Product/Service
Lyophilized Vials
Source: Patheon Inc.
When your project requires lyophilization, rely on Patheon for expertise in the development, optimization, and scale-up these complex formulations.
Patheon offers lyophilization services with seamless scale-up from development to commercial manufacturing. We have a full range of equipment from 0.2 sqm pilot lab unit to 42 sqm in the same facility. This allows us to maintaining precision and accuracy of process conditions between units, while saving our customers time and money.
Lyophilization 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
- Easily accommodates small-scale volumes
- Option to commit to commercial batches while still in development
- Simplified regulatory process