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Technology Workshop Explores Adventitious Agent Detection

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More than 60 attendees from NIIMBL member organization gathered at the Merck facility in Kenilworth, NJ on October 22 for a technology workshop focused on Adventitious Agent (AA) detection.


The day-long workshop, titled Adventitious Agent Detection Methods & Controls, featured FDA and industry presentations, breakout discussions, poster session, and networking. Participants worked to assess gaps in AA detection and identify areas where new technologies, particularly those fostered through NIIMBL project calls, could address those challenges.


The program began with regulatory perspective from Arifa Khan from the FDA Center for Biologics Evaluation and Research, as she discussed next generation sequencing for AA testing. Presentations from Merck, MilliporeSigma, and Celgene addressed viral clearance and control, risk assessment of raw materials, and AA detection challenges in cell therapy, respectively.


Breakout sessions focused on four key topics: rapid detection of viral and mycoplasma contaminants, rapid testing of process raw materials, testing of cell banks, and unique AA challenges for cell therapies. Workshop participants plan to publish a report based on their discussions.


Technology Workshops are a valuable benefit of NIIMBL membership. The workshops provide a forum for technical discussions that help to spark ideas for future NIIMBL projects. Attendees also enjoy the opportunities to connect in person with other NIIMBL members to learn about each other’s capabilities. These discussions have served to inspire collaboration and partnerships amongst the NIIMBL community.


Materials from the workshop will soon be published in the technology section of the NIIMBL Community Portal on the Technology Workshop Output page (login is required). Members are encouraged to check back soon to view the materials. Members can also view materials from past workshops.


Additional workshops for 2019 are in the planning stages. Dates, locations, and topics will be announced soon. 

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