Simple solutions are increasingly being integrated in the ever-changing bioprocessing environment. As methodologies improve throughout the protein production industry, tools must have the flexibility to adapt quickly to new workflow demands. With process analytical technology (PAT) continuing to bring significant improvements, innovative technologies that can evolve with industry methodologies are essential for bioprocess optimization. The choice of equipment and instrumentation has a great impact on the protein process workflow and on de-bottlenecking steps.
One example of integration of a simple solution is the use of microvolume instrumentation for quality-control testing in Diosynth Biotechnology’s protein processing facility. As the demand to reduce the cost of biotech drugs increases, there is a growing emphasis on how companies like Diosynth perform bioprocessing more effectively, including Quality by Design (QbD) and PAT initiatives.
Microvolume Quality Control
The implementation of microvolume UV testing at-line eliminates batch testing, greatly reducing processing time, and increasing efficiency. Microvolume UV analysis is performed using Thermo Scientific NanoDrop™ 8000 spectrophotometers. Each spectrophotometer measures multiple protein samples using a sample-retention system that requires small amounts (~2 µL) of protein sample. The system uses the inherent physical properties, namely surface tension, to hold samples in place during measurement, eliminating the need for cuvettes, capillaries, or other containment devices.
Optical pedestals hold and measure up to eight microvolume protein samples at a time. The removal of classic containment devices allows the path length between the optical pedestals to change during the measurement cycle. The ability to optimize path length results in an extensive dynamic range of possible protein concentrations that can be measured (e.g., 0.1 mg/mL to 120 mg/mL for HSA), essentially eliminating the need to perform time-consuming dilutions and the errors associated with preparing such dilutions (Figure 1).