The inherent instability of biological drugs is a limitation that has a direct impact on the drug delivery sector. Therapeutic proteins must either be stored under special conditions or formulated to retain their efficacy from the time of manufacture until they are dispensed. Liquid protein drugs require refrigeration until dispensed – a distribution strategy referred to as the ‘Cold Chain’. Alternatively, proteins can be formulated as powders. These lyophilized proteins must be reconstituted prior to injection.
Lyophilized drugs are typically sold with reconstitution vial systems, or packaged in special injection devices that allow reconstitution to take place in the device prior to injection. Several innovative devices that package the drug powder and diluent in separate chambers within a single device, allowing the patient to reconstitute medication without the need for handling, measuring, and/or separate mixing steps, have enabled biological drug developers to create lyophilized drug products indicated for chronic conditions that can be self-administered safety and reliably. As biological drugs continue to grow in terms of therapeutics and total prescriptions, the impact of these specialty reconstitution systems will increase.
More information on the point-of-delivery reconstitution devices can be found in a comprehensive report, researched and prepared by Greystone Associates. The report examines the impact of reconstitution systems in nine key therapeutic segments.
About Greystone Associates
Greystone Associates (GreystoneAssociates.org) is a medical technology consulting firm focused on the areas of medical market strategy, product commercialization, venture development, and market research. We assist medical and healthcare market participants in achieving their business objectives through the creation of detailed development strategies, product commercialization programs, and comprehensive market and technology research and analysis. Our market research publications are designed, researched and written to provide timely and insightful information and data on focused market segments, with the aim of providing market participants with the essential knowledge to refine and execute their marketing plans and financial targets.