Search results for " impurity" in Articles / App Notes
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 …