Search results for "automation" in Articles / App Notes
Article
How to Use Multiwell Plates With Manual Operation
During process development, aspects like robustness, scalability, and GMP production come into play. FDA initiatives such as quality by design (QbD) put demands on better process understan…
Article
Top Process Development Trends for 2022 and a Look into 2023
FDA approved 37 drugs in 2022, within the normal range for the past decade or so. The European Medicines Agency (EMA) was even more successful—approving a record 55 therapies. More than half of thes…
Article
Report from the 12th Plasma Product Biotechnology Forum
…n Australia and Germany using optimized manufacturing processes and the latest technology with high automation. Important to note, is that the validation of the program is designed to achieve flexibi…
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Connected Inline Conditioning for Better Process Efficiency
In this study, we integrated an inline conditioning (IC) system that served as a buffer preparation skid with chromatography and filtration systems. This automated the buffer preparation p…
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Implementing Inline Conditioning to Advance Process Intensification
Buffer preparation is still a highly manual activity that often requires a lot of resources due to the large number and overall volume of buffers. With inline conditioning buffers can be prep…
Article
A Stepwise Approach to a Digital Transformation in Biopharma
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An interview on “smart” manufacturing—a paradigm shift towards digital transformation for improved safety and quality, optimized performance, and increased complianc…
Article
Cell-free Expression Systems Pose Cell Culture Alternative
Cell-free expression is promising in preclinical applications, but still presents challenges to scale up for commercial production.
Feliza Mirasol
Among the challenges in upstrea…
Article
Commercial Production of Gene Therapies Using Suspension or Adherent Cell Lines
This article will explore the traditional path from the laboratory to the clinic and how the fixed-bed technology provides an alternative solution to meet commercial demands.
By Alex Chatel and …
Article
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…
Article
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 …