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Description

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

We provide sterile injectable contract development and manufacturing (CDMO) services from initial combination device design and formulation development to commercial manufacturing, improving pharmaceutical customers experience around the world.


*For more information about regulatory support, please contact Terumo

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 designing 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:

  • Access to advanced and 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 vial, PFS, device, process and patient
  • A formulation team experienced in parenteral drug formulation development, technology transfer and regulatory filing
  • Sterile aseptic capacity with automation and controls for all phases of clinical development and commercialization
  • Aseptic filling capabilities for multiple types of containers, enabling to support pharmaceutical companies from early drug development, starting clinical trials with vials and then transitioning to pre-filled syringes at regulatory registration

In addition to continuous improvement to production systems to more efficiently match formulation characteristics and devices, Terumo offers expanded production capacity across multiple facilities between Japan and Europe which are cGMP compliant and certified** by PMD, FDA and EMA.


**For more information about regulatory status of each plant, please contact Terumo

Technologies and expertise

Advanced syringe design and material science

 Terumo is key player of polymer syringes primary packaging for pharmaceutical industry. We offer a full range of commercial portfolio including Ready-to-Fill PLAJEX™ Cyclo Olefin Polymer (COP) Syringes.

Polymer, silicone oil-free coatings

 Terumo offers silicone-oil-free plastic syringe for pharmaceutical industry through its proprietary polymer coating technology. The silicone oil-free syringe system is designed to preserve sensitive biotherapeutics, providing consistent and predictable break loose and glide forces1.

Precision needles

 Terumo has been engaged in the research and development of needles. By combining technologies, we aim to develop injection needles 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

 From early drug development phase in order to launch clinical trials, Terumo can support pharmaceutical companies in processing glass vials and then later on as well, with capabilities of filling polymer pre-filled syringes.

Lyophilization

 With freeze-drying capabilities, Terumo can support pharmaceutical partners to achieve stability and extended shelf life for their drug formulations.

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 chosen by customers directly at our sites, in order to have the final combined product ready to be shipped.
1 Functional Evaluation and Characterization of a Newly Developed Silicone Oil-Free Prefillable Syringe System, Yoshino et al (2014) J Pharm Sc, 103: 1520-1528

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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