EXTON, Pa., May 3, 2017 /PRNewswire/ -- West Pharmaceutical Services, Inc. (NYSE: WST), a global leader in innovative solutions for injectable drug administration, announced today that Fran DeGrazio, Vice President Scientific Affairs and Technical Services, and Diane Paskiet, Director, Scientific Affairs, are leading several workshops and offering presentations focused on West's expertise in the areas of safety and compatibility of injectable products, as well as providing commentary on updated industry guidance.
"Our pharmaceutical and biopharmaceutical partners require expertise in specialized testing, analysis, and regulatory support to ensure their therapies are brought to market safely and efficiently," said Karen A. Flynn, Senior Vice President & Chief Commercial Officer, West Pharmaceutical Services, Inc. "The sessions being led by West experts demonstrate our commitment to providing insights that not only benefit our customers, but also help achieve the highest standards of scientific rigor in containment and drug delivery."
In advance of the AAPS National Biotechnology Conference, Diane Paskiet moderated the following scientific and educational session:
- Preconference Workshop on Challenges and Patient Impact of Particles in Biologics
April 30, 8:00 a.m. – 6:00 p.m., San Diego, Calif.
Particles in parenteral products, especially in protein containment, remains a hot topic, even though it has been discussed for many years. This workshop provided a lively discussion addressing questions related to particle formation, characterization tools and standards, to name a few.
During the workshop, Fran DeGrazio presented a sub-session titled, Unique Considerations for Testing and Understanding Particle Loads from Primary Packaging Components.
DeGrazio and Paskiet will also participate in two important, upcoming U.S. Pharmacopeial Convention (USP) workshops:
- Modernization of USP Packaging Standards for Glass and Elastomeric Components
June 19-20, Rockville, Md.
June 20, 9:00 – 9:30 a.m. – <381> Elastomeric Components Used For Injectable Drug Products
Glass and elastomeric materials used in packaging systems must be shown to be suitable for their intended applications. To address these issues, USP is revising two existing USP-NF chapters <381> Elastomeric Closure for Injections and <660> Containers−Glass. Diane Paskiet will present on the proposed revisions to <381> Elastomeric Components Used for Injectable Drug Products Packaging/Delivery Systems and provide background for developing additional chapters: <1381> Evaluation of Elastomeric Components Used in Pharmaceutical Packaging/Delivery Systems, <382> Elastomeric Closure Functionality in Injectable Pharmaceutical Packaging/Delivery Systems and <1382> Assessment of Elastomeric Closure Functionality in Injectable Pharmaceutical Packaging/Delivery Systems.
- Control and Determination of Visible and Sub-Visible Particulate Matter in Biologics
June 26-27, Rockville, Md.
June 27, 8:30 a.m. – Particulate Matter in Biologics Originating from Packaging Components: Occurrence and Control Measures
Part of a session on "Manufacturing Control of Particulate Matter," this presentation will describe current particle measurement technologies and sample preparation techniques applicable to packaging components. Visible and sub-visible particles from primary and secondary packaging components will be discussed and case studies will illustrate outcomes of particle investigations and examples of quality control data.
Additionally, Paskiet will co-chair and DeGrazio will present this fall at a Parenteral Drug Association (PDA) workshop:
- 2017 PDA Container Closure, Devices and Delivery Systems: Compatibility and Material Safety Workshop
October 2-3, Washington, D.C.
October 3, 8:30 – 10:00 a.m. – Impact and Consideration of Pharmaceutical Packaging on Particulates
With the patient in mind, this workshop will focus on the most current and relevant topics in the world of container closures for device and delivery systems as it relates to material compatibility and safety. Fran DeGrazio will present this session on the impact of particulates on injectable drug packaging.
In addition to regularly presenting at industry events, Fran DeGrazio also serves on various committees, including the PMF Visible Particulate Task Force for the PDA. Diane Paskiet contributes expertise to the industry through her participation in the USP Package Storage and Distribution Expert Committee; Product Quality Research Institute Development Technical Committee and Leachable and Extractable Working Group; and PDA Interest Groups.
For more information on these upcoming presentations, West products and services, and technical expertise, please visit us online at www.westpharma.com.
West Pharmaceutical Services, Inc. is a leading manufacturer of packaging components and delivery systems for injectable drugs and healthcare products. Working by the side of its customers from concept to patient, West creates products that promote the efficiency, reliability and safety of the world's pharmaceutical drug supply. West is headquartered in Exton, Pennsylvania, and supports its customers from locations in North and South America, Europe, Asia and Australia. West's 2016 sales of $1.5 billion reflect the daily use of approximately 112 million of its components and devices, which are designed to improve the delivery of healthcare to patients around the world.
West and the diamond logo are registered trademarks of West Pharmaceutical Services, Inc., in the United States and other jurisdictions.
West Pharmaceutical Services, Inc.
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SOURCE West Pharmaceutical Services, Inc.