DEEPAK K. SHARMA,1 TERESA MARTIN,1 PETER OMA1
1ProteinSimple Technologies Inc., 115 Terence Matthews Cr., Ottawa, Ontario, Canada, K2M2B2
ABSTRACT:
Ongoing requirements for additional insight and cGMP consistent measurement has led to interest in new technologies which can be applied to the analysis of many different types of particle-containing fluids found throughout biotechnology. Flow Microscopy is a robust and versatile intelligent vision technology which is becoming the de facto standard for evaluating populations of micro-particles encountered during bio-formulation development, and is also finding acceptance in fill-finish and many other biotechnology applications. Features of Flow Microscopy which have resulted in its selection include the direct insight provided by imaging, superior sensitivity for near-transparent particles, ease of use, and flexibility in resolving and independently analyzing different particle types present in heterogeneous populations. As an example, the technology is used to quantify transparent protein aggregates of various morphologies which can coexist with silicone droplets, air bubbles, micelles, and a variety of foreign contaminants. The technique is used to detect, evaluate, classify, and independently enumerate the different particle types present. Beyond these current applications, the capabilities of Flow Microscopy make it a candidate for analyzing the different types of populations found elsewhere in biotechnology. This paper considers applications to both cell-containing and non-cell-containing fluids and provides Flow Microscopy results for representative sample types.
PRESENTED AT:
2009 BioProcess International Conference and Exhibit, Raleigh NC, USA
2009 ProteinSimple_MFI for Biotechnology