Downstream Process Development
Developing a high yield, scalable and cost efficient purification process is a key focus for each development program. MassBiologics has developed reliable processes for antibody purification as well as numerous other processes for other types of proteins. Staff is available to assist in developing an entire purification train from harvest to polishing - or with the incremental optimization of one or more steps. MassBiologics is focused on developing the most efficient process using industry standard and approved techniques and resins.
Viral inactivation and clearance steps will be developed to ensure that the process delivers safe and acceptable material for further processing into drug product.
Once a process has been developed, robustness studies can be performed to define acceptable process parameters. Further, characterization and profiling of impurities can lead to a deeper understanding of the process and serve as a benchmark during process scale-up activities.