Developing and maintaining a current master plan for cleaning in multi-product facilities are crucial.
Careful selection of downstream processing conditions is a must.
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.
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.
Suppliers see challenges to the adoption of single-use technologies for downstream processing as opportunities.
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.