Injectable Drug Delivery Resources
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Prioritize Safety And Mitigate Risk In HPAPI Manufacturing
As highly potent active pharmaceutical ingredients become increasingly common across the industry, it is critical to work with partners who use a risk-based approach to ensure safety and quality.
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'Smart Devices' vs. 'Smart Design' In User-Centric Autoinjector Design
2/18/2020
Oval Medical has developed a novel Prefilled Primary Drug Container that resolves many drug compatibility and functionality issues associated with the use of traditional glass syringe and rubber plunger technologies.
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T Cell Cryopreservation: Comparing Rigid Polymer Vials And Flexible Bags
7/20/2023
This work evaluates the performance of rigid 50 mL COP vials as an alternative for cryogenic storage of T cells compared to existing flexible cryogenic bags. The results are timely given the emerging packaging requirements and larger batch sizes anticipated for allogeneic cell therapies under clinical development.
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The Growth Of Sterile Injectables
6/1/2023
Learn why partnering with a manufacturer capable of delivering flexible aseptic fill-finish solutions for any size production run is essential for delivering products to patients safely and efficiently.
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De-Risking Visible Particles Through Component Selection
Explore a summary of the FDA’s recent draft guidance “Inspection of Injectable Products for Visible Particulates” and how it applies to components.
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Plan For Your Extractables And Leachables Studies To Meet Submission Timelines
Demonstrating the compatibility of any material in contact with drug product throughout its lifecycle (manufacture, containment, and delivery) is a necessity for a regulatory submission.
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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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A Robust Extractables Data Package Helps Drive Patient Safety
10/1/2024
Complex drug product formulations are more common, so it is imperative to have a deeper knowledge of extractables to understand risks associated with potential interactions between packaging and product.
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Considerations In Development & Manufacturing Of Complex Injectables For Early Phase Studies
2/7/2022
A niche CDMO, with specialized technologies in complex injectable development, will have greater flexibility for successful manufacture of complex injectables in early phase development of therapeutic drugs.
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Solving For The Future Of Drug Delivery
7/16/2025
Next-gen therapeutics require equally advanced delivery systems—localized, personalized, and precise—to ensure efficacy, safety, and scalability. Delivery is now a central driver of innovation.