Search results for " contamination"

Article Remote Monitoring and Big Data Advance Upstream Automation
…and schedule of the automated solutions; the potential for increased process operational complexity, contamination risks, batch characterization, process integration issues; infrastructure challenges…

Article 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 …

Article 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 …

Article Strategizing for Rapid Changeovers in Biologics Manufacturing
Closed-system design and operation in and between unit operations also mitigates the potential for cross contamination, states Husain. Closed processing is essential because it provides a better respo…

Article Technology Innovations Improve Process Chromatography Performance
Among the issues discussed frequently are how one defines where a batch starts and ends and how one can minimize the impact of contamination when something inevitably goes wrong. “It’s relatively …

Article Eliminating Residual Impurities Starts with a Strategic Plan
Eliminating Residual Impurities Starts with a Strategic Plan Identifying the source, assessing the risk, and removing residual impurities requires a strategic approach. By Cynthia A. Ch…

Article 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 …

Article 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…

Article 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 …

Article 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 …

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