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Safety Determination of Lentiviral Vector Service

Creative Biolabs provides a comprehensive suite of viral vector services, including vector engineering, preclinical process development, scale-up production, and analytical development. Our goal is to promote viral vector-based gene therapy to clinical trials for a wide range of disease treatments. We have built a team of talented and motivated scientists and technicians to pursue our commitment.

Introduction of Lentiviral Vectors

Lentiviral vectors, a number of gene delivery systems, are derived from lentiviruses that play an important role in transferring targeted genes into specific cells in mammals. Scientists suggest that lentiviral vectors have met with great success, and many laboratories or companies have focused on designing suitable lentiviral vectors to investigate their potential in a wide spectrum of gene therapy applications. In general, lentiviral vectors are designed by replacing the genome of viruses with several marker genes or a series of targeted genes, and viral cis-acting sequences are linked to an expression regulatory domain of transgene. Meanwhile, pilot studies have evaluated the performance of different kinds of lentiviral vectors in most target tissues, including liver, breast, lung, and heart. Furthermore, many advances are also made in vector assessment that is dedicated to improving the safety and effectiveness of lentiviral vectors in gene transfer. Of note, a wide variety of preclinical models, such as animal models and disease models, have been established to reveal the therapeutic potential of novel lentiviral vectors.

Schematic of HIV-1 and Third Generation Lentiviral Packaging System. Figure 1. Schematic of HIV-1 and Third Generation Lentiviral Packaging System. (Shaw, 2014)

Safety Determination of Lentiviral Vector

Gene therapy has been regarded as an alternative approach for a wide collection of disease therapy. As a perfect gene transfer system, lentiviral vectors have been developed and widely used for expressing high levels of the transgene in specific cells. In order to consider clinical applications, lentiviral vectors must meet the strictest safety standards due to their virus natures. As a result, Creative Biolabs has established a panel of assays to evaluate the safety of various kinds of lentiviral vectors, such as HIV-1 based lentivirus vector evaluation assay and non-human lentivirus vectors evaluation assay.

In our HIV-1 platform, replication-competent lentivirus (RCL) has been detected by using a positive control. Moreover, the vector titer, the number of vectors, as well as the potential containment of a wide variety of animal hosts have also been assessed. Currently, we have successfully developed a number of detection systems for our clients to estimate the pharmacodynamics and biosafety of lentiviral vectors. As illustrated, a clinically applicable lentiviral vector has been established to assess the biosafety and efficacy of gene transfer into patient-derived hematopoietic stem-cells. The data indicate that this vector shows a beneficial safety profile both in vitro and in vivo.

 Safety Determination of Lentiviral Vector Service. Figure 2. Safety Determination of Lentiviral Vector Service.

As a reliable CRO company, Creative Biolabs is committed and proud to be part of this rewarding challenge by offering its support to the pre-clinical and commercial manufacture of your viral vectors. We are proud to partner with our clients on the journey of bringing novel lentiviral vectors to gene therapy applications. If you are interested in our services, please contact us for more details.


  1. Shaw, A.; et al. (2014). Design and Potential of Non-Integrating Lentiviral Vectors. Indian J Urol. 2(1): 14-35.

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