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Lyophilization, a process that freezes a solution then removes water by sublimation and desorption, is widely used in the pharmaceutical industry. It has become the preferred method for stabilizing bio-pharmaceuticals including monoclonal antibodies and proteins. The stability provided by lyophilization is critical for the success of blockbuster Lyophilized Drugs such as etanercept, infliximab and rituximab.
While the benefits of lyophilization are substantial, inspections have disclosed problems associated with the manufacture and control of these products. Many of the problems that have been identified are related to moisture specifications, potency, and stability.
The primary advantage of lyophilization is that it allows the preservation of biologically active compounds that are not thermally stable. In particular, peptides would not be suitable for use in therapeutic formulations without the help of lyophilization.
The market for lyophilized pharmaceuticals is predicted to develop as a result of rising regulatory approvals for a variety of lyophilized formulations intended to treat different illness conditions. For instance, the U.S. Food and Drug Administration (FDA) approved Tanzeum (albiglutide lyophilized for injection), for subcutaneous use, as a once-weekly therapy for type 2 diabetes in April 2014, according to GlaxoSmithKline plc. The Lyophilized Drugs Market is anticipated to reach US$ 322.9 billion in 2018 and is projected to grow at a CAGR of 7.1% from 2018 to 2026.
However, peptides may degrade during the lyophilization and storage processes or at the user stage due to physical stress and other factors. To minimize these problems, excipients are often added to the lyophilized product. These excipients, also known as cryoprotectants, protect the lyophilized molecule by replacing the molecular interactions that are normally provided by water molecules.
These interactions provide a strong mechanical barrier between the lyophilized molecule and other components of the formulation such as lipids or other proteins. They can reduce the reactivity of peptides with oxidizing agents. Consequently, a well-formulated Lyophilized Drugs will be stable and potent upon reconstitution and can be administered to the patient without significant loss of effectiveness.
To prevent degradation and other problems during the lyophilization process, it is essential to carefully control all steps of the process. This includes the selection of an appropriate lyophilization cycle, monitoring for contamination, and testing the stability of the final product. In some instances, the choice of a lyophilization cycle is based on a manufacturer’s marketing considerations rather than scientific data. Investigators should be sure to examine all relevant documentation and reports before choosing a lyophilization cycle for an investigation.
Moisture specification is a significant concern for Lyophilized Drugs. Inspectors have identified numerous instances where a manufacturer has failed to meet moisture specifications. These deficiencies were usually related to the filling line and/or the lyophilizer.
The NDi vacuum system for food packaging applications was launched by Leybold in July 2022. VAControl CAB controller has been integrated in this dry-running Novadry screw pump for smart controlling that is the basis of this system.
