Flow Imaging Microscopy is currently recommended by the USP as an orthogonal analytical method for biopharmaceuticals. It has yet to be integrated into every drug development and testing laboratory however. Integrating new technologies upstream in the formulation development process continues to be an essential path for improving the safety and efficiency of the drug development. Once new methods and technologies are proven and accepted upstream, it's possible to pave the way for new technologies to be implemented downstream and beyond.
Hundreds of biopharmaceutical and pharmaceutical companies worldwide are now using the FlowCam to improve the quality, safety and stability of their formulations. Since most teams purchasing an analytical instrument for their lab want to read studies conducted by other scientists, we have gathered a collection of the top influential studies using the FlowCam to demonstrate how they are integrating Flow Imaging Microscopy into their research.
Launching this month, the FlowCam LO combines our patented flow imaging microscopy (FIM) technology with an embedded light obscuration particle counter. While LO is required for USP compliance, FIM gives you the ability to pinpoint and classify the types of particles in your sample in addition to revealing particles completely missed by LO alone. If your lab currently depends on LO, it's worth investigating how the FlowCam LO can bridge the gap to a new technology and allow you to reconcile your data with images.
Use the links below to access the full text of the papers summarized in the Top FlowCam Studies Guide to see how FIM is already being used to achieve a greater understanding of biopharmaceutical formulations.
Machine learning and statistical analyses for extracting and characterizing “fingerprints” of antibody aggregation at container interfaces from flow microscopy images
Biotechnology and Bioengineering (2020)
A.L. Daniels, C.P. Calderon, T.W. Randolph
University of Colorado Boulder
Forced degradation of cell-based medicinal products guided by flow imaging microscopy: Explorative studies with Jurkat cells
European Journal of Pharmaceutics and Biopharmaceutics (2021)
A.D. Grabarek, W. Jiskoot, A. Hawe, K. Pike-Overzet, T. Menzen
Extending the Limits: Oil Immersion Flow Microscopy
American Laboratory (2019)
C. Sieracki, Fluid Imaging Technologies
Deep Convolutional Neural Network Analysis of Flow Imaging Microscopy Data to Classify Subvisible Particles in Protein Formulations
Journal of Pharmaceutical Sciences (2017)
C.P. Calderon, A.L. Daniels, T.W. Randolph
Ursa Analytics, University of Colorado Boulder
Determination of the Porosity of PLGA Microparticles by Tracking Their Sedimentation Velocity Using a Flow Imaging Microscope (FlowCam)
Pharmaceutical Research (2017)
A.S. Sediq, S.K.D. Waasdorp, M.R. Nejadnik, M.M.C. van Beers, J. Meulenaar, R. Verrijk, W. Jiskoot
Leiden University, Dr. Reddy’s Laboratories Ltd.
Subvisible Particle Content, Formulation, and Dose of an Erythropoietin Peptide Mimetic Product are Associated with Severe Adverse Post-Marketing Events
Journal of Pharmaceutical Sciences (2016)
J. Kotarek, C. Stuart et al.
US Food & Drug Administration
Protein Aggregation and Particle Formation in Prefilled Glass Syringes
Pharmaceutical Biotechnology (2014)
A. Gerhardt, N.R. McGraw, D.K. Schwartz, J.S. Bee, J.F. Carpenter, T.W. Randolph
University of Colorado, MedImmune