Featured Articles
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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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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.
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When Glass Vials Fail At Low Temps, Consider A Cyclic Olefin Polymer System
If the glass vial for a biologic drug experiences breakage, or does not maintain container closure integrity, a cyclic olefin polymer (i.e., Daikyo Crystal Zenith COP) system may be the solution.
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How Subcutaneous Delivery Can Help Patients Manage Chronic Conditions
Read more about how to improve your patients’ outcomes, avoid costly delays to launch, and provide a better return on investment.
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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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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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Reduce Costs And Improve Adherence For Self-Administration Of Biologics
There is a growing trend toward wearable injectors for bolus delivery in order to help improve adherence and lower the costs of therapy.
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Orphan Drugs – Small Batches That Demand Attention
Orphan drugs, or the drugs made in small batches for immediate medical attention, have the ability to be both life changing and lifesaving for patients suffering from a rare disease.