Director, Scientific Affairs
June 30, 2014
The following is an excerpt of an article that appears in the Summer 2014 edition (Vol. 6, Issue 2) of International Pharmaceutical Industry magazine. To read the complete article, which begins on page 92 of the issue, visit: http://issuu.com/mark123/docs/ipi_-_volume_6_issue_2_june_2014
Development of therapeutic proteins has been on the rise for a variety of disease conditions. The administration of parenteral biologics relies on interconnected attributes associated with compatibility of delivery components to the safety and efficacy of the final product. It is essential to characterise individual components in contact with a biologic to understand the risks to the delivery system as a whole and the effect on patient outcome. Selecting an appropriate delivery system for these therapies is critically important. The quality of the components within a delivery system also has a significant impact on the development efficiency and the time to market. There are unique regulatory expectations as well as physical and chemical aspects that need to be considered when choosing components for a delivery system. Adequate information on user needs is necessary to design a delivery device suitable for intended use. Quality considerations are important throughout each phase of the pharmaceutical lifecycle to assure fitness for intended use relevant to patients. Alignment of the delivery device with the biologic manufacture, storage and distribution processes is a key element for bringing a product to market.