Next Generation Sequencing Test Bed

NIIMBL will invest in additional infrastructure to support the NGS test bed, including sequencing platforms and automation, to increase comfort with the technology and alleviate reluctance to include in regulatory filings.

Industry Need

The biopharmaceutical industry needs the ability to rapidly develop and release sterile medicines, such as small molecules, large molecules, and vaccines to patients to prepare for or respond to coronavirus.
A significant bottleneck is release of formulated drug product, which includes testing for adventitious agent (AA) clearance to ensure safety and sterility to patients.
Current tests to confirm AA clearance take 20 days or more to complete, which can have a dramatic impact on drug supply and outcomes for sick patients. Traditional methods include the in vitro test (14-28 days; untargeted) and PCR- based assays (1 day; targeted).

Solution

Next Generation Sequencing (NGS) can be used to identify and quantify nucleic acid sequences from all potential adventitious agents and is fast compared to cell-based assays. NIIMBL has initiated a program of work to demonstrate and facilitate adoption of NGS methods for AA testing. In this project, NIIMBL will invest in additional infrastructure to support the NGS test bed, including sequencing platforms and automation to demonstrate NGS more rapidly and robustly for AA testing.

Outcomes and Impacts

Increase industry and community familiarity with NGS by demonstrating NGS comparability with traditional methods as a faster release assay for vaccines and therapeutics

Help improve the release time of live-saving vaccines and therapeutics in response to coronavirus

Updates, Related Publications, and Deliverables

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Project Lead

NIIMBL