Search results for " automated"
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Commercial Production of Gene Therapies Using Suspension or Adherent Cell Lines
STRs offer several advantages: they are scalable and the principles by which to do so are well known, they offer precise and reproducible control of the culture conditions, and they are highly automat…
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Bind, Cut, Elute — Easy Affinity Tag and Protease Removal
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This blog post discusses automated methods for removing an affinity tag and the protease. The tag is cleaved while the protein is still bound to the affinity re…
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High-Quality Chromatography System Meets Predesigned DeltaV for Integrated Manufacturing
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Nearly 50% of the warning letters issued by the FDA cite 21 CFR data integrity violations. Implementing a distributed control system for facility-wide control of …
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Updating Viral Clearance for New Biologic Modalities
Viral clearance processes and guidance must evolve along with newer biotherapeutic modalities.
By Feliza Mirasol
Ensuring viral clearance (i.e., removal) in downstream purification has becom…
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Process Development: 2020 Reflections and 2021 Possibilities
The challenges posed by the COVID-19 pandemic in 2020 brought about many unprecedented lessons and promising developments in the biopharmaceutical industry. Last year in particular reenforced the ne…
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Reimagining Affordable Biosimilars
Multi-attribute methodology (MAM), liquid chromatography (LC), and capillary electrophoresis coupling techniques allow simultaneous measurement of multiple product and process impurities in an automat…
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Developing a Continuous Large-Scale Prefusion Cell Culture Process
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Perfusion processes enable continuous operation over extended periods of time by constantly providing fresh nutrients for the cells and simultaneously removing …
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Technology Innovations Improve Process Chromatography Performance
As technology matures, inefficiencies and process limitations in downstream process chromatography are improved.
By Feliza Mirasol
Selecting an appropriate separation technology fo…
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Protein A Fiber Chromatography from Research to Scale-up and Manufacturing of Monoclonal Antibodies
The new Protein A fiber chromatography format allows for quick purification of many samples because of its short cycle times. This makes the pre-packed, small-scale Protein A fiber unit a versatile …
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Gene Therapies Push Viral Vector Production
“We must bring robust, scalable, industrialized manufacturing processes as fast as possible (less manual and more automated processes) and GMP solutions for both small-scale and large-scale production…