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Subvisible particulates (defined as those in the 0.1-10 micron range) are a growing concern for injectable drug manufacturers. The particles may cause aggregation, which can impact the drug product and create a potential safety risk for the patient. To help ensure product quality, the U.S. Food and Drug Administration recommends that manufacturers gain a better understanding of how subvisible particles impact the drug.
Manufacturers should be aware of what types of subvisible particles can be found within the drug product, and should complete chemical characterization of those particles. Also, the origins of the particles should be known: is the particle from the environment, part of the manufacturing process, a reaction byproduct or coming from the container closure system?
As manufacturers begin to understand the subvisible particles affecting their product, they will gain a better understanding of the possible impact to the drug product and the patient, as well as the origin of the contamination.
New elastomer formulations made using cleaner and fewer ingredients have improved component quality. However, a deeper process understanding can help to mitigate risk during the manufacturing process. West has incorporated holistic Quality by Design (QbD) into some of its manufacturing process, and by doing so, is now achieving the highest possible process understanding. Such knowledge lends itself to increased process stability, which corresponds with an increase in quality for packaging components.
In 2012, West introduced a product line for elastomeric closures – NovaPure® components. Based on the QbD concept, the NovaPure brand was developed using a comprehensive quality target profile based on the needs of customers and patients. Critical quality attributes, determined with the end user in mind, have been built into the development process to help ensure quality, safety and efficacy throughout a drug product’s lifecycle. By following QbD principals, the West process provides a new, unrivaled level of component quality including a sub-visible particle specification supported by data and science-based decision making.
NovaPure® is a registered trademark of West Pharmaceutical Services, Inc., in the United States and other jurisdictions.
In recent years, there has been a shift in the pharmaceutical industry toward a Quality by Design (QbD) philosophy. To maximize a drug product’s safety and efficacy, pharmaceutical companies and their drug packaging and delivery partners are building new quality principles into the entire manufacturing process, from design and development to commercialization and administration. This scientific, risk-based QbD approach is fast becoming an essential strategy for bringing high-quality therapeutics to market quickly and efficiently.
The current pharmaceutical market has faced a variety of challenges, including increasing expectations for quality from end-users and regulatory agencies driven by concern for patient safety. While pharmaceutical companies are working to assure that new quality and compliance paradigms are met, a balance must be achieved between the reality of managing costs to provide a product that meets payer’s requirements and facilitating profitability in order to continue adequate business reinvestment.
Fran DeGrazio is an industry leader with over 35 years of experience in technical product development, quality, regulatory, marketing, and business strategy. Prior to retirement in 2022, DeGrazio was West Pharmaceutical Services’ Chief Scientific Officer and led a legacy of innovation through Quality by Design (QbD) and leading patient-centric elastomer components. Before her retirement I had the opportunity to discuss the development of 4040/40 gray formulation as the newest addition to West’s quality by design program the formula journey, the evolution and its importance in the marketplace.
<p><em>Component manufacturing process designed with Quality by Design principles meets the high-quality needs of pharmaceutical manufacturers and patients </em></p><p>West has introduced a new line of high-quality components under its NovaPure brand at the PDA Annual Meeting. Through a product development process that incorporates Quality by Design principles, NovaPure components, including serum and lyophilization stoppers and syringe plungers, will help to ensure the safety, efficacy and purity of injectable drug products.</p>
Sascha Karhöfer, Director Global ICS Platform at West, presented “New Elastomeric Formulation and Relevance of Quality by Design (QbD) in Primary Packaging” on March 19, 2013, at Pharma-Kongress: Production and Technique in Dusseldorf, Germany.
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