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Gene Therapy Vector Biosafety Evaluation Service

As a service provider in the development of gene therapies for rare diseases, our company focuses on the biosafety challenges associated with viral vector production and works to reduce the risk of viral contamination. We provide our customers with biosafety assays for bacteria, fungi, mycoplasma, and exogenous viruses on drug materials to ensure the identity, efficacy, purity, and safety of gene therapies developed for rare diseases.

Background

Viral vectors are a commonly used tool in molecular biology and are widely used as delivery systems in gene therapy for delivering genetic materials to cells that are normally difficult to transfect. The field of virus-based gene therapy is growing rapidly and has gained more interest following the regulatory approval of CAR-T and AAV-based gene therapies. This strategy offers the promise of new therapy development for rare diseases that lack effective treatment options.

In the development of virus-based gene therapies, it is important to conduct safety testing to ensure that viral vector products are free of detectable contaminants that could pose a risk to patients. To increase the likelihood of developing successful gene therapies, improved manufacturing and testing methods are necessary to enhance the biosafety of viral vectors, which can help to further accelerate the development of therapies that meet relevant regulatory requirements and expectations.

Biosafety Testing of Viral Vectors

Biosafety Testing Services for Viral Vectors

Our advanced gene therapy platform allows for the provision of characterization and safety assay services for gene therapy vectors to accelerate the commercialization of viral vector-based gene therapy products. We help our customers select the right biosafety assay to overcome some of the unique challenges of gene therapies. Our services include, but are not limited to:

  • Sterility testing
    We offer customers sterility testing to assess the bacterial or fungal burden of the product. We have established multiple analytical methods and protocols including ATP bioluminescence, isothermal micro-calorimetry, nucleic acid amplification, flow cytometry, and solid phase cytometry as alternatives to traditional assays for rapid sterility testing.
  • Mycoplasma testing
    Traditional detection of mycoplasma contamination by culture and cell indicator methods is time-consuming and prone to false positives. With sensitivity and turnaround time in mind, we offer rapid PCR-based real-time detection systems to provide results in a much shorter time frame. Our highly sensitive and specific method allows for the accurate measurement of hundreds of mycoplasma species.
  • Endotoxin testing
    We provide customers with endotoxin testing services through the rabbit pyrogen test and the Limulus amebocyte lysate (LAL) test. In addition to this, our researchers are working to establish the recombinant factor C (rFC) test for use as an alternative new generation of technology to detect endotoxin quantitatively.
  • Replication-competent virus(RCV) testing
    Although viral vectors are designed to be replication-deficient, spontaneous recombination events within the producing cells during vector manufacture can lead to the production of RCV, which poses a significant safety concern for gene therapy. We offer our customers RCV testing via Southern blotting or qPCR assays to ensure the biosafety of gene therapy products.

As gene therapy shows increasing promise, the need for innovative, effective, and safe viral vector manufacturing continues to grow. Our company is well-positioned to help customers address the biosafety challenges associated with viral vector manufacturing and provide sound solutions to mitigate holistic risk and reduce contamination incidents. If you are interested in our services, please feel free to contact us for more details.

Reference

  • Spunde, K.; et al. Recombinant viral vectors for therapeutic programming of tumour microenvironment: advantages and limitations. Biomedicines, 2022, 10(9): 2142.

All of our services and products are intended for preclinical research use only and cannot be used to diagnose, treat or manage patients.

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