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Patheon Overview Brochure

Prefilled Syringes

Rely on Patheon for expertise in the development, optimization, and scale-up of prefilled syringes. Our broad experience spans a large number of projects and a wide variety of large and small molecules. In addition to our deep knowledge, we also offer the expansive resources, technologies, and range of forms and sizes to deliver exactly the right solution for your project.

This dose form is popular with patients for its ease of use, which makes it popular with pharmaceutical companies for the lifecycle management opportunities it presents.

With a full range of equipment in the same facility, Patheon offers seamless scale-up from development to commercial manufacturing. This allows us to maintain precision and accuracy of process conditions, while saving our customers time and money.


Key Features

  • Syringe sizes 0.5 ml to 20 ml glass and polymer
  • Batch sizes from 40L to 1,000L or up to 150,000 units
  • Filling line speeds up to 600/min
  • Terminal sterilization
  • Cold storage 2° – 8°C
  • Fully automated inspection

Capabilities

  • Analytical development
  • Formulation development
  • Biopharmaceutical development
  • Process design and clinical manufacturing
  • Commercial manufacturing
  • High potency compounds (category 3B)

Advantages

  • Wide range of vial sizes, including ISO standard vials
  • Full regulatory approval, including AIFA, ANVISA, Brazilian Sanitary Surveillance Agency, BSI, BSI/MDA, Canadian Ministry of Health, FDA, GCC States Health Authority, Health Canada (HPFBI), KFDA, MCA, MHRA, Saudi MOH, Taiwan Health Authority, TNO
  • Clinical and commercial batches filled on the same filling line
  • Option to commit to commercial batches while still in development
  • Simplified regulatory process

*A new commercial-scale GMP prefilled-syringe and cartridge area is currentlyunder construction and will be operational by early 2014.


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