Going beyond pharmacopeial requirements is essential for the quality and safety of raw materials.
Light scattering analysis combined with more rapid size exclusion chromatography improves protein characterization.
Suppliers see challenges to the adoption of single-use technologies for downstream processing as opportunities.
New test methods can provide improved quality and efficiency, but they must be validated to demonstrate equivalency.
Industry suppliers describe new technologies to facilitate downstream processing.
New human and plant-based expressions systems can enable faster product development and improve quality at potentially lower costs.
New approaches to vaccine production are targeting rapid supply for pandemic situations and broadly effective therapeutic treatments.
The approval and acceptance of monoclonal antibody biosimilars is necessary if the biosimilars market is to experience real growth.
Researchers are using current understanding of the lyophilization process to predict performance on many levels during both process development and manufacturing.