MilliporeSigma Webinars
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Aseptic Process Sampling – A Regulatory Perspective
6/6/2017
This webinar discusses aseptic process sampling with a focus on the regulatory aspects.
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Product Aggregation In Bioprocessing: Origins, Prevention, And Removal
5/10/2017
The tendency for most biological products to self-associate and aggregate is a considerable challenge in process management and design, as aggregated product leads to safety concerns and lost yield.
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The Proof Is In The Pudding: Bacterial Retention Of Sterilizing Grade Membranes
3/27/2017
While the theoretical foundation of microbial retention by sterilizing grade membrane filters has not changed, advances in technology allow us to better understand the mechanisms and predict its performance.
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Excipient GMP: The Industry Journey From Guides To Standards
8/9/2016
During this webinar you will learn about the evolution of excipient GMP from guides to standards. A review of the current excipient GMP standards will be covered; specifically, it will include an explanation of what the EXCiPACT™ certification scheme is and how it includes a standard for excipients. Additionally, a review of the currently published NSF/IPEC/ANSI 363 GMP excipient standard will be covered. Lastly, we’ll discuss and review our approach for providing Emprove® documentation to support our customers.
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Guideline On Elemental Impurities: Challenges And Approaches For Implementation
8/9/2016
This webinar provides an overview of the current and upcoming regulatory requirements for elemental impurities, including recent developments in the pharmacopoeias (Ph. Eur. and USP). We will discuss their impact on drug product and pharmaceutical starting materials, focusing on APIs and excipients. The presentation will also outline risk-based approaches to assess and implement control strategies for elemental impurities, based on the latest regulatory requirements, and how this can be supported with dedicated documentation.
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Top Reasons To Outsource Your Early Biologic Development And Manufacturing To A CDMO
Small, mid-sized and large biotech companies discuss major hurdles they encountered and how a customer-centric CDMO partnership can help overcome these, dismissing the idea of one-size-fits-all.
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Process Impurities: Don’t Let PEI Or HCP Derail Your Biotherapy
Learn product characterization strategies to de-risk manufacturing and detect and characterize host cell proteins and polyethylenimine in mAb and cell and gene therapies.
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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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Viral Clearance - Something Went Wrong, What Do I Do Now?
Even the strongest study design may encounter issues with sufficient clearance to reach the target safety expectations. Learn how to troubleshoot these and manufacturing deviations that impact viral safety.
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Key Challenges When Selecting Media For Media Fill Tests
In this 10-minute quick learning tutorial, an expert from MilliporeSigma guides you through the main challenges for aseptic manufacturers when selecting a medium for media fill tests or aseptic process simulations.