Search results for " yield" in Articles / App Notes
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Advances in Engineering of Protein-Based APIs
“Merging these approaches enables a focused library design that can yield desired protein characteristics rapidly by eliminating the repeated rounds of screening required in a random library approach.…
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Biopharmaceutical Process Development: 2018 Lessons and 2019 Predictions
The biopharmaceutical industry continues to expand in new and exciting ways. What might be in store for 2019, and what important lessons should process developers take from 2018? Here, we look back …
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Optimizing Late-Stage and Commercial Cell-Culture Processes
Over the years, cell-culture processes have evolved to achieve optimum production yield and quality for both clinical development and commercial manufacturing.
Cell-culture evolution
Current c…
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Establishment of New Modern Plasma Fractionation Facilities in Asia
…but since that time, substantial improvements in the manufacturing processes have resulted in higher yields, a more diversified product range, and, most importantly, a significantly enhanced viral sa…
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Making the Move to Continuous Chromatography
“Data indicate that more than one column offers better efficiency, and greater yield of product per unit volume of chromatography resin per unit of time. That means that because the columns are smalle…
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Understanding Validation and Technical Transfer, Part I
Often, however, the reverse percentages are employed, resulting in wasted resources and yielding validation reports that do little to support the effectiveness of the processes they were intended to v…
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QbD Improves Cell-Culture Process Control
The cultivation step impacts both product yield and product quality (1).
Because there is a lack of techniques for real-time measurement of product attributes, quality assurance in biopharmaceu…
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Prepare for an FDA Bioburden Inspection
A best-practices response will not only help you be prepared for any upcoming FDA inspection, it may also yield valuable insights to help improve processes and procedures. Anastasia Lolas, former FDA …
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Evaluating Surface Cleanliness Using a Risk-Based Approach
Water-only cleaning at ambient to 80 oC was not sufficient to yield a visual clean and water-break free surface. Cleaning the coupons with water was successful in meeting the gravimetric testing of ar…
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Contract Manufacturing Through the Years
Developments in manufacturing technologies such as vastly improved yields for biologics, single-use systems, and continuous processing simultaneously require CDMOs to invest in new technologies while …