Search results for " impurity"

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
An approach for establishing the CQAs of a mAb product by evaluating impact and uncertainty during risk assessment. A critical quality attribute (CQA) has been defined as “a physical, chemical, …

Article Analyzing Proteins Using SEC, MALS, and UHPLC
Light scattering analysis combined with more rapid size exclusion chromatography improves protein characterization. The characterization of proteins involves identification of their complex …

Article Novel Vaccine Technologies Meet the Need for Pandemic and Therapeutic Solutions
New approaches to vaccine production are targeting rapid supply for pandemic situations and broadly effective therapeutic treatments. Following the 2009 outbreak of the H1N1 pandem…

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
Techniques to enable the design and formulation of stable, protein-based therapeutics. In silico analysis and the evaluation of formulability, aided by new analytical tools such as hydrogen deut…

Article Comparing Protein A Resins for Monoclonal Antibody Purification
Summary These data demonstrate that the Resin 3 prototype has high capacity and reusability with stable step yield and impurity clearance (e.g., DNA, HCP) for more than 100 cycles. The engineered …

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 …

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