Part One: Biologics and the Problem with Residual DNA
Part Two: Cell-Based Bioassays
Part Three: Micro-Flow Imaging
In this final post of our biologics blog series, bioassay scientists will construct a guide to the components of micro-flow imaging: imaging, counting and sorting, plus sample requirements.
Micro-Flow Imaging™, or MFI, couples microfluidics with digital microscopic imaging to determine particle size and concentration in biologics and injectables. The concept of Micro-Flow Imaging is very simple. If a particle moves through the flow cell, the particle is imaged and counted. The principles of flow cytometry, microfluidics, microscopy and digital imaging are combined into one instrument.
Sub-visible particles can be unintentionally present in parenterals as a byproduct of drug formulation and manufacturing. This type of analysis allows for the visual assessment of the types of particles present in a solution. Particles that can be present in biopharmaceutical preparations are silicone oil, air bubbles, protein aggregates, rubber pieces from closures and glass shards.