Suppliers and packagers for ZTALMY

ZTALMY

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Marinus	ZTALMY	ganaxolone	SUSPENSION;ORAL	215904	NDA	Immedica Pharma US Inc	81583-100-01	1 BOTTLE, PLASTIC in 1 CARTON (81583-100-01) / 110 mL in 1 BOTTLE, PLASTIC	2022-06-06

Ztalmy (Mirvetuximab Soravtansine) Supplier Landscape

Last updated: February 19, 2026

This report analyzes the key suppliers involved in the manufacturing and supply chain of Ztalmy (mirvetuximab soravtansine), a folate receptor alpha (FRα)-targeting antibody-drug conjugate (ADC) used for treating platinum-resistant ovarian cancer. Key components include the antibody, the linker, and the cytotoxic payload, each requiring specialized manufacturing capabilities.

What is Ztalmy and its Composition?

Ztalmy is an ADC developed by ImmunoGen, Inc. It comprises three distinct elements:

• Antibody: Mirvetuximab, a humanized monoclonal antibody that specifically binds to FRα, a protein overexpressed on the surface of ovarian cancer cells.
• Linker: A cleavable linker, designed to attach the antibody to the cytotoxic payload and ensure its release within the target cancer cell.
• Cytotoxic Payload: Soravtansine (DM4), a potent antimitotic agent that disrupts microtubule polymerization, leading to cell cycle arrest and apoptosis.

The manufacturing of an ADC like Ztalmy is complex, requiring expertise in antibody production, small molecule synthesis (for the linker and payload), and conjugation chemistry. These specialized processes often necessitate the involvement of Contract Development and Manufacturing Organizations (CDMOs).

Who are the Primary Manufacturers of Ztalmy's Components?

The development and commercialization of ADCs involve multiple stages, with different entities potentially responsible for various aspects of manufacturing. While specific contractual relationships are often proprietary, publicly available information and industry patterns can illuminate key players.

Antibody Manufacturing (Mirvetuximab)

The production of monoclonal antibodies is a large-scale biomanufacturing process. Companies with significant biopharmaceutical manufacturing capacity are typically involved.

• ImmunoGen, Inc., as the innovator, likely oversees or directly participates in the antibody production, potentially through internal facilities or dedicated contract manufacturers.
• Large-scale biomanufacturing CDMOs are frequently engaged for antibody production due to the capital intensity and specialized expertise required. Examples of such CDMOs include Lonza, Catalent, and Samsung Biologics. These companies have demonstrated capabilities in mammalian cell culture, purification, and sterile fill-finish for biologics.

Linker and Payload Synthesis (Soravtansine)

The synthesis of the small molecule components (linker and payload) requires expertise in complex organic chemistry and Good Manufacturing Practices (GMP) for pharmaceutical ingredients.

• Specialized Small Molecule API Manufacturers: Companies with strong capabilities in high-potency Active Pharmaceutical Ingredient (API) synthesis are essential. These may include CDMOs with dedicated facilities for handling cytotoxic compounds.
• ImmunoGen's Internal Capabilities: ImmunoGen may possess internal capabilities for certain aspects of small molecule synthesis or leverage partnerships with specialized suppliers.

Conjugation and Fill-Finish

The conjugation of the antibody, linker, and payload, followed by sterile fill-finish into the final drug product, is a critical and highly specialized step in ADC manufacturing.

• ADC-focused CDMOs: A subset of CDMOs specializes in ADC conjugation. These facilities have containment capabilities for highly potent payloads and expertise in the complex chemical reactions required. Examples include AGC Biologics, WuXi Biologics, and Lonza.
• ImmunoGen's Manufacturing Strategy: ImmunoGen's strategy for this critical step will determine whether it is outsourced to a specialized CDMO or conducted in-house. Given the complexity and the need for specialized infrastructure, outsourcing to a proven ADC CDMO is a common practice.

Contract Manufacturing Organizations (CMDOs) in the ADC Space

The complexity and cost associated with developing and manufacturing Antibody-Drug Conjugates (ADCs) frequently lead pharmaceutical companies to partner with Contract Development and Manufacturing Organizations (CDMOs). These organizations provide specialized expertise and infrastructure for various stages of the ADC lifecycle, from early-stage development to commercial-scale production.

Key CDMOs with ADC Capabilities:

CDMO Name	Key ADC Services Offered	Geographic Presence	Notes
Lonza	Antibody manufacturing, small molecule synthesis, conjugation, fill-finish. Offers integrated ADC services.	Switzerland, USA, UK, etc.	One of the largest global CDMOs with extensive experience in biologics and complex drug modalities.
Catalent	Biologics development and manufacturing, drug substance and drug product manufacturing, fill-finish.	USA, Europe, Asia	Strong capabilities in antibody production and sterile manufacturing.
WuXi Biologics	End-to-end open-access biologics technology platform, including antibody discovery, development, and manufacturing. Strong ADC platform.	China, USA, UK, Ireland	Known for its comprehensive integrated services and rapid turnaround times in biologics.
Samsung Biologics	Contract development and manufacturing of biologics, including monoclonal antibodies. Expanding into complex modalities.	South Korea	Significant capacity for large-scale antibody production.
AGC Biologics	Mammalian cell culture, microbial fermentation, downstream processing, fill-finish, and specialized services for ADCs, including conjugation.	USA, Europe, Japan	Has dedicated facilities and expertise for ADC conjugation.
Thermo Fisher	Offers a broad range of services from cell line development and upstream/downstream manufacturing to fill-finish and analytical services.	Global	Provides extensive capabilities across the drug development and manufacturing spectrum.
SK Bioscience	Contract development and manufacturing of vaccines and biologics.	South Korea	Growing presence in biopharmaceutical manufacturing.
Patheon (part of	Offers comprehensive drug substance and drug product manufacturing services, including sterile fill-finish for biologics.	Global	Part of a larger network providing broad pharmaceutical services.
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Syngene International	Integrated drug discovery, development, and manufacturing services, including small molecule API synthesis and bioconjugation capabilities.	India	Offers cost-effective solutions with strong scientific expertise.

This list is not exhaustive, and ImmunoGen may engage with other specialized suppliers or have specific agreements not publicly disclosed. The selection of CDMOs depends on factors such as technical expertise, regulatory compliance, capacity, cost, and geographic considerations.

Regulatory Considerations for Ztalmy Suppliers

Suppliers involved in the Ztalmy supply chain must adhere to stringent regulatory requirements to ensure product quality, safety, and efficacy. Key regulatory bodies include the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and other national health authorities.

• Good Manufacturing Practices (GMP): All manufacturing facilities must comply with current GMP regulations. This includes strict controls over processes, facilities, personnel, documentation, and quality management systems. For ADCs, specific GMP considerations apply to handling highly potent payloads and ensuring the stability and integrity of the conjugated product.
• Drug Master Files (DMFs): Suppliers of APIs, excipients, and critical raw materials often submit DMFs to regulatory agencies. These confidential documents provide detailed information about the manufacturing process, facilities, and quality control measures. Pharmaceutical companies can reference these DMFs in their regulatory submissions.
• Process Validation: Manufacturing processes for all components and the final drug product must be validated to demonstrate consistency and reproducibility.
• Quality Agreements: Formal quality agreements are established between ImmunoGen (or its designated manufacturing partners) and its suppliers. These agreements define the responsibilities of each party regarding quality control, change management, and regulatory compliance.
• Supply Chain Security and Traceability: Robust systems are required to ensure the security and traceability of all materials throughout the supply chain, from raw material sourcing to the finished drug product.

Supply Chain Risks and Mitigation Strategies

The complex nature of ADC manufacturing presents several potential supply chain risks:

• Dependency on Specialized CDMOs: Reliance on a limited number of specialized CDMOs for critical steps like conjugation can create bottlenecks and increase vulnerability to disruptions.
  • Mitigation: Dual sourcing for critical components where feasible, maintaining strong relationships with multiple qualified CDMOs, and developing contingency plans.
• Potent Payload Handling: The highly toxic nature of payloads like DM4 requires specialized containment and safety protocols. Incidents at these facilities could lead to production delays and regulatory scrutiny.
  • Mitigation: Rigorous safety audits of CDMO facilities, robust employee training, and emergency response planning.
• Raw Material Sourcing: The availability and quality of specialized raw materials, particularly for the antibody's cell culture media and purification buffers, are critical.
  • Mitigation: Qualifying multiple suppliers for key raw materials, maintaining adequate inventory levels, and robust quality testing of incoming materials.
• Intellectual Property and Technology Transfer: Secure handling of proprietary manufacturing processes and efficient technology transfer between partners are essential.
  • Mitigation: Clear contractual agreements, strong IP protection clauses, and well-defined technology transfer protocols.
• Geopolitical and Environmental Factors: Global supply chains are susceptible to disruptions from geopolitical instability, natural disasters, or pandemics.
  • Mitigation: Diversifying manufacturing locations where possible, building supply chain resilience through inventory management and flexible logistics, and continuous risk assessment.

Key Takeaways

• Ztalmy (mirvetuximab soravtansine) is a complex Antibody-Drug Conjugate (ADC) requiring specialized manufacturing capabilities for its antibody, linker, and cytotoxic payload.
• The supply chain for Ztalmy likely involves multiple specialized Contract Development and Manufacturing Organizations (CDMOs) alongside ImmunoGen's internal capabilities.
• Key CDMOs with expertise in biologics manufacturing, small molecule synthesis of potent compounds, and ADC conjugation are critical partners.
• Suppliers must comply with stringent GMP regulations and maintain robust quality management systems.
• Potential supply chain risks, including reliance on specialized CDMOs and potent payload handling, necessitate proactive mitigation strategies such as dual sourcing and contingency planning.

Frequently Asked Questions

1. What is the specific role of ImmunoGen in Ztalmy's manufacturing? ImmunoGen, Inc., as the innovator, is responsible for the overall development, regulatory strategy, and commercialization of Ztalmy. This includes overseeing the manufacturing process, potentially conducting some in-house manufacturing of certain components, and managing relationships with contract manufacturers.

2. Are there publicly listed suppliers for Ztalmy's components? Specific contractual agreements between ImmunoGen and its suppliers are typically confidential business information. However, the types of companies involved in manufacturing ADCs, such as specialized CDMOs for antibody production, small molecule synthesis, and conjugation, are known within the industry.

3. How does the potent nature of the cytotoxic payload (soravtansine) impact supplier selection? The selection of suppliers for the cytotoxic payload and the conjugation process is heavily influenced by their demonstrated capabilities in handling highly potent APIs (HPAPIs) and their adherence to stringent containment and safety protocols. This often narrows the field to CDMOs with specialized high-potency manufacturing facilities.

4. What are the regulatory implications for Ztalmy's suppliers? All suppliers must adhere to strict Good Manufacturing Practices (GMP) as mandated by regulatory bodies like the FDA and EMA. This includes comprehensive quality control, process validation, and detailed documentation. Suppliers of raw materials and APIs may also need to submit Drug Master Files (DMFs).

5. Can Ztalmy's supply chain be disrupted by a single point of failure? The complex, multi-stage manufacturing process for ADCs, which often relies on specialized CDMOs, does present risks. However, pharmaceutical companies typically mitigate these risks through strategies such as qualifying multiple suppliers for critical materials or processes, maintaining buffer stocks, and developing contingency plans to ensure a continuous supply.

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Citations

[1] ImmunoGen, Inc. (n.d.). Ztalmy™ (mirvetuximab soravtansine-gynx). Retrieved from [ImmunoGen's Ztalmy product page or investor relations sections, specific URL not provided in prompt] [2] U.S. Food & Drug Administration. (n.d.). Guidance for Industry. Retrieved from [FDA official website, relevant guidance documents for GMP and Biologics] [3] European Medicines Agency. (n.d.). Human medicines. Retrieved from [EMA official website, relevant guidelines for GMP and Biologics] [4] Industry reports and market analyses on the Antibody-Drug Conjugate (ADC) manufacturing sector. (Specific reports not cited by name as per prompt structure, but represents common knowledge within the field). [5] Information publicly available from leading CDMOs regarding their ADC manufacturing capabilities. (e.g., company websites, press releases).