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Replication-Competent Virus Testing Services

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All products and services are For Research Use Only and CANNOT be used in the treatment or diagnosis of disease.

Replication-Competent Virus (RCV) and Replication-Competent Lentivirus (RCL) testing is a critical safety requirement in gene therapy development. These tests ensure that viral vectors used in gene therapies are free from replication-capable viruses, which is essential for patient safety and regulatory compliance. At Creative Biolabs, we provide comprehensive RCV/RCL testing services with state-of-the-art facilities and extensive expertise in viral vector safety assessment. Our testing services are designed to meet the stringent requirements of global regulatory authorities, including FDA, EMA, and NMPA. With our advanced testing platforms and experienced scientific team, we ensure reliable and accurate testing results to support your gene therapy development journey.

What is RCV/RCL Testing

Definition & Purpose

RCV/RCL testing encompasses sophisticated analytical methods designed to detect and quantify replication-competent viruses in gene therapy products. The testing process involves multiple complementary techniques, all working together to identify any virus particles that may have regained their ability to replicate independently.

Potential Risks

The presence of replication-competent viruses can lead to severe consequences:

  • Uncontrolled viral replication in patient tissues
  • Potential for insertional mutagenesis
  • Immune system complications
  • Risk of virus transmission to other tissues

Clinical Impact

Replication-competent viruses can cause serious clinical complications:

  • Systemic inflammatory responses
  • Oncogenic transformations
  • Adverse immune reactions
  • Potential for germline transmission

Testing Requirements

Regulatory authorities mandate comprehensive testing throughout development:

  • Master Viral Seed Stock testing
  • Working Viral Bank testing
  • End-of-production testing
  • Process validation samples

Safety Measures

Comprehensive safety measures include:

  • Multiple testing methods integration
  • Sensitive detection techniques
  • Validated analytical procedures
  • Extensive quality controls

Regulatory Framework

Testing must comply with strict guidelines:

  • FDA guidance for viral vector testing
  • EMA requirements for gene therapy
  • ICH safety guidelines
  • Regional regulatory requirements

What We Do

AAV Replication Competency Testing

Testing Methods

  • qPCR-based detection of wild-type AAV sequences
  • Cell-based assays for replication assessment
  • Capsid protein analysis
  • DNA sequence analysis
Parameter Specification
Sample Requirements ≥ 1×10¹³ vg/mL AAV vector
Sensitivity ≤ 10 copies/reaction

Testing Process

  1. Sample preparation and quality check
  2. Cell culture and infection
  3. Multiple rounds of amplification
  4. Detection and analysis
  5. Result verification and reporting

Lentivirus RCL Testing

Testing Methods

  • p24 ELISA assay
  • Vector genome detection
  • VSV-G envelope testing
  • Cell-based amplification assay
Parameter Specification
Sample Volume ≥ 5% of production lot
Detection Limit 1 RCL per 6×10⁸ TU

Compliance

  • FDA Guidance for Industry
  • EMA/CAT/GTWP/244869/2019
  • ICH Guidelines

Retrovirus Testing

Testing Methods

  • Marker rescue assays
  • S+L- focus forming assay
  • Extended S+/L- assay
  • PCR-based detection
Parameter Specification
Culture Period 5 passages minimum
Detection Sensitivity 1 RCR per 10⁶ cells

Customized Testing Protocols

Available Customizations

  • Vector-specific protocol development
  • Novel serotype testing
  • Modified capsid testing
  • Specialized detection methods

Development Process

  1. Initial consultation and requirements analysis
  2. Protocol design and optimization
  3. Method validation
  4. Standard operating procedure development
  5. Quality control implementation

Frequently Asked Questions

What types of samples are suitable for replication-competent virus testing services?

Our Replication-Competent Virus Testing Services are applicable to various types of samples, including:

  • Biological products such as vaccines, recombinant proteins, and monoclonal antibodies
  • Cell culture supernatants
  • Clinical samples such as blood, serum, and cerebrospinal fluid
  • Viral isolates and viral seed stocks
  • Non-standard or rare sample types, or complex biological matrices

What is the sensitivity of your replication-competent virus testing services?

The sensitivity of our replication-competent virus testing services depends on the specific detection method employed:

  • qPCR-based methods typically offer high sensitivity, capable of detecting viral genomes at concentrations as low as 10-100 copies/ml
  • Cell-based assays have slightly lower sensitivity, generally detecting infectious viral particles at levels of 1-10 PFU/ml or 1 TCID50/ml
  • Protein analysis methods have moderate sensitivity
  • DNA sequencing analysis depends on the sequencing depth, typically detecting low-abundance viral sequences at frequencies of 0.01%-1%

We select the most appropriate testing methods based on our clients' specific requirements, and we can combine multiple methods when necessary to achieve optimal detection performance. We continually validate and improve our testing methods to ensure the highest levels of sensitivity and reliability.

Can you detect multiple viruses simultaneously?

Yes, many of our detection methods can simultaneously detect multiple viruses:

  • qPCR-based methods can utilize multiplex primers and probes or melt curve analysis to differentiate various viruses
  • Cell-based assays can distinguish multiple viruses by employing different indicator cell lines or observing distinct cytopathic effects
  • High-throughput sequencing technologies enable the simultaneous analysis and identification of all viral sequences present in a sample

We can develop customized multiplex detection methods tailored to the target virus types provided by our clients, fulfilling the need to detect multiple viruses concurrently.

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