Search results for "buffer" in Articles / App Notes
Article
Tackling Analytical Method Development for ADCs
The challenge with this method, according to Kaur, is that the extinction coefficient (λmax) of the drug may change when conjugated to the antibody or in a different buffer. In addiiton, the drug and …
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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
bDtBPP was dissolved in 10% dimethyl sulfoxide (DMSO) in phosphate-buffered saline (PBS) buffer to make a stock solution with concentration 100 mg/L. ActiCHO SM cell-culture medium with 6 mM glutamine…
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Securing the Single-Use Supply Chain
…ems, and particularly for components and systems that already allow some interchangeability such as buffer bags and tubing connectors, will help speed up multisourcing, according to Hudson. On the ot…
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Optimizing Resin Performance with Disposable Chromatography Solutions
Since much of the time spent in chromatography unit operations is spent washing the column with buffer, increases in maximum achievable flow rate can have a large impact on overall productivity. Gener…
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Application of Quality by Design to Viral Safety
QbD in the Viral Safety of Raw Materials
A wide variety of biological raw materials can be used in a biopharmaceutical process, ranging from production cells to buffer components to excipients. Th…
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Using Quality by Design to Develop Robust Chromatographic Methods
For example, use of alternative buffer components, ion-pairing reagents, alternative column chemistries, and even completely different separation mechanisms can be applied.
Method evaluation
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Article
Concentration and Diafiltration of Cell-Derived, Live Influenza Virus Using 750 C Hollow Fiber Filter Cartridge
Cross flow filtration (CFF) is a technique extensively used in vaccine production and particularly in influenza vaccine manufacturing. In contrast to normal flow (dead-end) filtration (NFF), the fee…
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Outsourcing Trends in Biopharmaceutical Manufacturing
From expertly packing chromatography columns, to providing higher-quality liquid media and buffers at large-scale, suppliers with technical competence are taking on some of the industry’s most challen…
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Bioprocessing Advances in Vaccine Manufacture
This trend includes 54% considering high-capacity chromatography resins; 44%, single-use filters; 38%, automated buffer dilution systems; and 35%, single-use tangential flow filtration.Other advances …