Search results for " buffer"
Article
Development and Future of Protein A Chromatography Technology: Q&A with Jonathan Royce, Business Leader Chromatography Resins, Cytiva
Protein A chromatography columns are frequently too large, limiting the use of prepacked devices and consuming larger than necessary quantities of buffer.
Cytiva stated in a recent press rel…
Article
Process Chromatography: Continuous Optimization
“In addition to these opportunities to optimize performance, it is also important to look at improving the overall ecosystem around the chromatography process, by considering the buffers, cleaning age…
Article
The New World of Biopharmaceutical Manufacturing
Today, buffers are held in bioprocess containers and unit operations are connected with tubing. Chromatography columns can be disposable or can be replaced by single-use membrane adsorbers. In the pas…
Article
Evaluating E&L Studies for Single-Use Systems
Therefore, for these fill/finish processes, a dedicated simulation study, with the drug product buffer/placebo as extracting solution, may be sufficient to complete the extractables and leachables dat…
Article
Downstream Processing Continues to Worry CMOs
A majority of CMOs are considering:
• Use of high capacity resins
• In-line buffer dilution systems
• Single-use disposable tangential flow filtration (TFF) membranes
• Single use-prep…
Article
An Integrated Approach to Ensure the Viral Safety of Biotherapeutics
• Other raw materials including formulation buffers can be nanofiltered (20-nm pore size) as liquid solutions.
Building viral safety into a quality system
Effective virus r…
Article
Continuous Processing for the Production of Biopharmaceuticals
These gradients can be largely decreased by selecting an appropriate volume of surge material to act as a buffer going into the next unit operation (6). In addition, the length of different unit opera…
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Best Practices in Qualification of Single-Use Systems
Single-use buffer filtration system and storage bag application is common in downstream processes. Final drug-product sterile filtration and transfer using SUS has also being increasingly applied to f…
Article
Optimizing Cation-Exchange Chromatography with High-Throughput Process Development for mAb Purification
The issues with dilution have not been observed for buffers and salt containing aqueous solutions.
Optimizing binding capacity
The dynamic binding capacity is dependent upon several experiment…
Article
Re-use of Protein A Resin: Fouling and Economics
A typical Protein A chromatography process consists of five steps: pre-equilibration and equilibration of the column; capture of the mAbs from the harvest; wash step with the selective buffer to remov…