Search results for " analyze"
Article
Impact of Manufacturing-Scale Freeze-Thaw Conditions on a mAb Solution
Samples from each test condition were taken after the first and third freeze/thaw cycle (1x and 3x), and analyzed by size-exclusion chromatography (SEC) (along with the control samples). The 3x freeze…
Article
Applications of Surface Plasmon Resonance for Detection of Bispecific Antibody Activity
During development and quality control, a range of analytical technologies are used to characterize biotherapeutic drugs, including methods to analyze their structural integrity and activity. Target/l…
Article
Optimizing Cation-Exchange Chromatography with High-Throughput Process Development for mAb Purification
Protein concentration in flowthrough fractions were analyzed by UV spectroscopy. DBC was found to increase with pH and NaCl concentration within the explored space, which correlated well with the SBC …
Article
Use of Multivariate Data Analysis in Bioprocessing
Of a variety of approaches, use of advanced sampling techniques, new sensor technologies, and analyzers has emerged as a topic of interest to the scientific community at large (2). Implementation of t…
Article
Concentrating Feed—an Applicable Approach to Improve Antibody Production
The protein charge profile was analyzed by imaged capillary isoelectric focusing (iCIEF) (ProteinSimple, Santa Clara, California). Antibody N-glycosylated forms were analyzed by PNGase F digestion, re…
Article
Design of Experiments for Analytical Method Development and Validation
• Analyze the study and determine settings and processing conditions that improve method precision and minimize bias errors. Document the design space of the method and associated limits of key factor…
Article
Putting Viral Clearance Capabilities to the Test
…ference with the ability of the indicator cells to be infected with the virus, it is not possible to analyze the entire volume for the presence of infectious virus,” he says. “There is always a lower…
Article
Evaluating Surface Cleanliness Using a Risk-Based Approach
A laboratory TOC analyzer (Sievers 900) was used for testing, and the TOC analyzer was standardized following the manufacturer’s recommendations with reference standards for sucrose and benzoquinone. …
Article
Evaluating E&L Studies for Single-Use Systems
These solutions were recirculated in each skid for a few hours up to seven days at normal process temperature, then sampled and analyzed by performing the different techniques. The reference solutions…
Article
Continued Process Verification for Biopharma Manufacturing
One of the main struggles to resolve when implementing CPV will be to determine the types and quantity of data to be captured and analyzed. CPV can err on the side of providing too little data to the …