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Fran DeGrazio, Vice President, Global R&D, TCS and SPM, Pharmaceutical Packaging Systems, recently contributed a chapter on primary container components to Quality by Design for Biopharmaceutical Drug Product Development. The volume, which was released in April 2015, is the first comprehensive overview of QbD as it applies to nearly every aspect of biopharmaceutical development.
Fran co-authored the chapter, “Quality by Design for Primary Container Components,” with Lionel Vendrine of Genentech. The chapter covers stoppers, vials and prefilled syringe systems.
Editors Feroz Jameel, Susan Hershenson, Mansoor A. Khan and Sheryl Martin-Moe provide an authoritative, detailed and clear explanation of QbD principles and its applications/implications for the development and commercialization of biopharmaceutical drug product for the biotech and pharmaceutical industries. In 28 comprehensive chapters, the book defines key elements of QbD and examines how those elements are integrated into drug product development.
Offering insights on lessons learned as well as demonstrations of QbD principles in practice, Quality by Design for Biopharmaceutical Drug Product Development is an excellent resource for scientists and researchers interested in expanding their knowledge on QbD principles and uses in creating better drugs.
Quality by Design for Biopharmaceutical Drug Product Development was published by Springer Science + Busienss Media LLC, and is available for purchase here: http://www.springer.com/us/book/9781493923151
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.
Diane Paskiet, Director, Scientific Affairs, will present at two sessions during the <strong>2012 PDA Annual Meeting. The meeting will be held from April 16-18, 2012 at the JW Marriott Desert Ridge Resort in Phoenix, Arizona.</strong>
QbD, CQA, QTPP,FEA – what does it all mean? Quality by Design (QbD) can be confusing, but it really doesn’t have to be. QbD was designed to promote an understanding of the product and manufacturing process starting with product development. When designing and developing a product using QbD principles, manufacturers must define desired product performance and identify Critical Quality Attributes (CQAs). The product and process is then designed to meet those product attributes, which leads to understanding the impact of material attributes and process parameters on the CQAs and identification and control of sources of variability. As a result of this knowledge, a company can continually monitor and update its manufacturing process to assure consistent product quality.
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