Peer-Reviewed Study Proves Effectiveness of Crystal Zenith Cylic Olefin Container Closure Systems for Radiopharmaceuticals

US headquartered West (www.westpharma.com), a leading global manufacturer of components and systems for injectable drug delivery, has announced the first peer-reviewed data demonstrating the benefits of Daikyo Crystal Zenith vials for the synthesis of radiopharmaceutical products. The study, conducted by researchers from Massachusetts General Hospital’s Division of Nuclear Medicine and Molecular Imaging, compared the effectiveness of container closure systems made from the Daikyo Crystal Zenith cyclic olefin polymer to glass for peptide-labeled radiopharmaceuticals. The study results appear in the October 2013 issue of the journal Applied Radiation and Isotopes.

Peptide-based radiopharmaceuticals are used for the diagnosis and treatment of cancer and other therapeutic applications. Glass vials have traditionally been used as the container to enable the necessary chemical reaction that attaches radioisotopes to peptides. However, many peptides can easily be adsorbed by the walls of container closure systems (CCS), which means that costly radiopharmaceutical product is not fully recoverable after the reaction has occurred.

The study, “A container closure system that allows for greater recovery of radiolabeled peptide compared to the standard borosilicate glass system”, examined how much product adhered to Crystal Zenith vials compared to glass vials during the synthesis of peptide-labeled radiopharmaceuticals. Key findings from the study include the following:

· Container closure systems made of Crystal Zenith had less product adherence to vials compared to single-use glass vials;

· Crystal Zenith vials retained approximately 10 percent less of the radiopharmaceutical compared to glass vials; and

· Improved recovery of radiopharmaceuticals in Crystal Zenith vials was due in part to a lower adherence of the peptide.

“Over the past several years, we have seen tremendous interest in Crystal Zenith vials and syringes for drug packaging due to its ability to overcome issues of breakage, delamination and particulates associated with glass container closure systems,” said Vinod Vilivalam, Ph.D., Senior Director, Global Technical Marketing Daikyo-West Products, West. “This study is an important addition to the growing body of evidence showing Crystal Zenith container closure systems are an effective alternative to glass, especially in emerging areas of cell therapy and radiopharmaceuticals.”

PDA Europe: The Universe of Prefilled Syringes and Injection Devices

Experts from West will present at the upcoming Universe of Prefilled Syringes and Injection Devices conference organised by PDA Europe which will be held on November 5-6, 2013, in Basel, Switzerland. West’s representatives will report on the latest trends in the world of prefilled syringes and innovations in the field of self-injection devices.

West’s experts will host two sessions related to advances in self-injection:

· Next Generation Plungers for Enhanced Functionality: An Ideal Combination with Self-Injection Devices—Christa Jansen-Otten, Director Prefillable Syringe Platform, Europe, will discuss recent developments in plungers for improved and reliable performance. (Breakfast Session 2, November 6, 2013, 7.45 a.m.)

· West and Janssen Biotech Discuss a Novel Self-Injection Technology and Unique Partnership—Bart Burgess, Director, Business Development, Self-Injection Systems, West, and Peter Krulevitch, Engineering Director, Packaging, Devices & Delivery, Janssen Biotech, will present a case study of the development of an integrated drug delivery solution designed to ease self-injection. (Track 1, November 5, 2013, 4.45 p.m.)

Further, Christa Jansen-Otten will present on Material Composition, Manufacturing, Processing and Quality Aspects of Elastomers and Stoppers during the Hands on Training Course, Development of Prefilled Syringes, on November 7, 2013, at 1.30 pm. On the second day of the training course, November 8 at 3.30 pm, Christa and Horst Koller, Head of Technical and Quality Support Syringes at SCHOTT, will discuss supplier needs and supplier agreements and specifications.

West’s Nicolas Brandes, Business Development Manager, Daikyo Crystal Zenith, Europe, will present at the Pre-Conference Workshop Polymer as a Container Material for Prefilled Syringes on the topic “Daikyo Crystal Zenith: A Containment Alternative to Glass for the Pharmaceutical Industry” on November 4, 2013 at 4:55 pm.  

Additionally, West Vice President of Global Marketing for Pharmaceutical Packaging Systems Mike Schäfers will serve as co-moderator for the plenary session “Trends in Pharmaceutical Development and Manufacturing of Prefilled Syringes” taking place on November 5 from 11.30 a.m. until 1.15 p.m. The session highlights challenges and innovations in the rapidly growing prefilled syringe market.

“PDA Europe brings together the leading experts from the fast growing field of prefilled syringes,” said Schäfers, “We are very pleased to have the opportunity to participate in multiple sessions during the event, sharing our long-standing experience and expertise with components and systems for injectable drug administration.”

West also has a booth, #58, at the conference.