via injection near a tumor site and then detected by a gamma counter to identify the sentinel lymph node(s) for removal. This procedure helps determine if cancer has spread to the lymph nodes, influencing treatment decisions. Lymphoseek is manufactured by Navidea Biopharmaceuticals Inc. [1].

Key Components and Manufacturing Stages

The Lymphoseek kit comprises several critical components, each requiring specialized manufacturing processes:

• Active Pharmaceutical Ingredient (API): Tilmanocept is the API. Its synthesis involves complex organic chemistry.
• Radiolabeling: The API is radiolabeled with Technetium-99m (Tc-99m) immediately prior to administration. The kit itself does not contain Tc-99m but is designed for this subsequent labeling step.
• Formulation: The API is formulated into a sterile, injectable solution.
• Lyophilization: The formulated product is typically lyophilized (freeze-dried) to ensure stability and extend shelf life.
• Sterile Filling and Packaging: The lyophilized product is filled into sterile vials and packaged for distribution.

Identified Suppliers and Contract Manufacturing Organizations (CMOs)

Navidea Biopharmaceuticals Inc. oversees the entire supply chain and manufacturing process for Lymphoseek. While Navidea is the primary entity, the production involves specialized CMOs and raw material suppliers.

API Synthesis (Tilmanocept)

The synthesis of tilmanocept, a novel molecular entity, is a proprietary process. Navidea likely maintains in-house expertise or contracts with highly specialized API manufacturers.

• Navidea Biopharmaceuticals Inc.: Holds the investigational new drug (IND) and new drug application (NDA) for Lymphoseek. Responsible for the overall manufacturing strategy. [1]
• Potential API CMOs: Companies with expertise in complex carbohydrate synthesis and peptide conjugation are candidates. Specific CMOs involved are not publicly disclosed by Navidea.

Formulation, Lyophilization, and Sterile Fill-Finish

These downstream manufacturing steps require cGMP-compliant facilities capable of aseptic processing.

• Navidea Biopharmaceuticals Inc.: While Navidea designs and oversees the process, they may not operate all manufacturing facilities directly.

• Contract Manufacturing Organizations (CMOs): The pharmaceutical industry relies heavily on CMOs for formulation, lyophilization, and sterile fill-finish. Companies with extensive experience in radiopharmaceutical manufacturing are critical.

  • Notable CMOs with relevant capabilities:
    • Sharp Packaging Solutions: Offers sterile fill-finish and lyophilization services. [2]
    • Catalent Pharma Solutions: Provides integrated manufacturing services including lyophilization and sterile fill-finish for complex biologics and small molecules. [3]
    • Patheon (part of Thermo Fisher Scientific): A large CMO with broad capabilities, including sterile fill-finish and lyophilization. [4]
    • Vetter Pharma-Technik: Specializes in aseptic fill and finish of injectables. [5]

Raw Material and Reagent Suppliers

The synthesis of tilmanocept and its formulation requires various chemical reagents, excipients, and packaging materials.

• Chemical Reagent Suppliers:
  • Sigma-Aldrich (Merck KGaA): A broad supplier of chemicals for research and manufacturing.
  • Thermo Fisher Scientific: Offers a wide range of laboratory chemicals and reagents.
• Excipient Suppliers:
  • Roquette: Provides pharmaceutical excipients.
  • BASF: Offers a portfolio of pharmaceutical ingredients.
• Vial and Stopper Suppliers:
  • Schott Pharmaceutical Packaging: A leading supplier of borosilicate glass vials and stoppers. [6]
  • West Pharmaceutical Services: Provides integrated solutions for pharmaceutical packaging, including stoppers and seals. [7]

Regulatory Landscape and Compliance

The manufacturing of Lymphoseek and its components is subject to stringent regulatory oversight by the U.S. Food and Drug Administration (FDA) and other global health authorities.

• Current Good Manufacturing Practices (cGMP): All manufacturing facilities involved must adhere to cGMP regulations to ensure product quality, safety, and efficacy. [8]
• Drug Master Files (DMFs): Suppliers of APIs and critical excipients often maintain DMFs with the FDA, providing confidential detailed information about their manufacturing processes.
• Navidea's Regulatory Submissions: Navidea's NDA for Lymphoseek detailed the manufacturing processes and controls in place. [1]
• Quality Agreements: Robust quality agreements between Navidea and its CMOs and suppliers are essential to define responsibilities and ensure compliance.

Supply Chain Considerations and Risks

The production of a radiopharmaceutical kit involves specific supply chain challenges:

• Specialized Equipment: Lyophilization and aseptic filling require highly specialized and validated equipment.
• Short Shelf Life of Tc-99m: While the kit is stable, the radiolabeling step uses a short-lived isotope (Tc-99m, half-life ~6 hours), requiring on-demand preparation at the healthcare facility. This influences demand forecasting and distribution logistics for the unlabeled kit.
• Limited Number of Qualified CMOs: The pool of CMOs with experience in sterile radiopharmaceutical manufacturing is smaller than for conventional drugs.
• Geopolitical and Supply Chain Disruptions: Global events can impact the availability of raw materials and the operational capacity of CMOs.
• Regulatory Changes: Evolving regulatory requirements can necessitate process modifications and revalidation.

Key Takeaways

• Lymphoseek kit manufacturing involves specialized API synthesis, formulation, lyophilization, and sterile fill-finish.
• Navidea Biopharmaceuticals Inc. is the sole holder of the NDA and directs the overall manufacturing and supply chain.
• Specialized Contract Manufacturing Organizations (CMOs) are critical for formulation, lyophilization, and sterile fill-finish.
• Suppliers of raw materials, excipients, and primary packaging are integral to the production process.
• Strict adherence to cGMP and robust quality agreements are paramount due to the radiopharmaceutical nature of the product.
• Supply chain risks include reliance on a limited number of qualified CMOs and the specialized nature of radiopharmaceutical production.

Frequently Asked Questions

• Who are the primary manufacturers of the Lymphoseek kit? Navidea Biopharmaceuticals Inc. is the holder of the new drug application and oversees the manufacturing process, which involves specialized contract manufacturing organizations (CMOs).

• What are the key components of the Lymphoseek kit requiring specific suppliers? The key components include the active pharmaceutical ingredient (tilmanocept), excipients for formulation, sterile vials, and stoppers.

• What regulatory standards must be met by Lymphoseek kit suppliers? All suppliers and manufacturing partners must adhere to Current Good Manufacturing Practices (cGMP) as mandated by regulatory bodies such as the U.S. Food and Drug Administration (FDA).

• Does the Lymphoseek kit contain Technetium-99m? No, the Lymphoseek kit does not contain Technetium-99m. It is designed to be radiolabeled with Tc-99m by the healthcare provider immediately prior to administration.

• What are the potential challenges in the Lymphoseek supply chain? Challenges include the limited number of CMOs experienced in sterile radiopharmaceutical manufacturing, the need for specialized equipment, and the potential for disruptions in the global supply of raw materials and components.

Citations

[1] Navidea Biopharmaceuticals Inc. (n.d.). Lymphoseek® (technetium Tc 99m tilmanocept) injection. Retrieved from [Navidea's official website or SEC filings, if readily available - Placeholder for actual source]

[2] Sharp Packaging Solutions. (n.d.). Lyophilization Services. Retrieved from [Sharp Packaging Solutions website - Placeholder for actual source]

[3] Catalent Pharma Solutions. (n.d.). Sterile Drug Product Development and Manufacturing. Retrieved from [Catalent Pharma Solutions website - Placeholder for actual source]

[4] Thermo Fisher Scientific. (n.d.). Patheon Pharmaceutical Services. Retrieved from [Thermo Fisher Scientific website - Placeholder for actual source]

[5] Vetter Pharma-Technik. (n.d.). Aseptic Filling. Retrieved from [Vetter Pharma-Technik website - Placeholder for actual source]

[6] Schott Pharmaceutical Packaging. (n.d.). Vials. Retrieved from [Schott Pharmaceutical Packaging website - Placeholder for actual source]

[7] West Pharmaceutical Services. (n.d.). Primary Packaging Components. Retrieved from [West Pharmaceutical Services website - Placeholder for actual source]

[8] U.S. Food and Drug Administration. (n.d.). Current Good Manufacturing Practice (CGMP) Regulations. Retrieved from [FDA website - Placeholder for actual source]