On-Demand Fill/Finish Webinars
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Selecting The Right Media For Your Aseptic Process Simulations
Media fill experts from MilliporeSigma provide an overview of what to consider when selecting media for aseptic process simulations, particularly regarding regulatory requirements and user requirement specification (URS).
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Challenges Associated With In-Use Simulated Administration Of Biologics
Explore some of the more challenging aspects surrounding in-use testing for parenteral delivery along with potential strategies to address these issues.
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Key Challenges When Selecting Media For Media Fill Tests
In this 10-minute quick learning tutorial, an expert will guide you through the main challenges for aseptic manufacturers when selecting a medium for media fill tests or aseptic process simulations.
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Managing Container Closure Related Complexities With Lyophilized Drug Products
Using a comprehensive approach to component selection mitigates risks to fill-finish and lyo processing. Explore key considerations for selecting lyophilization stoppers suitable for intended use.
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Addressing Key Challenges Of High Concentration Formulation Development
High concentration formulations often present challenges with regard to viscosity as well as potential changes in the behavior upon stability. Discover solutions to mitigate high viscosity.
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Regulatory, Cost Implications Of Switching Injectable Delivery Formats
Launching a large molecule in one format and then switching the delivery format often transpires as a lifecycle management strategy for cost efficiency, supply chain continuity, and patient benefit.
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A Data-Driven Approach To Container Closure Integrity
Gain confidence in your container closure system selection by utilizing a stepwise and data-driven approach to predicting and verifying container closure integrity.
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Selecting Container Closure Components: Extractables And Leachables
Primary packaging components require a thorough assessment to ensure safety and efficacy. Plan ahead and start your assessment early to mitigate your risks, delays, and out-of-pocket costs.
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EU Med Device Regulations: Ensuring Compliance For Integral Combination Products
Review the EU Medical Device Regulation (MDR) changes, specifically with respect to integral combination products, and examine the technical documentation packages supporting functionality and content.