Injectable Drug Delivery Resources
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Navigating Regulatory Challenges In Oligonucleotide Therapeutics
12/12/2024
Oligonucleotide therapies offer precise treatments for genetic disorders and chronic diseases. They face unique regulatory challenges but hold great promise, especially when combined with FDA engagement.
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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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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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Overcoming Challenges In Cell And Gene Therapy Containment
Review the hurdles that can slow your time to market, including the challenges in packaging high-value therapies and solutions to help you mitigate risk and simplify the journey.
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Design Verification Testing Of Combination Products
7/12/2024
Developing a combination product and seeking a list of tests to complete design verification testing? Review the details for planning, design inputs, design outputs, and design verification.
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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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Contract Design And Development Vs. In-House: How To Find The Best Fit
3/21/2024
Explore the rationale behind opting for a contract development organization (CDO) to fulfill organizational requirements and underscore vital considerations for evaluating CDOs to ensure alignment with your project objectives.
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Utilizing Robotic Aseptic Filling Systems To Meet Industry Needs
5/19/2022
An aseptic filling and closing machine solution allowed Catalent to reliably process a wide range of both trayed and nested vials for their client product needs.
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PFAS In Medical Devices: Expert Insights On Frequently Asked Questions
1/2/2025
Watch to learn more about PFAs in medical devices, covering environmental concerns, health risks, testing, alternatives and management strategies with Shalene Thomas of Battelle.
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A Lifecycle Management Strategy For Sterile Injectables
12/9/2022
Gain insight into the benefits and challenges of transferring a therapeutic compound from one aseptic injectable format to another.