Scale-up using the same analytical and process equipment

Using Cell Metric® Plate imaging

To minimize unexpected behavior at scale, Fujifilm Diosynth Biotechnologies has made sure that the exact same analytical and process equipment are used for small scale and manufacturing scale. As a consequence, only small product-specific tweaks are usually required for new programs, once the “deltas” have been transferred to the manufacturing facility.

This structured approach to scale-up has been carefully choreographed by our dedicated specialist team, starting with streamlining of activities at small scale and culminating in a 200L-scale run performed on manufacturing equipment.

The same approach is taken for the analytical methods where method validation is begun in the process development lab and finished at the quality unit of the manufacturing facility. This data-rich approach to defining parameter space, even for early phase, sets the table for future process validation.

Integrated ambr™ technology is used for screening and early prediction.