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Sterile Injectable CDMO Drug Product Development

Terumo Medical Care Solutions – Pharmaceutical provides comprehensive contract development and manufacturing organization (CDMO) formulation development services for a range of sterile injectable product types. Our CDMO drug development teams are experienced in parenteral formulation development, technology transfer processes and supporting regulatory filings with leading regulatory bodies such as the U.S. FDA, EMA and PMDA.
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Description
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Formulation Development
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Characteristics
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Integrated CDMO Services
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Downloads
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Contact
Terumo Early Phase Parenteral Formulation Development
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Early phase parenteral formulation development transforms active pharmaceutical ingredients (APIs) into a safe, effective, and stable injectable drug products intended for human clinical use. Our formulation scientists and device engineers assess formulation compatibility with the selected polymer prefilled syringe (PFS), as well as manufacturability and patient considerations. The result is a finely tuned match between formulation and PFS designed to meet the stability, bioavailability, manufacturability, compliance and patient adherence requirements of the customer’s injectable product.
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CDMO Injectable Drug Product Development Expertise
  • Range of drug modalities - mAbs, proteins, peptides and low solubility formulations
  • Viscous formulations up to 120 cP
  • Bio-hazard capabilities - Bio-Safety Level 2 (BSL 2)
  • Toxicity handling - Occupational Exposure Band 4 (OEB 4)
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CDMO Sterile Injectable Drug Product Development Services
  • Injectable formulation development and optimization
  • Prefilled syringe primary container interaction/compatibility studies
  • Definition of primary container specifications
  • Accelerated stability studies under range of ISO conditions
  • GMP clinical trial materials (CTM) manufacturing for injectables
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Primary Container Manufacturing (PFS)
/content/psd-ia/en/cdmo/primary-container-manufacturing
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CDMO Drug Product Development and Formulation
/content/psd-ia/en/cdmo/drug-product-formulation-development
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CDMO Aseptic Filling
/content/psd-ia/en/cdmo/aseptic-filling-visual-inspection
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Drug Delivery Device Assembly CDMO Services
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/content/psd-ia/en/cdmo/device-assembly
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CDMO Labelling & Packaging Services
/content/psd-ia/en/cdmo/labelling-packaging-palletizing
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CDMO Regulatory Support Services
/content/psd-ia/en/cdmo/regulatory-support
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Terumo Integrated CDMO Brochure
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Download our CDMO services brochure to discover how Terumo Medical Care Solutions – Pharmaceutical can support your sterile injectable product manufacturing needs. From vials to prefilled syringes (PFS) at virtually any scale, we offer integrated CDMO services that deliver.
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CDMO Brochure
/content/dam/terumo-dam/internet-cms/en-emea/tmcs/psd/information-center-assets/brochures/terumo-pharmaceutical-solutions-integrated-cdmo-brochure.pdf
Download Brochure
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Contact

Contact Terumo Pharmaceutical About Injectable CDMO Services

We are here to help bring your injectable product to market with our integrated CDMO services. Contact us today for more information about our parenteral CDMO services.
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