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Article Understanding Validation and Technical Transfer, Part I
Biopharmaceuticals are often complex molecules, or mixtures of molecules, produced in biological systems and it is not always possible to fully characterize these products in the laboratory. Therefore…

Article What’s New in Upstream Technologies
Bench-scale automated cell culture system The scale-X carbo, from Univercells, is a bench-scale automated cell culture system for the expression and concentration of viral drug substance suited fo…

Article Bioprocessing Advances in Vaccine Manufacture
These advances include:  •Single-use systems (SUS)/disposable bioprocessing systems •Modular/transportable bioprocessing facilities •Novel expression systems/improved cell lines …

Article Navigating Data Integrity in the Modern Lab
… integrity in the analytical laboratory is crucial as companies move toward predominately electronic systems. While technology has helped make the preservation of data easier, it is just as important…

Article Single-use Bioreactors Have Reached the Big Time
Significant advances in film technologies, bioreactor designs, stirring mechanisms, and sensor systems have contributed to the increasing adoption of disposable reactors from the lab to production sca…

Article Tools for Continuous Bioprocessing Development
If the large-scale bioreactor is well characterized, a small-scale system can be used to replicate all of its operating conditions and potential variations. Proper scale down requires good simulation …

Article Remote Monitoring and Big Data Advance Upstream Automation
Specific examples include the adoption of single-use systems, particularly mobile systems designed for ballroom manufacturing and solutions that address the unique process control challenges associate…

Article Strategizing for Rapid Changeovers in Biologics Manufacturing
…design, equipment selection, operational considerations, and the use of appropriate plant management systems. Challenges on numerous fronts Challenges to rapid changeover come from many sou…

Article Successfully Moving Regulated Data to the Cloud
The document also highlights how organizations are increasingly moving to new, paperless environments, with much of their data now captured using electronic systems. Because of this change, many organ…

Article A Plastic Pipeline for Commercial Bioprocessing?
…egulatory approval, industry experts expect the percentage of biologic-based drugs produced by these systems to increase. The benefits of single-use technologies factor into increased adoption…

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