Lyophilization

Lyophilization can reduce shipping and storage costs and increase the long-term stability of a drug product compared to other drug delivery forms.  Lyophilized products can stay at room or refrigerated temperatures for years at a time, removing the need for unnecessary cold chain usage and allowing for strategic stockpiling of crucial medications in case of an emergency. To learn more, read “Four Reasons You Should Choose Lyophilization for Your Next Project.”

Sterile liquid injectables can often be lyophilized, including many kinds of biologics. However, some products cannot be lyophilized and need to stay in liquid form in cold storage during transport and in warehouse storage. Monoclonal antibodies are often a great candidate for lyophilization as they require strict temperature control in liquid form.  

Lyophilized products can remain stable at room temperature or refrigerated temperature for months, sometimes even years. The product can be reconstituted by adding a sterile diluent, and the resulting liquid injectable will have the same potency and sterility as the original formulation.

The qualification process for a lyophilizer can be categorized into three key stages: installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ). These stages ensure that the equipment is installed correctly onsite, works as intended, and produces high-quality commercial batches. At JHS, we start with a water or demonstration batch to obtain good vial conveyance and ensure a successful tech transfer. Once a lyophilizer enters commercial production, engineers perform continuous monitoring to maintain optimal performance and product quality.

Lyophilizers use vacuum pumps, cooling systems, and drying chambers to turn a liquid drug product into a cake-like powder. Manufacturers need full control over the temperature and pressure during the freeze-drying process to ensure quality and safety. Automatic loading and unloading systems also help maintain a product’s sterility.  

At its core, lyophilization is simply the physical process of freeze-drying a liquid into a solid. Therefore, improvements in the field of lyophilization are more about optimizing equipment, introducing automation, and making small process adjustments than discovering completely novel ways to freeze-dry a liquid. JHS will assist with customization of freeze drying cycle.

For example, using automated loading and unloading system (ALUS) is a reliable and streamlined solution. As another example, in-line lyophilizers allow for continuous processing that shortens batch times and reduces contamination risks.

When choosing a lyophilization service provider, pharma companies should consider their experience with complex formulations, ability to scale production, and adherence to cGMP and Annex 1 regulatory requirements.

JHS has the technical experience, capacity resources, and regulatory track record to become your trusted partner for lyophilized drug products. Learn more about our lyophilization capabilities here.