West Introduces NovaPure® 3mL Cartridge Components and Features SmartDose® Gen. II 10mL Drug Delivery System at PDA Universe of Pre-filled Syringes and Injection Devices
"Our customers face a number of demands from increasing regulations and requirements, to evolving patient needs, to an ever-changing healthcare landscape. Our goal is to simplify their journey and work by their side to support them with products, services and solutions. We aim to speed their development and to help ensure a continuous supply to the market of important therapies which drive better patient outcomes," said Karen Flynn, Senior Vice President and Chief Commercial Officer, West. "The launch of our NovaPure 3mL Cartridge components line and the enhancements to our SmartDose platform are the first of many upcoming product launches and updates we'll be announcing in the coming months to address specific issues we know our customers are facing as they work to bring innovative, new injectable medicines to market."
The NovaPure 3mL Cartridge components expand the robust NovaPure product portfolio which currently includes stoppers and syringe plungers. NovaPure components embody West's highest quality standard for components, adhering to scientific, risk-mitigating Quality by Design (QbD) principles resulting in dimensional control and consistency, vision inspection and visible particulate control, and best-in class particle specification. The new components are specifically designed for 3mL cartridges often used in autoinjectors and other drug delivery devices. They incorporate West's premium quality enhancements: Westar® pharmaceutical wash and sterilization, FluroTec® barrier film, and a comprehensive data package, and are an ideal choice for sensitive biologic drugs coming to market.
West developed the SmartDose portfolio of devices to offer patients with chronic health conditions, who require medication injections, a reliable, convenient and easy-to-use method for home-based drug administration. The SmartDose Gen. II 10mL drug delivery system adheres to the patient's body, so patients can remain hands-free during the injection, which may range from minutes to hours. The Company has now completed the development work to enable up to 10mL of medication injection and is ready for commercialization.
The well-established scientific and regulatory expertise of West will be featured in the following educational presentations and poster sessions at the PDA PFS meeting:
Podium Presentations (
- Excipients Effects on Functionality of Glass and Polymer Based Pre-filled Syringes (
3:10pm CEST) – Liang Fang, Ph.D., Principal Research Scientist, West, will present as part of moderated Session 1B on Polymer Containers, to be held from 2:30pm-4:00pm CEST.
- A Science-Based Recommendation of Elastomer Components for Biologic Drugs (
5:05pm CEST) – Cathy Zhao, Director, Scientific Insights Lab, West, will join Session 2C on Novel Therapeutics, to be held from 4:45pm-6:00pm CEST.
- Evolving Component Technologies to Meet the Needs of Cartridge Delivery Applications (
5:25pm CEST) – Simon Cote, Director, Technical Customer Service, and Royce Brockett, Director of Product Management, Prefilled Systems & Delivery, West, will join Session 2A on Large Volume Injection, to be held from 4:45pm-6:00pm CEST.
Poster Presentation (
- Device Drive Technology Considerations for Large Volume Drug Delivery (West Booth, during all breaks) – Tim Allen, Program Director, Self-Injection Systems, West, will highlight research comparing the mechanisms, performances and other key considerations of several drive technologies for subcutaneous drug delivery for large volume (>2.25mL) wearable devices.
Training Workshop (
- All About Pre-Filled Syringe Systems – From
Initial Developmentto Final Fill Finish ( 9:00am CEST) – Christa Jansen-Otten, Director of Global Product Management, Prefilled Systems & Delivery, West, will join three other industry leaders for a two-day interactive overview of relevant practical aspects and trends of developing and processing pre-filled syringes, including regulatory requirements and health care practitioner and patient perspectives.
For more information on West's high-quality packaging technologies and drug delivery solutions, including product demonstrations, please visit booths #F44 and #F51 at the PDA PFS meeting or visit us online at www.westpharma.com.
Trademarks and registered trademarks are the property of West Pharmaceutical Services, Inc. and/or one of its subsidiaries, in the United States and other jurisdictions, unless noted otherwise.
FluroTec® technology is licensed from
Certain forward-looking statements are included in this press release. They use such words as "will," "new," "newly," "aim," "speed," "ensure," "enables," "upcoming," and other similar terminology. These statements reflect management's current expectations regarding future events and operating performance and speak only as of the date of this release. There is no certainty that actual results will be achieved in-line with current expectations or that the new NovaPure® 3mL Cartridge Components and SmartDose® Gen. II Drug Delivery Platform product offerings will achieve any particular result. These forward-looking statements involve a number of risks and uncertainties. The following are some of the factors that could cause our actual results to differ materially from those expressed in or underlying our forward-looking statements: customer decisions to move forward with our new product offerings, dependence on third-party suppliers and partners and the ability to meet development milestones with key customers. These important factors are not all inclusive. For a description of certain additional factors that could cause the Company's future results to differ from those expressed in any such forward-looking statements, see Item 1A, entitled "Risk Factors," in the Company's Annual Report on Form 10-K for the year ended
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Emily Denney, Global Communications, +1-610-594-3035, Emily.Denney@westpharma.com, or Catriona Kennedy, Global Communications, Europe, + 35-35-131-2448, Catriona.Kennedy@westpharma.com