As part of the BioPhorum Technology Roadmapping Phorum, Project “RAVnS” is focused on Rapid methods for Adventitious Virus Detection and Sterility Assurance.
This project contributes to the goals of the BioPhorum 1st edition BioManufacturing Technology Roadmap to reduce production lead time by reducing product lot release times from weeks with current methods to days with innovative methods.
Team members consist of industry professionals from over 10 biopharmaceutical companies who are all interested in driving the adoption of potential solutions.
To collate information on current testing regimes and interest/activities in rapid innovative methods surveys were conducted. Questions included identifying the main point of dissatisfaction with current methods are, barriers to adoption, and what activities would be useful in driving adoption of regulatory compliant release testing. Because the expectation is that methods will continue to evolve, the survey purposely did not focus on technology platforms, but rather focused on generic points to consider for implementing new methods which will serve as the basis for today’s and future methods.
Participants of the survey were identified and selected by the group to be subject matter experts in this topic. Comments and results from the survey are presented herein.