When your project requires lyophilization, rely on Patheon for expertise in the development, optimization, and scale-up these complex formulations. Our broad experience spans a large number of projects and a variety of large and small molecules. In addition to our deep knowledge, we also offer the expansive resources, technologies, and range of vial forms and sizes to deliver exactly the right solution for your project.
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.
- Analytical development
- Formulation development
- Biopharmaceutical development
- Process design and clinical manufacturing
- Commercial manufacturing
- High potency compounds (category 3B)
- 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
Case Study: Seamless Scale-Up of Lyophilized Vial Products
The Challenge To scale-up three different products from our PDS lab unit to our GMP 7m2 system while maintaining consistency.
The Solution The first product contained a recombinant protein, and as is common practice in lyophilized formulations of pharmaceutical proteins, a surfactant agent was included. This protected against surface-induced denaturation, minimized risk of aggregates in the final rehydrated product, and provided protection during rehydration. The second product was a suspension of an oligopeptyde formulated in a mixture of water and ethanol. Co-solvent systems were employed to increase the sublimation rate, resulting in decreased drying time. The third product was a monoclonal antibody formulated in a buffer.
The Outcome The batch-to-batch consistency was excellent for all three products. All key product analytical properties, especially those sensitive to lyophilization, were maintained in the scale-up.