Ensuring the Safety of Vaccines and Biologics
Material Measurement Laboratory, Biomolecular Measurement Division
NIST only participates in the February and August reviews.
Biologic products such as monoclonal antibodies (mAbs), viral vaccines and some gene therapies are produced using cell lines and may become contaminated with adventitious agents during the manufacturing process via cell banks, raw materials, or the environment. These adventitious agents can potentially cause harm to recipients. Current testing methods are very time consuming and may not detect all types of viral adventitious agents. Next-generation sequencing offers the potential for nontargeted detection and rapid turnaround time. The Applied Genetics Group is investigating potential standards and methods for NGS detection of viral adventitious agents. Applicants with experience in molecular biology, qPCR, digital PCR, cell culture, viral propagation, bioinformatics or next-generation sequencing are encouraged to apply.