Newsletter | April 15, 2021

04.15.21 -- Generating A Fully Processed Antibody

Comparing Batch Versus Continuous Modes

Current state-of-the-art continuous manufacturing technologies are being developed and implemented to manufacture a wide variety of products including monoclonal antibodies, recombinant proteins, and other biological modalities. This case study compares the productivity of purifications running in batch versus continuous mode.

Addressing Process Characterization And Late-Phase Development

Drivers for process characterization and late phase development include improving process understanding, enhancing process robustness, and assurance that the process delivers consistent product quality within all proven acceptable ranges (PARs). Learn a stepwise approach for the definition and execution of process characterization to produce a monoclonal antibody while improving the efficiency and effectiveness of the process.

Generating A Fully Processed Antibody

The number of complex biopharmaceuticals in development continues to increase and includes classes of molecules that require multiple proteins to be expressed at differing ratios to produce the correct biopharmaceutical. The authors outline 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.