Company insight
Integrated CDMO solutions T
Working with Terumo’s parenteral contract development and manufacturing organisation brings customers a uniquely integrated service offering.
erumo combines its high-quality polymer pre-fillable syringe manufacturing capabilities with its contract development and manufacturing organisation (CDMO) service offering, which includes formulation development, fill-finish services, device assembly and packaging, all in one trusted partner. For Terumo’s customers, integrated innovation means end-to-end services that deliver injectable products of the highest quality, compliance and with reduced time to market.
The syringe experience Terumo started producing its first disposable plastic syringes in 1963 and has continued to invest in the latest syringe technologies ever since. Glass is historically known for its chemical inertness and therefore widely used as the primary material for pre-fillable syringes. Terumo recognised the limitations of glass syringes and developed innovative pre-fillable polymer syringes with higher resistance to breakage and dimensional accuracy for the pharmaceutical market. Terumo has continued to innovate by bringing together its industry- leading polymer syringes with advanced formulation and sterile fill-finish services as an integrated CDMO. For more than two decades, Terumo has been recognised for the quality and service standards it provides to many of Japan’s leading biopharmaceutical companies for pre-filled syringe (PFS) CDMO development and manufacturing.
The CDMO difference
Having recently expanded its CDMO offering to biopharmaceutical companies around the world, Terumo has positioned itself to meet global industry requirements successfully. Combining the global standard in polymer PFS supply with exceptional sterile formulation development services through a uniquely coordinated approach provides significant advantages to Terumo’s CDMO customers.
By working as a single supplier with an
www.worldpharmaceuticals.net Terumo’s CDMO solutions integrate with its high-quality polymer pre-fillable syringe manufacturing capabilities.
unmatched understanding of the capabilities of its own syringes, Terumo is able to select the best device for each individual project. It also allows Terumo’s CDMO teams to co-ordinate the formulation and device development steps and to arrive at an optimal formulation quickly, considering all the various challenges presented by potential interactions between the drug and the device. Terumo’s highly efficient sterile filling operations use modern, flexible and highly automated sterile filling lines suitable for both clinical and commercial manufacturing volumes. The result is that Terumo’s integrated innovation approach can significantly de-risk a project, enabling accelerated timelines. There are many benefits of integrated innovation: ■
One partner: end-to-end service offering from formulation to final packaged product.
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Quality: systems that use the latest technologies and compliant processes to build quality into every aspect of its operations.
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Regulatory compliance: decades of experience compliantly engineering and manufacturing combination drug products and devices
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Reduced cost of ownership: lower investment cost to develop new molecules when working with a single supplier.
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Time to market: a single supplier accelerates supplier qualification,
validation and communication. ■
Supply chain simplification: one single source for device technology and drug product development and manufacturing services, from small clinical batches to commercial- scale production.
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Consulting and engineering support: provided through development plans, regulatory applications and high-value- added products.
Terumo’s integrated approach to offering complete, single-source CDMO services for PFSs is innovative. Considering that Terumo was founded on developing leading-edge medical products and services, it is easy to see why innovation is such a big part of the company’s heritage and way of thinking. Terumo has always sought to create solutions to the challenges its customers face. Decades of expertise were applied to develop Terumo’s industry- leading polymer-based syringes that have since become the global industry standard. Terumo’s innovative proprietary silicone oil-free containers, in combination with i-coating technology (chemically bonded coating) present on the stoppers, can mitigate issues related to silicone oil, providing superior molecule protection. All of these technological innovations came from Terumo’s scientists and engineers. ●
www.terumo-europe.com/en-emea 17
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