Biologics: Subvisible Particles Characterization

The measurement and characterization of submicron size range (0.1 ~ 2 um) particles in biotherapeutic products has recently become viable with technical developments in instrumentation, and there have been discussion about including these measurements for comparability studies and other regulatory submissions.  However, the robustness of the technologies and their proper use is still being explored. Furthermore, there is no benchmark to which the results obtained from such measurements can be compared, to help guide the development scientist.  What is a reasonable number of sub micron particles to expect in protein therapeutics? How many particles of this size are present in products on the market or in the clinic?  The objectives of this subteam under the ALG, IQ Consortium are to:

1. Share analytical experience with the technologies to stimulate further technical and methodological developments in this area  
2. Publish (anonymized) data from various laboratories on drug product presentations to enable development scientists to benchmark their own programs.
3. Discuss the regulatory requirements in this area to aid development scientists in interpreting their data and inform risk assessment and regulatory strategy