Search results for " impurities"
Article
Optimizing Resin Performance with Disposable Chromatography Solutions
Although the initial uptake of single-use chromatography solutions has been relatively slow, an increased need for higher-capacity resins and the demand for smaller batches has made disposable chrom…
Article
Application of Quality by Design to Viral Safety
A quality-by-design approach defines a range of potential viral contaminants of source materials and can be used to effectively achieve viral clearance.
Oct 1, 2014
BioPharm International
…
Article
Defining Critical Quality Attributes for Monoclonal Antibody Therapeutic Products
“This characterization should include the determination of physicochemical and immunochemical properties, biological activity, purity, impurities, and quantity of the mAb, in line with ICH Q6B guideli…
Article
Analyzing Proteins Using SEC, MALS, and UHPLC
…molecular weight (MW) species, and the formation of degradation products, such as protein clips, and impurities. Today, SEC is predominantly used to measure aggregation, because the determination of …
Article
Novel Vaccine Technologies Meet the Need for Pandemic and Therapeutic Solutions
Furthermore, the use of bioreactors ensures a closed, sterile, controlled environment, and thus the risk of potential impurities is reduced. As a result, Novartis’ Flucelvax vaccine does not contain a…
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…
Article
Predicting Progress in Protein Aggregation
It can also be used for larger proteins (hundreds of kilodaltons) and protein mixtures, and the presence of certain protein impurities is tolerated. The most important recent advances in this technolo…
Article
Comparing Protein A Resins for Monoclonal Antibody Purification
A prototype Protein A resin is evaluated for purification performance, reusability, and cost performance.
With greater economic pressure on monoclonal antibody (mAb) production for therapeutic …
Article
Supplier-Change Management for Drug-Product Manufacturers
Pharmaceutical change management processes extend to the materials and services employed to manufacture and test drug products, necessitating the need for an effective supplier-initiated change …