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Replication-competent lentivirus (RCL) testing for cell therapy drug development

Validated molecular PCR assays to detect replication-competent lentivirus (RCL) in engineered cell therapy products, aligned with FDA and EMA expectations.

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Replication-competent lentivirus (RCL) testing

Replication-competent virus testing

Custom RCL/RCR assays

We provide qPCR and dPCR assays for sensitive detection of replication-competent virus (RCL for lentiviral vectors, RCR for retroviral vectors), ensuring the safety of engineered cell therapy products.

Sensitivity and reliability

High assay sensitivity is critical for RCL/RCR testing. Our workflows combine the precision of dPCR with validated qPCR, delivering reproducible and regulatory-compliant data at very low target concentrations.

Testing across samples

We perform sensitive molecular screening for RCL/RCR across a range of relevant clinical and preclinical matrices, including blood, biofluids, and engineered cell products, supporting robust safety evaluations.

Regulatory-aligned workflows

Using GLP/GCLP-validated methods aligned with FDA and EMA requirements, we generate regulatory-ready data for submissions in cell therapy development.

A comprehensive guide

RCL/RCR testing assays with PCR

RCL/RCR testing is challenging due to low target concentrations, the need for high analytical sensitivity/specificity, and stringent regulatory requirements. qPCR/dPCR provide reliable, reproducible evidence of RCL/RCR absence to support the development of advanced cell therapies.

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Replication-competent lentivirus (RCL)

Assay design and validation
Regulatory guidelines (EMA and FDA)
Challenges and best practices

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GLP and GCLP compliant laboratory

We are accredited for Good Laboratory Practice (GLP) by the Swedish Board for Accreditation and Conformity Assessment (SWEDAC) for qPCR, dPCR, and molecular biology. In addition, we are Good Clinical Laboratory Practice (GCLP) compliant to ensure the safe and reliable analysis of clinical samples.

Replication-competent lentivirus (RCL) testing at TATAA

Samples

Blood
Plasma
Serum

Analytes

Replication-associated elements

RCL testing for lentiviral vectors and cell products

RCL risk arises from recombination between packaging components during vector production. We design assays against lentiviral genes excluded from the transfer vector for a sensitive and specific detection of these unwanted elements.

Workflow and assay design

We start with matrix-appropriate nucleic-acid extraction and inhibitor mitigation, include internal controls, and establish LOD/LOQ using characterized positive materials. Full traceability is maintained through LIMS.

Regulatory submissions

FDA and EMA expect RCL testing for lentiviral vectors and modified cells, including testing of vector lots, producer cell banks, and the final drug product; additional patient monitoring may be protocol-driven. Our GLP/GCLP-validated methods (aligned to ICH principles) document specificity, sensitivity, precision, linearity, and robustness.