Search results for "automation"
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Supplier-Change Management for Drug-Product Manufacturers
Pharmaceutical change management processes extend to the materials and services employed to manufacture and test drug products, necessitating the need for an effective supplier-initiated change …
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Host cell protein quantitation using ELISA
Host cell proteins (HCPs) produced by cells during biologic manufacturing must be removed from the final product to protect patients. However, it’s challenging to detect HCP, and this step c…
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Simulation gets therapies to patients faster and smarter
Digital solutions are helping to decrease therapeutic time to market but remain challenging – learn how we work on overcoming that challenge!
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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…
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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…
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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…
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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…
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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…