Yokogawa Fluid Imaging Technologies

Analytical techniques are crucial to protein biotherapeutics research, development, and manufacturing. It is important to understand diverse particle characterization techniques and how they relate to each other to ensure the safety and efficacy of drug products.

Use flow imaging microscopy, light obscuration, and dynamic light scattering for particle analysis in protein formulations.

Learn about the key benefits of adding automation to flow imaging microscopy and how these are implemented in ALH for FlowCam™

In this application note we show how flow imaging microscopy and FlowCam can help analyze particles in biotherapeutic samples. To demonstrate this ability, a simulated protein formulation consisting of silicone oil microdroplets spiked in a protein formulation was prepared and run on a FlowCam 8100 FIM instrument and analyzed with VisualSpreadsheet software.

In this white paper, we utilize FlowCam LO to obtain simultaneous Flow imaging Microscopy (FIM) and LO measurements of a single sample. The results demonstrate that LO can undersize or even completely fail to detect highly transparent particles such as ETFE and some protein aggregates that FIM easily detects. These results highlight the importance of pairing LO measurements with an orthogonal technique like FIM.

In this white paper, we demonstrate the analysis capabilities of FlowCam Nano for biotherapeutic formulation development. This study compares the results from FlowCam Nano with those from FlowCam 8100 when analyzing samples containing protein aggregates, sucrose particles, and bacteria. We also demonstrate the consistency of the particle concentration measurements with FlowCam Nano and how the instrument may also be used to determine relative particle concentrations in samples.

In our new white paper, we present detailed performance results for FlowCam's Artificial Intelligence software, VisualAI, using images of different protein aggregates including monoclonal and polyclonal antibodies and silicone oil that were obtained with multiple FlowCam 8100 instruments. We also demonstrate VisualAI’s effectiveness at measuring protein aggregate content in samples with known ratios of protein aggregates and silicone oil droplets.

In this case study we use a model protein formulation containing silicone oil microdroplets to show how flow imaging microscopy with FlowCam can help analyze particles in biotherapeutic samples.

Submicron Flow Imaging Microscopy with FlowCam Nano enables researchers to detect particulate sources like API aggregation and bacterial contamination that may lead to particle agglomeration if not addressed.

Light obscuration analysis is standard, but size data alone is not adequate to ensure safe and effective drugs. FlowCam LO combines light obscuration and flow imaging in a single instrument.