Search results for " concentration" in Articles / App Notes
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,…
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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…
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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…
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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…
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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…
Article
The Importance of Partnering for Bioanalytical Studies
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Bose (Emery Pharma): Bioanalytical studies, which are designed to provide estimates for concentration of drugs and biologics in pre-clinical and clinic studies of the therapeutic molecule or …