Search results for "analysis"
Article
Development of Purification for Challenging Fc-Fusion Proteins
Data analysis
Statistical analysis was carried out using Minitab software. Percent reduction was defined through the use of Equation 1:
[Eq. 1]
…
Article
Managing Risk in Raw Material Sourcing
To identify and assess risk, the company uses a documented risk-assessment process, facility audits, and a toolkit that includes such methods as failure modes and effect analysis, fishbone diagrams, a…
Article
Generating a Fully Processed Antibody
Development and selection of high-expressing FGE clonal cell line
Figure 2: Flow cytometry analysis of wild-type Chinese hamster ovary (CHO) cells and clones overexpressing formylglycine-…
Article
An Integrated Approach to Ensure the Viral Safety of Biotherapeutics
It should be conducted using a risk analysis tool suitable for viral risk (e.g., failure mode and effect analysis [FMEA], preliminary hazard analysis [PHA], and risk ranking and filtering [RRF]) with …
Article
Selecting a Comprehensive Bioburden Reduction Plan
Failure mode effect analysis (FMEA) and fishbone diagrams are useful tools to use.
Souza: Planning the design of a comprehensive bioburden reduction strategy should start with risk assessments for…
Article
Biopharma Advances Demand Specialized Expertise
In addition, 2D high-performance liquid chromatography (HPLC)/high-resolution mass spectrometry (MS) allows for analysis of samples incompatible with traditional MS. Reporter gene bioassays apply gene…
Article
Ensuring the Quality of Biologicals
reference standard to demonstrate system suitability, and users are requested to establish their own in-house reference preparation for glycan analysis.
Biosimilars
A similar biological or bio…
Article
Quality by Design and Extractable and Leachable Testing
Consider, for example, the analysis of risk posed by dosage form. A leached impurity in an inhalation or parenteral product poses a higher risk than the same impurity in an oral or topical product. Si…
Article
Implementation of Raw Material Control Strategies in the Manufacture of Single-Use Bioprocessing Containers
The compound bDtBPP (98% purity, as determined by HPLC analysis) was provided by Amgen Corp., CA, US. In this study, the monoclonal antibody-expressing CHO DG44 cell line was used under license from C…
Article
High-Throughput Process Development in an Historical Environment
About 100 delegates from 13 different countries joined the discussions on HTPD case studies in upstream, downstream, and formulations, as well as modeling, data analysis, and analytics. A new session …