Posted on: 8th August 2018

At the latest Fill Finish meeting in Roche’s Hillsboro facility, member companies compared efforts to use technology to reduce release times.  Among many valuable discussions, their endeavours to adopt rapid sterility technologies in operations emerged as a clear collaboration opportunity.  The adoption of rapid sterility is a goal for a number of companies given the potential reduction of lead times on sterility testing by 50 per cent. At the moment, sterility testing can take a few weeks to return results, but the rapid technique can return results in seven days.

The challenge for the industry is the validation of the testing methods and the absence of standards against which to measure and establish success. These problems were considered by the leadership group and the development of a harmonized industry-wide approach was endorsed.  Certain representatives from the Fill Finish Rapid Micro team have already started to work with like minded individuals from the Drug Substance Microbial Control team on this and aligned with the In-Line Monitoring team in Technology Roadmapping to ensure they complimented their efforts to go beyond existing technologies.  As a result, the approval from the Fill Finish Leadership team means they can now push ahead with greater speed and confidence.

In many respects, this goal with rapid sterility technologies mirrors their well advanced work to make the adoption of autofluorescent active air sampling easier in Grade A environments and reduce the dependance on settle plates.  Both are about the industry agreeing on harmonized validation methods and giving us collective confidence to adopt existing rapid micro technology. As such, the group have a second mission which is to create a generic methodology for the adoption of new measurement technologies, based on these two cases.

Key parts of this generic approach will involve pooling knowledge, aligning on approach and finally testing with regulatory authorities.  On this last front the rapid micro teams are hopeful that they will be in a position to brief one agency on this and other microbial control work being developed in BioPhorum later this year.  Watch out for an update if and when this development happens.

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