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Cell and Gene Therapy

Viral Vector, Oncolytic Virus, Stem Cell, CAR-T/TCR-T, CAR-NK, TIL, etc

Cell and gene therapies (CGT) are advanced biological products including viral vectors, oncolytic viruses, stem cells, CAR-T/TCR-T, CAR-NK, and tumor-infiltrating lymphocytes (TILs). Due to their unique mode of action (MOA), the manufacturing processes of these emerging biologics are more complex compared to traditional biologics and small molecule therapeutics. They require stringent GMP controls while experiencing rapid market growth. To ensure final product quality, developing science-driven, process-informed biosafety testing strategies that meet global regulatory standards is essential.

Biosafety Strategy for Cell and Gene Therapy

Cell and Gene Therapy

Detection of Replication Competent Virus

Lentiviral and adeno-associated viral (AAV) vectors are widely used in cell and gene therapies (CGT) production. Due to the risks of replication competent lentivirus (RCL) and replication-competent AAV (rcAAV) formation, rigorous safety control is required during production.

Biosafety Consideration of Replication Competent Lentivirus

Lentiviruses belong to the Reoviridae family, including a variety of pathogens (such as HIV, SIV, EIAV, etc.). The gene delivery system has been successfully applied to the production of genetically modified cell therapy products. These replication-incompetent vectors enable stable gene integration in dividing/non-dividing cells for long-term therapeutic expression but carry risks of Replication Competent Lentivirus (RCL) formation through plasmid recombination during production. RCL events may lead to insertional mutagenesis via uncontrolled viral replication and genomic integrations, necessitating rigorous safety testing despite LVs' advantages in cloning capacity and transduction efficiency.

Biosafety risks of Lentiviral vector in production and clinical

Therefore, regulatory requirements demand the detection and control of biosafety risks that may be brought by replication-competent lentiviruses during the production and clinical application of recombinant lentiviral vectors.

BRC solutions for Detection of Replication Competent Lentivirus

BRC Biotech provides customized development of new enveloped RCL detection.

RCL detection

Detection of Replication Competent Lentivirus in EOPC

Detection of Replication Competent Lentivirus in Supernatant
(C8166 co-culture and Quantitative Reverse Transcriptase Activity Assay)

Detection of Replication Competent Lentivirus in Transduced Cells
(C8166 co-culture and Quantitative Reverse Transcriptase Activity Assay)

Rapid RCL Detection for Transduced Cell

Integration Analysis with TLA-NGS

BRC Biotechnology has established and validated a replicating lentivirus detection using HIV-1 as a positive control. Additionally, we possess comprehensive capabilities for rapid RCL detection and clinical integration site analysis. For more information, please contact a BRC Biotechnology technical expert.

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