BioPhorum’s Visual Inspection/Particulate Control resource page is primarily the vehicle through which we are making available our “Industry-wide standardized methodology and risk classification tool for particle classification in biopharmaceutical parenteral products”.
The Proof of Concept (PoC) version of our methodology, and associated tool, has been designed to meet an industry-wide need: a risk-based rationale for classifying particles.
Currently there is no clear guidance on how to classify visible particles in parenteral biopharmaceuticals. This has led to a range of practices which, in itself, is not an issue. However, there is no common, or scientifically-based approach underpinning current practice, potentially exposing biopharmaceutical manufacturers.
BioPhorum’s Visual Inspection/Particulate Control workstream has developed this methodology, using existing guidance, academic research and review papers, compiling these existing works and refining a range of risk factors to create a Proof of Concept methodology.
Despite the 2-year journey to reach this point, the team is already involved in the process of expanding the methodology, to focus on particulate investigations to extend its utility to address visible particulate issues with a more global and comprehensive perspective.
A number of resources have been used in the development of the team’s methodology and tool. The team is grateful for the work that has gone into these.
Bukofzer, S., Ayres, J., Chavez, A., Devera, M., Miller, J., Ross, D., … & Watson, R. (2015). Industry perspective on the medical risk of visible particles in injectable drug products. PDA journal of pharmaceutical science and technology, 69(1), 123-139. http://journal.pda.org/content/69/1/123.short
Langille, S. E. (2013). Particulate matter in injectable drug products. PDA journal of pharmaceutical science and technology, 67(3), 186-200. http://journal.pda.org/content/67/3/186.short