Featured Articles
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Best Practices For Ensuring Quality In Biologic Products
New biologic therapies have new challenges in their packaging and delivery systems because of their complexities, higher stability risks, and larger sizes.
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Is It Ever Too Soon To Start Your Performance Testing Assessment?
Developing a safe and effective injectable combination product involves performing risk assessments, establishing a set of Critical Quality Attributes (CQAs), and performing design verification testing.
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Key Considerations For Selecting Fill/Finish Manufacturing Technologies
Obtaining information and proactively mapping out your fill/finish strategy early can de-risk an investment in equipment or processes, ensuring you meet your long-term needs.
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Mitigating Particulate Risk In Injectables
What are the sources of such particulates in injectables, and how should manufacturers apply the latest regulations to ensure best practice when producing sterile drug products?
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Moving From Vial Systems To Prefilled Syringes And Autoinjector Systems
Moving from vial systems to prefilled syringes and autoinjector systems requires patient and caregiver needs, drug product requirements, system components, and performance.
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Extractables And Leachables – Assessing Risk In A Complex Landscape
It is not surprising that there is still confusion on the extractable and leachable topic. Guidances, where available, do not give step by step instructions on testing.
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A Glass Package Designed Specifically for Pharmaceutical Use
A comprehensive solution for multiple glass quality issues that affect drug products is essential to avoid costly delays and drug product recalls, all while increasing patient safety.
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Selecting Container Closure Components: A Data-Driven Approach To CCI
Discover an efficient, data-driven process that employs innovative methods to accelerate the selection of a closure containment system that meets the requirements of the modern regulatory landscape.
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Reliable Components For The Lifecycle Of Your Injectable Drug Product
As drug products increase in complexity, become more specialized, and trend towards self-administration, it is more important than ever to have a reliable drug closure system.
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Trends In Drug Delivery: The Growth Of Cartridge Based Technology
As pharma companies evaluate the delivery systems for their drug product, there are several reasons why they may select a cartridge-based system compared to a pre-filled syringe or vial.