Search results for " capacity" in Articles / App Notes
Article
Risk Assessment and Mitigation in Biopharmaceutical Manufacturing
Some of the reasons leading to supply shortages could be increased market demand, poor product quality and/or GMP practice, increasing regulatory expectations, or limited or competing manufacturing ca…
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Advanced Technologies Facilitate Scale-up and Technology Transfer
…e because the modular nature of the system enables point-of-use increases or decreases in production capacity. “This ambitious project has extended the benefits for the most critical unit operation--…
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Optimization of Protein Expression in Escherichia Coli
The Lemo21(DE3) (Xbrane Biosciences) and Tuner (Novagen) strains confer the capacity to tune the expression of target proteins, and this may favor higher yields of better-quality protein. Lemo21(DE3) …
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Continuous Chromatography: Trends, Definitions and Approaches
…y enough, and that the addition of an extra column will only marginally improve chromatography media capacity utilization. Having said that, it is of paramount importance to realize that any multicol…
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Quality by Design and Extractable and Leachable Testing
Examples include the gravimetric leachable criteria for nonvolatile residues, residue on ignition, heavy metals, and buffering capacity outlined in United States Pharmacopeia (USP) Containers—Plastic…
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Implementation of Raw Material Control Strategies in the Manufacture of Single-Use Bioprocessing Containers
After seven days, the growth-promoting capacity of the respective incubated medium samples was assessed in triplicate 25-mL shake flask cultures. The cell inoculum was taken from maintenance cultures …
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High-Throughput Process Development in an Historical Environment
…SmithKline Vaccines, in which a high-throughput screening platform was developed to study adsorption capacity of aluminum-containing vaccines. Aluminum-containing salts are already established as imp…
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Challenges in Analytical Method Development and Validation
Depending on the intended use of the method, typical performance criteria (accuracy, reliability, specificity, sensitivity, range, robustness/maintenance, as well as speed and throughput capacity, but…
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Q&A with Industry Leader Konstantin Konstantinov, Genzyme Vice-President
More flexible management of manufacturing capacity according to market demand is also possible.
Furthermore, continuous processing facilitates quality control. For instance, many therapeutic…
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Monoclonal Antibodies Key to Unlocking the Biosimilars Market
The biosimilars market, many analysts believe, is on the cusp of significant growth. This growth in large part is due to the fact that numerous monoclonal antibody (mAb) biosimilars are expect…