Human cells, tissues, and cellular and tissue base products (HCT/Ps) are required to comply with the donor eligibility requirements as per 21 CFR part 1271 and applicable guidance documents to prevent the introduction, transmission, and spread of communicable diseases by HCT/P’s.
To ensure the safety, purity, and quality of both investigational and licensed biological products, adventitious agents testing, and clearance are mandated at various manufacturing stages (Title 21 CFR 610.1, 610.13, 21 CFR 312.23(a)(7)(i) and (iv).
Next-Generation Sequencing (NGS), or high-throughput sequencing, is a technology capable of massively parallel sequencing of nucleic acid sequences. Hence, this sequencing technique holds potential applications for comprehensive virus detection in biologics.
A critical step for the virus detection from cell and tissue highthroughput sequencing is efficient extraction of nucleic acids from adventitious agents and next-generation sequencing library preparation. Another critical step in detection of adventitious agents is to identify the reads from extraneous agents using bioinformatics.
This project seeks to evaluate the RNA extraction methods and next generation sequencing library preparation methods to detect RNA from adventitious agents from diverse sample matrices. In addition, we are aiming to evaluate and develop a bioinformatics workflow for efficient detection of these agents.
Source – FDA