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Description

Terumo Medical Care Solutions - Pharmaceutical Solutions Division’ contract development and manufacturing organization in Japan

We provide sterile injectable contract development and manufacturing (CDMO) services from initial combination device design and formulation development to commercial manufacturing, supporting better patient experience around the world. Our integrated systems, technical solutions and advanced cGMP capabilities include:

Our team understands how challenging combination device and formulation can be, especially in support of the efficacy and safety of self-administered biotech drugs. Joining our expertises in design, engineering and manufacturing prefillable syringes, drug delivery devices in combination with aseptic fill finish and device assembly operation, we deliver world class solutions to global pharma industry.

Our Capabilities

Simplify device/formulation complexity with us

Our approach to combination product manufacturing is tailored specifically to design devices and processes that are friendly to sensitive protein formulations, biopharmaceuticals and specialized compounds.

We ensure the quality of your final product by selecting materials that are expected to minimize leachables and particles, and by reducing human intervention through an aseptic manufacturing line that is consistent from preparation and filling to assembly.

We offer parenteral drug developers more:

  • Exclusive access to advanced to an integrated portfolio of combination parenteral drug delivery technologies
  • A device engineering team that specializes in understanding challenges and resolving issues related to matching large, middle, and small molecule formulations to PFS, device, process and patient
  • A formulation team experienced in parenteral drug formulation development, technology transfer and regulatory filing
  • Sterile aseptic capacity with flexible capacities, automation and controls for all phases of clinical development and commercialization
  • A strategically located development and manufacturing partner with the regulatory experience to help launch products in markets all over the world faster and more successfully

In addition to continuous improvement to production systems to more efficiently match formulation characteristics and devices, we offers newly expanded production capacity across its three facilities in Japan, which are cGMP compliant and certified by PMDA as well as overseas regulatory authorities including the FDA and EMA.


Technologies and expertise

Advanced syringe design and material science

 Pioneer of Japan's first domestic market plastic syringe, Terumo leads material science innovation. We offer a full range of commercial portfolio including Ready-to-Fill PLAJEX™ Cyclo Olefin Polymer (COP) Syringes.

Polymer, silicone oil-free coatings

 Terumo created the first silicone-oil-free plastic syringe in the pharmaceutical industry through its proprietary polymer coating technology. Our unique technology reduces or eliminates the risk of oxidation and aggregation of proteins derived from silicone oil and achieves smooth sliding properties.

Precision needles

 Terumo has been engaged in the research and development of safe, high-quality needles. By combining technologies, we aim to develop injection needles with high added value that meet the needs of medical sites – needle technology is integrated into PFS products.

Sterilization for sensitive products

 Terumo has advanced technology that enables high-temperature and high-pressure autoclave sterilization without altering plastic containers. Biopharmaceuticals that is sensitive to high temperature can be filled and sealed in an aseptic area using an isolator.

Contained aseptic processes

 Terumo’s, integrated line can handle everything from container molding to filling, sealing and packaging. Offering fill and finish flexibility Terumo can optimize process to match the characteristics of the chemical solution.

Advanced engineering and design

 Leveraging Terumo’s experience with material science it is possible to develop combination devices that pursue formulation and user compatibility and down to the smallest detail.

Capability on device assembly

 A fully automated process, allows Terumo the possibility to assemble the device choosen by customers directly in their sites, in order to have the final combined product ready to be shipped.

Preparation



Downloads

Relevant product information
Terumo - CDMO Brochure.pdf

Please note that some products may not be available in all regions, check with your local TERUMO Medical Care Solutions - Pharmaceutical Solutions Division for details.
All brand names are trademarks or registered trademarks owned by TERUMO CORPORATION, its affiliates, or unrelated third parties.

Let’s Find Your Best Solution

Innovation and creativity are central to our value proposition. Our expert teams lead the industry in developing and manufacturing advanced, high-performing infusion and injection technologies for all parenteral applications.

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