Outsourced Pharma Webinars
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The Crucial Role Of Apheresis In Cellular Therapies
1/8/2025
Gain valuable insights into the critical role of apheresis in sourcing high-quality cellular material for therapies.
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Exploring New And Improved Analytical Methods For Traditional And Unique Modalities
1/2/2025
Here, we review several challenges in biologics analysis and take a closer look at the advanced tools and methods being utilized to improve biophysical analysis reliability and efficiency.
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BioPhorum Raw Materials Risk Assessments
12/19/2024
Torsten Schaderdorf provides an in-depth exploration of current regulations related to Raw Materials Risk Assessment, highlighting the risk criteria and raw material scope outlined in the BioPhorum guidelines.
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Assemblies Are Not Particulate Free, Strategies For Risk Mitigation
12/19/2024
As single-use technologies gain prominence in critical applications, the scrutiny around particulate contamination intensifies due to its potential impact on drug product quality, safety, and patient outcomes.
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Transforming The Biopharma Supply Chain, eData Solutions For Agility And Manufacturing Efficiency
12/19/2024
Explore the role of eData in automating processes, enabling predictive analytics, improving supply chain resilience, and adopting standardized digital platforms in biopharma manufacturing.
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Managing Nitrite Impurities: Supplier-Manufacturer View
12/19/2024
Examine nitrites in excipients, nitrosamine risks, regulatory considerations, analytical controls, and a case study on mitigating risks in pharmaceutical manufacturing and storage.
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How Standardized Extractables Data Support E&L Risk Assessment
12/19/2024
Explore E&L evaluations, USP <665>, supplier-provided extractables data, and collaborative strategies to mitigate risks in Single-Use Systems for biopharmaceutical manufacturing processes.
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Evaluating USP 665 For Extractables Testing And Reducing Animal Testing For Biological Reactivity
12/19/2024
Explore evolving compendial methods, USP <665>, and transitioning to cell-based assays for extractables, leachables, and biological reactivity in single-use pharmaceutical manufacturing.
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Challenges Using Multiple Single-Use Systems Functionality Versus Extractables And Leachables
12/19/2024
Explore a risk assessment of extractables, evaluating single-use components, and addressing complexities in manufacturing processes, with a case study highlighting compatibility and patient safety concerns.
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Demystifying Large Scale Continuous Chromatography For Small Molecules
12/18/2024
Learn the fundamentals of developing a continuous chromatography process with Simulated Moving Bed (SMB) technology for small molecules, from gram-scale to multi-ton commercial production.