Search results for " analytical methods"
Article
Challenges in Analytical Method Development and Validation
The development and validation of analytical methods is crucial in drug development. While the biopharmaceutical industry has had success in reducing risk by incorporating analytical platform technolo…
Article
Establishing Acceptance Criteria for Analytical Methods
Little, PhD
To control the consistency and quality of pharmaceutical products, analytical methods must be developed to measure critical quality attributes (CQAs) of drug substance/drug product. An…
Article
Design of Experiments for Analytical Method Development and Validation
Recently, more attention has been placed on applying DOE to analytical methods. DOE for analytical methods has three major applications: method development for new methods or those that need improveme…
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Tackling Analytical Method Development for ADCs
Both small and large
As for any drug, analytical methods for the characterization of ADCs must be developed, and separate quality control (QC) tests must be established for lot release of the fina…
Article
Using Quality by Design to Develop Robust Chromatographic Methods
In 2010, the European Federation of Pharmaceutical Industries and Associations (EFPIA) Subteam on Analytical Methods introduced the concept of applying QbD principles to analytical methods (5) where t…
Article
HT Multi-Product Liquid Chromatography for Characterization of Monoclonal Antibodies
By taking a holistic approach to improving the analytical process, one can identify strategies to increase throughput and reduce development times and the costs of analytical methods. This article dis…
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
Analytical methods
BioPharm: What are the commonly used analytical methods for characterizing therapeutic proteins?
Tissot (SGS): The main document used by anyone characterizing a…
Article
PDA's Technical Report for Biotech Cleaning Validation
The appropriate analytical methods must be validated. Typically, validation involves principles from the International Conference on Harmonization's Q2 (R1) (4). Although degraded fragments of the act…
Article
Real-Time Characterization of Biotherapeutics and Comparability of Biosimilars
Real-Time Characterization of Biotherapeutics and Comparability of Biosimilars
A major advantage of SPR-based analysis is its ability to estimate the association and dissociation rate constants, an …