Downstream biopharmaceutical purification unit operations, such as Tangential Flow Filtration (TFF) or ultrafiltration and diafiltration (UF/DF), often necessitate monitoring of total protein or nucleic content in the retentate, permeate or eluate.
The use of at-line or laboratory based full spectrum UV-VIS spectrometer is a common industrial practice for such purposes, to include variable pathlength and microvolume technologies. These approaches, however, require sampling, often involve moving parts (machine based), and significant operator training, which increase GMP risk and cost of ownership. Moreover, separate equipment is often required to enable in-line process monitoring and control capability, thereby substantially increasing capital costs as well as compliance and quality requirements.
In this article we explore a solution that offers in-line real-time monitoring across biopharmaceutical unit operations.