Services

MEDINET – ONE-STOP Solution Provider Our expertise in regenerative medicine and cell therapy for your success

MEDINET is an experienced cell-processing enterprise and well-known Contract Development and Manufacturing Organization (CDMO). MEDINET is the only CDMO offering solutions for the entire regenerative medicine and cell therapy value chain, from pre-clinical research through to development, manufacturing, and commercial launch. With our support, medical institutions, research institutions, and biopharmaceutical companies can seamlessly implement regenerative medicine and cell therapy in Japan.

Unparalleled expertise in patient-specific cell therapy development
and manufacturing accelerates client success.

MEDINET offers advanced value-added development and manufacturing expertise to help our clients achieve clinical and commercial success.

  • Manufacturing
    • Regenerative Medical Products/
      Investigational Products
    • Specified Cell Products
  • Value Chain Solutions
    • Technology Transfer and Process Development
    • Quality Control and Quality Assurance
    • Logistics etc.

Manufacturing

With experience in over 170,000 instances of patient-specific cell processing, we offer industry-leading value-added development and manufacturing expertise to help our clients achieve clinical and commercial success. MEDINET’s contract manufacture accelerates development and manufacture of our client’s product/cell therapy in Japan. According to the needs of our each client and the Japanese regulations, MEDINET can manufacture both:

  • Regenerative Medical Products / Investigational Products, and
  • Specified Cell Products

Manufacturing Regenerative Medical Products/Investigational Products

Regenerative medical products are defined as products distinct from pharmaceutical and medical devices under the Act on Pharmaceuticals and Medical Devices and not defined as specified cell products under the Act on the Safety of Regenerative Medicine. We help our clients develop and commercialize regenerative medical products/investigational products.

Our strategic approach includes:
  • Development and Manufacturing of Regenerative Medical Products / Investigational Products
  • Product Development Strategy
  • Process Development

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Manufacturing Specified Cell Products

MEDINET manufactures specified cell products defied as products under the Act on the Safety of Regenerative Medicine. We deal with any tissues and cells in order to help clients develop and growth with commercialization in mind, leveraging our unprecedented cell therapy-focused experience.

Expertise in multiple therapeutic applications such as:
  • Somatic Cell (CAR-T, Immuno-cells (e.g. Dendritic Cells, NK-cells, γδT-cells, αβT-cells), Cartilage, Myocardium, Fibroblast)
  • Somatic Stem Cell (Endodontium, Mesenchymal Stem Cells, Hematopoietic Stem Cells)
  • Induced Pluripotent Stem Cell (iPS cells, Embryonic Stem cells)

Expertise based on a solid track record

For over 15 years MEDINET provided a comprehensive solution, which includes technical know-how, facilities, systems, materials, professional cell-engineers, and other requirements to conduct immuno-cell therapy, to medical institutions as well as research institutions. Therefore, we support our clients to conduct immuno-cell therapy such as Dendritic Cell Vaccine Therapy, NK-cell Therapy, γδT-cell Therapy, αβT-cell Therapy and CTL Therapy.

 

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Value Chain Solutions

MEDINET is a one-stop regenerative medicine and cell therapy solution provider with expertise in new Japanese regulations for regenerative medicine. Delivering regenerative medicine and cell therapy treatments requires numerous processes ranging from cell culturing, freezing and preservation to examination and transport. Ensuring safety and efficiency requires varied, specialized expertise. MEDINET offers the accumulated technology and specialist human resources, as well as the manufacturing management, quality assurance, and personnel management expertise to flexibly meet client needs; from comprehensive programs to processes combinations matching specific requirements.

  • Personnel training
  • Facility and equipment design
  • Facility operations and management
  • Preparation of standard operating procedures
  • Logistics network
  • Information system
  • Purchasing, and production management
  • Quality management system
  • Quality control and quality assurance
  • Technology transfer and process development

In order to maintain forward progress, MEDINET will work with you through:

  • GMP/GCTP Facility and Equipment Design (e.g. facility management, consultation on GMP/GCTP infrastructure and GMP/GCTP manufacturing)
  • Technology Transfer and Process Development
  • Manufacturing Development
  • Quality Control and Quality Assurance
  • Logistics
  • Regulatory Consultations

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