Aseptic spray drying provides an alternative to lyophilization as an enabling stabilization technology for parenteral biologic formulations.
Parenteral formulations are increasingly capturing a bigger share of the pharmaceutical market, driven by the booming biologics sector. The production of these injectables is, nonetheless, complicated and requires specialized equipment and facilities. “The biggest challenge in aseptic processing is to maintain sterility,” says Sam de Costa, stabilization project manager at Nova Laboratories, “especially if the manufacturing process involves novel or complex steps.” He highlights that FDA, the European Medicines Agency (EMA), and the World Health Organization have laid out well-defined regulatory requirements for parenteral drug products. “The main focus is on ensuring product safety because parenteral preparations bypass the patient’s natural defense mechanisms,” de Costa explains. “Sterility assurance and control of pyrogens is, therefore, particularly important.”
According to de Costa, terminal sterilization is the preferred approach in drug manufacture. “Unfortunately, many drug substances, particularly biologics, cannot withstand exposure to the elevated temperatures or irradiation required as part of a terminal sterilization process,” he notes. “In such cases, aseptic manufacture is the only available option.” In this article, de Costa speaks to Pharmaceutical Technology about aseptic spray drying as an alternative option for stabilizing parenteral formulations.
See the complete article in: A. Siew, “Exploring the Use of Aseptic Spray Drying in the Manufacture of Biopharmaceutical Injectables,» Pharmaceutical Technology 40 (7) 2016. Spray.
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