Search results for "buffer"
Article
Using Single-Use Technologies in Downstream Processing
Some examples are filtration systems, buffer preparation systems, and sampling/dispensing systems. Key advantages of using single-use systems are speed of implementation, which is crucial for high-imp…
Poster
Optimization of concentration and diafiltration of a bovine γ-globulin solution
This application note describes the development of a cross flow filtration process for concentration of a bovine
γ-globulin solution.
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 …
Article
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…
Article
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…
Article
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…
Article
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…
Article
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…
Article
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
…
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…