Search results for " methods" in Articles / App Notes
Article
Efficient Cleaning-In-Place Methods for Protein-Based Antibody Affinity Chromatography Resins
This whitepaper discusses cleaning of affinity resins intended for use in the purification of monoclonal antibodies and antibody fragments, for example, Fab fragments. Various cleaning strategies and …
Article
Handbook: Size Exclusion Chromatography Principles and Methods
This handbook describes the use of SEC for the purification and separation of biomolecules, with a focus on practical information for obtaining the best results. The media available, selection crite…
Article
HT Multi-Product Liquid Chromatography for Characterization of Monoclonal Antibodies
Ever-growing biotechnology pipelines have greatly increased demand for higher throughput, multi-product protein characterization methods. By taking a holistic approach to improving the analytical proc…
Article
A Platform Approach for the Identity Testing of Multi-Component Cell-Culture Media
The developed testing algorithm, which incorporates a combination of few relatively simple analytical methods such as osmolality, quantitation of glucose, and folic acid, provides specific identity co…
Article
Impurity Testing of Biologic Drug Products
In this roundtable discussion, industry experts share insights on the various methods used for purity and impurity analysis of therapeutic proteins.
Method development and validation
B…
Article
Adherent Cell Culture in Biopharmaceutical Applications: The Cell-Detachment Challenge
…fere with subsequent downstream processing steps that are unaffected by other alternative detachment methods. Therefore, detachment based on physical processes is certainly preferable to chemical tre…
Article
Microbiological Testing: Time is of the Essence
Traditional microbiological methods for sterility testing take 14 days from inoculation to detection and conclusive results, while culture-based methods for mycoplasma take 28 days. “The time to obtai…
Article
Host-Cell Protein Measurement and Control
…e used to improve the coverage or qualify the ELISA at risk and supplement the ELISA with orthogonal methods to characterize HCP process clearance (see Figure 2). Upon qualification and validation, H…
Article
PDA's Technical Report for Biotech Cleaning Validation
The report also considers the effect of degradation of the active on cleaning-validation practices and the widespread use of nonspecific methods, such as total organic carbon (TOC) and total protein, …
Article
Getting a Handle on Biopharma’s Most Critical Quality Attributes and Quality Control
Complexity—in particular, determining which product attributes are most crucial to product quality and patient safety—makes it challenging to apply quality-by-design (QbD) methods and process analytic…