Search results for " techniques" in Articles / App Notes
Article
Selecting a Comprehensive Bioburden Reduction Plan
Personnel Training
BioPharm: Does operating personnel need specific training on bioburden reduction?
Souza: The manufacture of biologics requires operators trained in aseptic techniques, with …
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
Quality by Design and Extractable and Leachable Testing
These extracted chemicals are then identified by various analytical techniques, typically inductively coupled plasma mass spectrometry (ICP—MS), liquid chromatography-mass spectrometry (HPLC–MS), and …
Article
Ligand-Binding Assays and the Determination of Biosimilarity
LBA detection techniques
There are essentially two general methods for assessing ligand binding: ELISA (enzyme-linked immunosorbent assay)-type assays and kinetic binding assays. Classical ELISA a…
Article
What Drove Biopharma Development in 2014?
According to a 2014 CPhI report, more than 70 percent of pharma manufacturers are looking to increase quality and invest in technologies and techniques like QbD to achieve that goal. And while QbD may…
Article
DoE Provides Benefits, but Preparation Is Necessary
Consequently, reaping the benefits requires a significant commitment to DoE, including the training of researchers in study design and data-processing techniques.
The benefits of DoE
One of th…
Article
Analyzing Proteins Using SEC, MALS, and UHPLC
The characterization of proteins involves identification of their complex chemical and physical structures and requires the use of a range of analytical techniques. Size exclusion chromatography (SEC)…
Article
Q&As with Industry Leaders
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Eva Heldin, Section Manager of Antibody Application, R&D, Cytiva
Current Techniques and Challenges Presented in Scaling Between Bioreactors
Jeanne Linke Northrop, BioPharm I…
Article
Design of Experiments for Analytical Method Development and Validation
Quality risk management and statistical data analysis techniques should be used to examine the process of measurement and identify factors that may influence precision, accuracy, linearity, signal to …
Article
Determining Criticality, Part Two: DoE and Data-Driven Criticality
A practical roadmap in three parts that applies scientific knowledge, risk analysis, experimental data, and process monitoring throughout the three phases of the process validation lifecycle.
T…