Suppliers and packagers for generic pharmaceutical drug: motixafortide acetate

motixafortide acetate

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Ayrmid Pharma	APHEXDA	motixafortide acetate	POWDER;SUBCUTANEOUS	217159	NDA	Gamida Cell Inc.	73441-062-01	1 VIAL, GLASS in 1 CARTON (73441-062-01) / 1.7 mL in 1 VIAL, GLASS	2025-06-15
Ayrmid Pharma	APHEXDA	motixafortide acetate	POWDER;SUBCUTANEOUS	217159	NDA	BioLineRx USA Inc	82737-073-01	1 VIAL, GLASS in 1 CARTON (82737-073-01) / 1.7 mL in 1 VIAL, GLASS	2023-09-08

Suppliers for the Pharmaceutical Drug: Motixafortide Acetate

Last updated: August 1, 2025

Introduction

Motixafortide acetate, an experimental peptide drug, has garnered significant interest in the pharmaceutical and biotech sectors due to its promising therapeutic potential. Primarily designed as a CXCR4 antagonist, motixafortide aims to mobilize hematopoietic stem cells, thereby supporting stem cell transplantation processes and potentially addressing other indications such as oncology and inflammatory disorders. The development and commercialization of motixafortide acetate hinge on a reliable supply chain composed of specialized manufacturers and suppliers capable of producing high-purity compounds under stringent regulatory standards. This article provides a comprehensive overview of the key suppliers involved in the production and distribution of motixafortide acetate, emphasizing their roles, capabilities, and strategic importance within this niche pharmaceutical landscape.

Supplier Landscape for Motixafortide Acetate

1. Chemical Synthesis and Manufacturing of Motixafortide Acetate

a. Contract Manufacturing Organizations (CMOs)

Motixafortide acetate, being a custom peptide synthesis, requires highly specialized manufacturing facilities equipped to produce peptides with high purity and batch-to-batch consistency. Contract manufacturing organizations (CMOs) serve as primary suppliers, ensuring scalable production compliant with Good Manufacturing Practices (GMP). These CMOs often partner with biotech firms to streamline the supply chain and ensure quality assurance.

• GMP Peptide Manufacturers
  Notable GMP-certified peptide synthesis companies include Polypeptide Group, Bachem, and Pepscan. These manufacturers possess advanced solid-phase peptide synthesis (SPPS) capabilities, enabling production of complex peptides such as motixafortide acetate with precise structural fidelity.

• Key Capabilities:

  • Synthesis of peptide sequences with modifications (e.g., acetate groups)
  • High-throughput purification processes
  • Quality control through mass spectrometry and chromatography
  • Validation under regulatory compliance (FDA, EMA standards)

b. Custom Synthesis Specialists

Specialist peptide chemists and custom synthesis firms like CordenPharma and GenScript offer tailored synthesis services, especially for preclinical and early clinical material. As the therapeutic advances through clinical trials, mass production phases often transition to large-scale CMO facilities.

2. Raw Material Suppliers for Peptide Synthesis

The raw materials for peptide synthesis, notably amino acids and coupling reagents, are supplied by established chemical suppliers:

• Merck (EMD Millipore): Supplies high-quality, pharmaceutical-grade amino acids and reagents required for peptide assembly.

• Cambridge Isotope Laboratories: Provides isotopically labeled amino acids, if needed for tracer studies.

• Sigma-Aldrich: Offers a broad portfolio of chemical reagents suitable for peptide synthesis, purification, and validation.

3. Regulatory and Quality Assurance Service Providers

Given the stringent regulatory landscape, suppliers for validation, testing, and release assays play a crucial role:

• Intertek, Eurofins, and Charles River Laboratories: Offer stability testing, bioanalytical testing, and regulatory compliance services. These entities ensure that the motixafortide acetate supplied meets pharmacopeial standards.

4. Packaging, Storage, and Distribution Channels

Post-synthesis, the peptide requires specialized storage conditions to retain stability:

• Cold Chain Logistics Providers: Companies like UPS Healthcare and DHL Global Forwarding ensure temperature-controlled transportation, critical for peptide drugs.

• Packaging Suppliers: Offer sterile, tamper-evident packaging compliant with pharmaceutical standards to prevent contamination.

Key Factors Influencing Supplier Selection

• Regulatory Compliance: Suppliers must maintain GMP standards, possess robust documentation practices, and be capable of scaling up production in line with clinical and commercial demands.

• Quality Assurance: Certification such as ISO 9001 and validation records are non-negotiable prerequisites.

• Capacity & Scalability: Ability to meet current and projected volume needs as clinical trials progress toward commercialization.

• Strategic Partnerships: Long-term collaborations can mitigate supply chain disruptions and facilitate technology transfer.

Strategic Implications for Stakeholders

For pharmaceutical developers and investors in motixafortide acetate, forging strong relationships with leading peptide synthesis CMOs and raw material suppliers minimizes risks and accelerates development timelines. Recognizing the specialized nature of peptide manufacturing, selecting suppliers with proven regulatory track records, and capacity for large-scale production are crucial for progressing through clinical phases and reaching market approval.

Future Outlook

The landscape for motixafortide acetate suppliers is poised for evolution, with emerging technologies such as automated peptide synthesis and continuous manufacturing promising to enhance scalability and cost-efficiency. Additionally, increased collaboration between biotech firms and contract manufacturers could broaden supplier options, fostering resilience in supply chains. As clinical data consolidates the therapeutic promise of motixafortide, securing a robust and compliant supply chain remains a critical priority.

Key Takeaways

• Specialized peptide manufacturing firms like Bachem and Polypeptide Group are central to supply chains for motixafortide acetate, offering GMP-certified synthesis services.

• Raw material suppliers such as Merck and Sigma-Aldrich ensure a consistent supply of high-quality amino acids and reagents necessary for peptide production.

• Regulatory testing and validation providers underpin quality assurance, critically ensuring compliance with global standards.

• Cold chain logistics are vital for transporting motixafortide acetate, necessitating partnerships with temperature-controlled logistics providers.

• Strategic supplier relationships influence commercialization success, emphasizing the need for scalable, compliant, and reliable manufacturing partnerships.

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Frequently Asked Questions (FAQs)

1. What are the primary challenges in sourcing motixafortide acetate?
The main challenges include ensuring GMP compliance, maintaining high purity levels, scaling production to meet clinical and commercial demands, and coordinating cold chain logistics to preserve peptide stability.

2. Are there multiple suppliers capable of producing motixafortide acetate?
Currently, a limited number of specialized peptide manufacturing firms with GMP accreditation are capable of synthesizing motixafortide acetate, with partnerships often under confidentiality agreements owing to the proprietary nature of the process.

3. How does the regulatory environment impact supplier choices?
Suppliers must adhere to strict FDA, EMA, and other international standards to ensure approval readiness. Validation, documentation, and traceability are critical, influencing selection decisions.

4. Is there potential for local manufacturing of motixafortide acetate?
Given the complexity and regulatory requirements, most production occurs at established international GMP-certified facilities, though local manufacturing may emerge as clinical and commercial scale increases.

5. What role do raw material suppliers play in ensuring drug quality?
They supply high-grade amino acids and reagents vital for peptide synthesis. Consistent raw material quality directly impacts the purity, efficacy, and safety of the final product.

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References

1. [1] Bachem. Peptide Manufacturing Capabilities. Bachem AG, 2022.
2. [2] Polypeptide Group. GMP Peptide Synthesis Services. Polypeptide Group, 2023.
3. [3] Sigma-Aldrich. Chemical Reagents for Peptide Synthesis. Sigma-Aldrich, 2023.
4. [4] Eurofins Scientific. Analytical Testing & Certification. Eurofins, 2023.
5. [5] DHL Healthcare. Cold Chain Logistics for Pharmaceuticals. DHL, 2023.