Featured Articles
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How To Address Challenges In Oncology Drug Containment
Drug product containment systems comprising Daikyo Crystal Zenith® cyclic olefin polymer (COP) vials, matched with NovaPure® stoppers, offer container closure integrity (CCI) performance that has been quantified for oxygen and carbon dioxide, and they have excellent system performance.
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Evaluate CCI Of Vial And Syringe Systems Over Time And Temperature
Combining techniques, such as Residual Seal Force, tracer gas analysis, and headspace analysis, enables a more complete and quantified measure of CCI for vial and syringe combinations.
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Comparing Vial Container Closure Systems
Examine a case study where two 20mm vial CCSs were compared using the DeltaCube™ Modeling Platform and experimentally show the link between prediction and real performance.
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The Largest LOE Event In US Pharma History
Ahead of the first biosimilar Humira product set to launch in 365 days, this article provides a comprehensive run-down of where biosimilar sponsors stand and the key issues ahead of market formation.
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Packaging/Delivery System Integrity And Self-Sealing Capacity Of Vial Systems
Review the scope and testing procedures required by General Chapter USP <382> Elastomeric Component Functional Suitability in Parenteral Product Packaging/Delivery Systems.
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Stopper Functionality – Key Considerations
When selecting the appropriate rubber stopper for any respective vial containment system, there are many aspects to consider regarding the properties of the elastomeric closure.
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Evaluation And Identification Of Subvisible Particulate Matter In Injections
Review the scopes of USP chapters <787> and <788>. Both chapters address injections and have the same regulatory requirements according to their nominal volumes for subvisible PM.
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Early Decisions To De-Risk The Transition To Combination Products
The injectable product development landscape is changing, and the pressure to accelerate timelines remains constant. What can you do to overcome all the uncertainty and risk?
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Key Considerations For Emerging Companies When Selecting Packaging Components
Recognizing the importance of packaging development and prioritizing its role in drug development early on can help proactively identify potential delays and overcome risks.
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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.