New Developments in Controlled Nucleation: Commercializing VERISEQ^® Nucleation Technology

Abstract

Freeze drying, which is also known as lyophilization, plays an important role in drug manufacturing by stabilizing delicate pharmaceutical and biological products. The overall efficiency and consistency of the entire process, as well as ensuring high quality of the products, largely depends on the nucleation temperature. Higher nucleation temperature (lower degree of supercooling) results in fewer ice nuclei and larger ice crystals forming larger-sized pores and pore networks, which in turn, enables higher sublimation rates, and hence shorter drying cycles, as well as reduced reconstitution times and improved finished product attributes.

A recently introduced VERISEQâ Nucleation, developed by Linde Gases in cooperation with IMA Life North America, is a cryogenic technology that enables control of the nucleation process by using a sterile ice fog, produced using liquid nitrogen and water vapor, and offers a new degree of control over freeze-drying process as well as the ability to develop more robust lyophilization cycles. This technology can be implemented on virtually any freeze-dryer from laboratory lyophilizers to commercial scale units, as well as aseptic and nonaseptic units, and new as well as retrofits—regardless of pressure rating. The technology is adaptable to both vial-based and bulk freeze-drying processes and helps mitigating a host of related issues leading to improved process parameters as well as enhanced product quality.