Regulatory Compliance Videos
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Single-Use Strategies For Uninterrupted Microbial Monitoring
2/22/2024
Watch as Emad Albarouki, a microbiology and sterility assurance specialist at Particle Measuring Systems, discusses the best practices for using BioCapt® Single-Use in continuous microbial active air monitoring.
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What Indications Can, And Will, mRNA Therapeutics Address?
12/5/2023
During our Bioprocess Online Live event, mRNA Update: Beyond Prophylactic Vaccines, we asked an audience of several hundred biopharma professionals what indications they’re addressing in mRNA therapeutic development. Here, our panelists address their responses and offer final thoughts on unfolding mRNA regulatory frameworks.
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Safety & CQAs: Do mRNA Therapeutic Regulators Know What They Want?
12/5/2023
In this segment, Combined Therapeutics CSO Thomas Van Cott, Ph.D. and Omega Therapeutics Executive Director, Process Development and Analytical Sciences Jeff Atkinson, Ph.D. address regulators’ likely safety and CQA concerns as well as audience questions regarding variable and changing RNA constructs.
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US GMP (21 CFR 820) Manufactured Oligos For Preclinical Research
10/18/2023
Learn why Custom cGMP Oligos should be considered to ensure oligo products meet the strict standards of MDx, LDTs, and preclinical research.
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How To Evaluate The Integrity Of Intravenous (IV) Bags
7/7/2023
Testing IV bags in compliance with Annex 1 guidelines requires a robust technology strategy to ensure product quality and patient safety. Learn how to deploy and validate technologies for IV bag CCI.
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An Efficient And Reliable Way To Digitalize Your Sterility And QC Testing Data
5/2/2023
Watch to learn about the M-Trace™ Electronic Test Record Software, your digital QC companion for trusted and efficient data recording that automizes and digitalizes your sterility and QC testing data.
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Simplifying Bioprocess Data Collection
2/17/2023
Centralized bioprocess data collection and aggregation lowers the risk of data loss during any manual retrieval process. Discover a solution that helps you meet data storage and reporting requirements.
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Lower Variability For Viral Titer Determination
1/11/2023
Learn about the benefits of ddPCR for ensuring precise and reproducible viral titers in the development of effective adeno-associated virus AAV-based gene therapies.
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3-Bucket Mopping System - Correct Mopping Protocol
12/9/2022
Discover the proper mopping techniques when using a 3-bucket system through an in-depth demonstration and detailed instructions.
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Impact Of Water Activity On OSD Product Potency, Purity, And Bioavailability
11/21/2022
Explore laser-based headspace analysis, the impact of USP<922> Water Activity on primary packing selection, and the impact of water activity on the potency, purity, and bioavailability of OSD products.