Lyophilization
HALIX is specialized in freeze drying and lyophilization cycle development of biopharmaceuticals from clinical to commercial scale
Lyophilization
Pharmaceutical companies often use lyophilization, also known as freeze-drying, to keep the product quality unchanged and increase the shelf life. Sublimation under vacuum withdraws water from the pharmaceutical product.
Lyophilized products can be easily stored, shipped, and reconstituted to an injectable. The dehydration process does not affect molecular product structures.
Lyophilization Cycle Development
As lyophilization is an expensive process, it is of high importance to develop economical freeze-drying cycles suitable for larger-scale production of the product. HALIX is experienced in the development, optimization, scale-up and transfer of lyophilization processes for (bio)pharmaceutical drugs.
For the lyophilization cycle development appropriate process parameters will be identified and optimized: freezing conditions, freezing rate, shelf temperature during freezing, duration of the freezing step, primary and secondary drying conditions, shelf temperature and pressure.
HALIX Full Service Offering
HALIX can support you in development and improvement of a lyophilization (freeze drying) cycle for biopharmaceutical products. By performing runs with a small amount of material, with a lyophilization cycle proposed by our freeze-drying experts, we can design and/or optimize your lyophilization process.
In a later stage the cycle can be scaled up easily from lab-scale to full scale lyophilizer to be directly implemented for your clinical and commercial scale batches. Parameters set in the pilot freeze dryer therefore also apply in the industrial freeze-dyer, thereby increasing stability and shelflife of your products.
Production Facility Parameters
Our pilot freeze dryer has a 0.5 m2 plate and is used typically for lyophilization cycle development programmes. With a 5.2 m2 plate capacity in the commercial lyophilizer, batches up to 20.000 vials can be processed at the same time.
HALIX performs fill and freeze directly after filling as we have an industrial vacuum dryer linked to our automated filling line. The GMP certified freeze dryer can create lyophilized vials for our complete validated range.
To find out how we can support your needs in GMP confirm lyophilization and lyophilization cycle development, contact our dedicated staff.
