Fran DeGrazio on Muck Rack

Fran DeGrazio

Philadelphia
As seen in: Drug Delivery Leader, Med Device Online, Pharma Manufacturing, Med-Tech Innovation, Pharmaceutical Online, Bioprocess Online, Outsourced Pharma, Cell & Gene, ONdrugDelivery, Biosimilar Development, Pharmaceutical Technology MX and
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Articles

Container Closure Integrity: A Risk-Based Approach To Ensure Drug Product Quality

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By Fran DeGrazio, T. Page McAndrew
| Drug Delivery Leader
By Fran DeGrazio and T. Page McAndrew, West Pharmaceutical Services, Inc. Qualification, and demonstration of fit-for-purpose, for a drug product vial/stopper/seal primary package system comprises many factors: protection, compatibility, safety, and performance. One of the subcategories is container closure integrity (CCI), which is the topic of this article. CCI is essential to protect the drug product through shelf life, and to demonstrate an integral system to regulatory agencies.
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Overcoming device component-related challenges and risks in prefilled syringe development

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By Reviewer Resources, Bettine Boltres, Fran DeGrazio
| PDA Journal of Pharmaceutical Science and Technology
Abstract Developing medicines to serve patients is a complex, highly regulated process in which multiple interdependent factors must be aligned. If one aspect is not thoroughly evaluated, it may adversely affect others and ultimately the final product, leading to delays, additional costs and, in the worst case, market access barriers.
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Understanding Risks Of Biologic Drugs And Injectable Drug-Device Combination Products

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By Fran DeGrazio
| Drug Delivery Leader
By Fran L DeGrazio, West Pharmaceutical Services, Inc. Background Growth in biologic drugs in the development pipeline of products has led to growth in the use of injectable drug-device combination products. Figure 1 shows this growth exhibited by drugs that have received FDA approval between 2011 - 2020 in the various package/delivery formats.
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