Search results for "contamination"
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Remote Monitoring and Big Data Advance Upstream Automation
…nd schedule of the automated solutions; the potential for increased process operational complexity, contamination risks, batch characterization, process integration issues; infrastructure challenges;…
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The Importance of Process Intensification and PAT for Achieving Real-Time Release
Creativity and collaboration are required to overcome complex method development challenges.
By Kelvin H. Lee and Mark Lies
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Reimagining Affordable Biosimilars
Advances in preclinical development play a crucial role in reducing cost for developing biosimilars.
By Anurag S. Rathore, Narendra Chirmule, and Himanshu Malani
Drug development is …
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Strategizing for Rapid Changeovers in Biologics Manufacturing
Several activities must be performed in a facility to avoid any risk of cross-contamination between Product A and Product B, in particular via a thorough cleaning-in-place of all equipment surfaces in…
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Technology Innovations Improve Process Chromatography Performance
…eed for cleaning between batches, which allows for rapid switch over; eliminating the risk of cross-contamination between batches; and allowing for a smaller facility footprint, Beattie enumerates.
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Eliminating Residual Impurities Starts with a Strategic Plan
“The method must be sufficiently sensitive or cross-contamination can occur, which can be a safety issue, particularly with HCPs, which are known to have an immunogenic response at low levels,” he com…
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Good Manufacturing Practices: Challenges with Compliance
Finally, know the source of the material that is entering your facility, and ensure that the correct manufacturing procedures have been followed to avoid the risk of contamination. Biologic materials …
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Maximizing the Effectiveness of Upstream Bioprocessing Through the Combination of Lab Informatics and Instrumentation
The key benefits of this approach are reduced manufacturing facility footprint and upfront investment, faster changeover between batches, reduced risk of cross contamination, and greater flexibility i…
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Cell-Culture Advances Test Bioreactor Performance Models
Perfusion mode can also create additional risks of contamination due to the continuous removal of depleted media and introduction of fresh media, and these processes involve a significant increase in …
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Tools and Processes for Mature and Emerging Therapies
To control contamination threats during transfer and fill/finish steps for bulk, vial, and syringe filling, companies introduced improvements to existing technologies and processes such as restricted …