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Rapid Adventitious Agent Testing for Fail-Fast Process Decision-Making

The aim of this project is to implement a nonPCR probe-based method for rapid adventitious agent testing as part of a fail-fast screening strategy of various process components to inform rapid process decisions thus reducing financial and supply risk
Categories
Drug substance
Assays
Project status
100% Completed

Solution

Performance Period: 10/15/2019 to 10/14/2021

While rare, adventitious agent (AA) contamination events are catastrophic. Current AA testing (AAT) coupled with reliance on contract research organizations give three to four weeks between sample submission and response for an actionable result. During this time, four or more weeks of produced material may need to be discarded and the contaminating AA will have proliferated and propagated downstream, compounding the decontamination problem.

We propose to use micelle-tagging electrophoresis (MTE) to supplement traditional AAT as part of a “fail-fast” strategy for AAT. This probe-based technology can be used to screen samples against a panel of 50-100 likely AAs, obtaining positive assay outcomes rapidly (< 1 hour) and with high likelihood, and informing rapid process decisions to reduce financial losses and drug supply disruption.

In agreement with Bristol-Myers Squibb priorities, we will implement MTE to screen raw materials, cell bank, and bulk culture samples against representative mycoplasma and virus probes. MTE will be validated against traditional AAT as practiced by Bristol-Myers Squibb. Two researchers will be trained at Carnegie Mellon/Bristol-Myers Squibb. Starting MRL is 4 based on the establishment of the MTE technique in the literature with complex biological samples; finish MRL is 5/6 based on the proposed initial validation work.

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Project Lead

Carnegie Mellon University

Carnegie Mellon University

Participating Organizations

Bristol-Myers Squibb

Bristol-Myers Squibb