Lyophilization: technology meets an increasing trend
More and more of today’s (and tomorrow’s) drugs are biotech drugs, complex and often highly sensitive molecules. External factors such as oxygen, sunlight, and pH values can negatively affect biotech products, leaving marketers looking for innovative ways to protect and preserve these important compounds until they can be administered to patients.
Lyophilization: an ancient technology applied today
Lyophilization (freeze-drying) , a concept that can be traced back to ninth-century Asia, often provides a solution to these challenges. Lyophilization, the process of freeze-drying injectable drugs, stabilizes compounds so they can be reconstituted just prior to administration. The lyophilization process can protect biological activity, extend shelf life, and even increase dosing precision. In recent years, more than 30% of parenteral Food and Drug Administration (FDA) approvals were for lyophilized drugs, and estimates predict that soon more than half of all injectable drugs will require lyophilization.
The basic process of lyophilization has not changed for hundreds of years; rather it’s been adapted for today’s uses in the pharma industry. A dissolved substance is frozen in its final package (vial, syringe, or cartridge) at a low temperature (for example, -60 C˚) the exact temperature gradients so called “annealing cycles” are determined for each individual compound . In step 2 (primary drying) the water or diluent is then extracted via vacuum, resulting in a porous, dry “lyo cake”. There is a final drying step to remove residual unfrozen water molecules. The process usually takes about 2 days, depending on the compound and the drug delivery system. Once lyophilized, products typically will remain stable for 2 or 3 years, assuming proper storage, vs just a few days for the same drug in liquid form.
With lyophilization outsourcing expertise is a must
Lyophilized drugs can be extremely complex formulations that demand specific expertise in manufacturing. Because formulation determines the duration of the freeze-drying cycle, working with a partner experienced in the optimization of lyophilization cycles is critical. Vetter offers decades of expertise in the lyophilization of complex, highly sensitive molecules. Vetter’s expert group of specialists works with customers to develop lyophilization cycles tailored to optimize efficiency yield and reduce residual moisture for each individual product. It’s a process that can begin during a product’s clinical development to support an optimized cycle and fine-tuned for commercial manufacturing.
A product’s delivery system is another important aspect of a lyophilization strategy. Vials are often an efficient packaging option, but they do add both administration time and overfill costs into the equation. Vetter’s dual-chamber technologies, the Vetter Lyo-Ject® syringe and V-LK® cartridge, offer a packaging alternative to vials that’s both suited for lyophilization and user friendly. Vetter can work with you to either launch your lyophilized product in a dual-chamber system or to transition your existing product from a vial as part of a lifecycle management plan.
With Vetter, you’re getting the expertise and innovation to keep your product part of a growing trend.
Food and Drug Administration (FDA)
The Food and Drug Administration (FDA) is an agency within the U.S. Department of Health and Human Services. The FDA is responsible for the approval of new pharmaceutical products for sale in the U.S. and performs audits at the companies participating in the manufacture of pharmaceuticals to ensure that they comply with regulations.