Ompi
OMPI NEXA SYRINGES: THE IDEAL SOLUTION FOR THE MOST DEMANDING DRUGS Here, Alessandro Morandotti, Technical & Quality Assurance Front-End Manager, and Rob Swift, Product Manager, both of Ompi, introduce the Ompi Nexa Syringe, and describe in detail how its design fulfills the challenging quality requirements for prefilled syringes used for the storage and delivery of biological molecules. The origin of biotechnology and therapeutic biotech products can be traced to the discovery of DNA in 1953. Since that time, extensive research has explored the role of specific DNA segments or chains in biologic processes and diseases. The key dates are in 1972-1973 when scientists at Stanford University carried out the production and replication of recombinant DNA. The basis of this technology is to introduce a segment of DNA from one organism into the DNA of another host organism. One important application of this technology is to use simple organisms or cells to produce human protein that has therapeutic use as a drug. The first therapeutic product based on recombinant DNA technology was insulin, which the US FDA approved in 1982. Since then, human growth hormone and numerous additional drug products followed these new discoveries. One of the characteristics of the biotech drugs is the size and geometric complexity of the molecules. These specific aspects have as a consequence the relative instability of the product compared with traditional small-molecule drugs. As a result, the primary packaging materials used to store and administer therapeutic protein products play an important role. Therefore, bio-pharmaceutical manufacturers may require special properties for the packaging materials and for the interactions of the container system surfaces with the drug product formulation.
In many cases, bio-pharmaceutical companies utilise lyophilisation – freeze drying – to ensure the long-term stability of protein products. However, ongoing developments in formulation science are allowing more products to be introduced as liquids for patient convenience and advantage. When this is possible, drug product presentations in prefillable syringes or auto-injectors often are the preferred marketing choice.
THE OMPI NEXA SOLUTION Today it is common to refer to the syringes used for storing biotech drug as “Biotech Syringes”. The idea of identifying these goods is to highlight that behind these syringes there are specially developed manufacturing processes based on the key requirements for the syringes dedicated to biotech drug products. Thanks to the experience from working on different development projects involving drug products, Ompi decided to put together the different identified solutions and to offer a new syringe called Ompi Nexa Syringe (see Figure 1). This special glass primary packaging can be considered the ideal pharmaceutical packaging solution for biotech drugs. Its key elements are: • increased compatibility between drug and container • minimum risk of false rejects of filled syringes • improved auto-injector compatibility • superior gliding performance.
Figure 1: The Ompi Nexa Syringe. 40
Mr Alessandro Morandotti Technical & Quality Assurance Front-End Manager T: +39 049 9318111 F: +39 049 9366151 E: info@ompipharma.com Mr Rob Swift Product Manager T: +39 049 9318111 F: +39 049 9366151 E: info@ompipharma.com Ompi Via Molinella, 17 35017 Piombino Dese (PD) Italy www.ompipharma.com
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