Join West’s Graham Reynolds as he presents the keynote at Pharmapack North America. Graham will present, “Understanding the regulations and safety concerns surrounding injectables to overcome inherent design challenges” on Wednesday, May 23, 2012 at 1:50 pm. The conference will be held at the Pennsylvania Convention Center, Philadelphia, PA on May 22-23.
Driven by trends towards increased use of delivery devices for self-administration, as well as the challenges created by modern biologic drugs, the need to evaluate and develop drug delivery systems in an integrated way is becoming more critical. This requires a thorough understanding of the needs and challenges of the patient, the drug, the drug container, and the delivery system, as well as all of the interfaces between these elements. In 2006 commercial lots of a drug product delivered by an auto-injector that contained a glass prefilled syringe were recalled in several European countries because of problems with slow or incomplete delivery of the drug. 1 There was a similar occurrence in 2009 in the United States when an auto-injector batch was recalled because of high force-to-fire values.2
The use of prefilled syringes and advanced delivery systems continues to grow as the convenience and safety benefits are shared by healthcare professionals and patients. A successful integrated system combines the needs of the patient and the drug product with a primary containment system that works effectively with a delivery device or system while maintaining the safety and efficacy of the drug product.
Glass issues such as breakage, delamination, leachables, and physical and chemical compatibility can affect the safety and efficacy of a pharmaceutical product. High-performance materials such as cyclic olefin polymers (COP) possess the valuable properties necessary to manufacture, store, protect and deliver drug products. When used in combination with a delivery device such as an auto-injector or electronic patch injector, COP vials and syringes help to provide a safe and effective primary containment system that can be successfully integrated with a delivery device to form a combination product that meets the challenges of high molecular weight biologic applications.
This presentation will give a general overview of some of these specific trends, and highlight the growing importance of combination products as a means to address the challenges of modern drugs, and the increasing prevalence of patients and caregivers when it comes to the treatment of chronic conditions. The presentation will discuss the science behind the development of novel integrated delivery systems, including the SmartDose® electronic patch injector platform technology, Daikyo Crystal Zenith® containment solutions, as well as practical examples of the benefits of early partnerships between drug and delivery system manufacturers that may help to not only improve understanding of end-user needs through human factors testing, but also mitigate risk and improve time to market.
About the presenter;
As Vice President, Marketing and Innovation at West Pharmaceutical Services, Inc., Graham Reynolds leads initiatives and develops strategies for growth of West’s Delivery Systems business, including the acquisition and development of new technologies that enhance the West portfolio. His activities include working to understand market and customer needs, with a focus on Integrated Drug Delivery Systems for injectable products, including prefillable syringes, self-injection systems, and various safety and administration systems. He can be reached at 610-594-2935 or Graham.Reynolds@westpharma.com.
Daikyo Crystal Zenith® is a registered trademark of Daikyo Seiko, Ltd.
Daikyo Crystal Zenith® technology is licensed from Daikyo Seiko, Ltd., a subsidiary of West Pharmaceutical Services, Inc. West markets SmartDose® as a multi-component system only. Final assembly of the prefilled component is completed by the pharmaceutical company.