Search results for " concentration"
Article
Optimizing Cation-Exchange Chromatography with High-Throughput Process Development for mAb Purification
Using a DoE approach, different pH and NaCl concentrations were studied to determine the dynamic binding capacities at selected conditions. A mAb eluate from the Protein A capture step conditioned to …
Article
QbD and PAT in Upstream and Downstream Processing
O2 pressure, catalyst concentration, and pH are examples of critical parameters. It is important to note that mAbs are currently the leading area of biopharmaceutical research. One of the key paramete…
Article
Evaluating Surface Cleanliness Using a Risk-Based Approach
Laboratory results from total organic carbon (TOC) and conductivity rinse sample for an alkaline detergent along with determining visible residue limits using multiple concentrations, light intensity,…
Article
Improving Process-Scale Chromatography
In-line concentration solutions
A number of technologies have been introduced to help address the challenges associated with the preparation and storage of the large volumes of different buffers r…
Article
Implementation of Raw Material Control Strategies in the Manufacture of Single-Use Bioprocessing Containers
Glutamine was added to the medium to a final concentration of 6 mM.
Cell growth-based film test method
Duplicate 2-L test containers were constructed from the film to be tested and 200-mL Acti…
Article
Platform Approach Speeds Process Development
New CHO DG44 and CHO K1 host cell lines evaluated at BI and currently implemented into the development platform are showing potential for up to 11 g/L of final product concentrations for platform fed-…
Article
Design of Experiments for Analytical Method Development and Validation
DOE for method validation seeks to validate the analytical method for a range of concentrations so that changes in formulation or concentration will not require additional validation as they are chang…
Article
Overview of a scale-up of a cell-based influenza virus production process using ReadyToProcess equipment
The cells were grown to a cell concentration of approximately 3 × 106 cells/mL. The cells were subsequently detached from the microcarriers with trypsin and used to seed a 50 L microcarrier culture in…
Article
Downstream Processing for Cell-Based Therapies
The DSP activities for cell therapies are those unit operations and processes that arise after the cellular expansion stage and, depending on the therapy, can include harvesting, washing, cell concent…
Article
Addressing the Challenges in Downstream Processing Today and Tomorrow
The cost of the virus-retaining filter, which can approach that of the protein A resin, can be reduced by using prefilters or optimizing protein concentration, temperature, buffer composition, and sol…