Newsletter | September 18, 2021

09.18.21 -- Efficiency And Effectiveness In Biopharmaceutical Development

Standardizing Process Characterization And Late-Phase Development

Learn an approach for process characterization to produce a monoclonal antibody, specifically at the drug substance biomanufacturing step, to improve efficiency and effectiveness.

Generating A Fully Processed Antibody

Discover cell-line development and process scale-up for an antibody program where the antibody requires additional processing by a site-specific enzyme for correct functionality.

Process Development: Ensuring A Consistent, High-Quality Biologic

Gain insights on risk mitigation, the differences between innovator and biosimilar drug product process development, and what to expect from a partner during the process development phase.

Comparing Batch Versus Continuous Modes

This case study compares the productivity of purifications running in batch versus continuous mode. Both Protein A capture resins demonstrated increased productivity with lower buffer volume in continuous mode.