3Rs Safety Testing of Gene Therapy Vectors
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PureAVec paper now published. Contact us if you want to use the Puravec vector contaminant detection service for your vectors.
Analysis of HIV-1-Based Lentiviral Vector Particle Composition by PacBio Long-Read Nucleic Acid Sequencing | Human Gene Therapy
The World's First Human Cell-based Safety Evaluation Platform for Gene Therapy Products
As a scientific leader in genetic toxicology, TestAVec has developed the world’s first patented human stem cell (iPSc) based in vitro testing service to reduce genotoxic risk of gene therapy products.
Aiming to identify, reduce and eventually replace the use of animal models that can give biased oncogenic outreads, our ambition is to bolster confidence in gene therapy products and their application and accelerate the time taken for gene therapies to reach the clinic.
The Gene Therapy Challenge
One of the most significant challenges in gene therapy today is finding solutions to avoid the side effects of viral vectors used to deliver gene therapy products directly into the patients genome.
Integrating viral vectors may adversely impact product and patient safety due to random insertions into cancer genes and upregulation of these genes causing genotoxicity, mutagenesis and oncogenesis.
Current pre-clinical animal studies deliver varied and often unreliable overestimates of the risk of insertional mutagenesis and can potentially limit GT products reaching the market through lack of confidence.
The challenge for the industry is to mitigate these risks through optimising the safety profile of product candidates across the whole GT product manufacturing process.
The TestAVec Solution
As a CRO, we have developed the world’s first and patented human iPSc In Vitro Genotoxicity Testing Platform that generates bespoke profiles gene therapy (GT) vector genotoxicity using precursor biomarkers of vector mediated cancer hallmarks in human - induced pluripotent stem cells with applicability to multiple genetic disorders.
Our bespoke service enables vector screening and selection during product design and non-clinical testing.
We provide a safety by design service to increase confidence in GT products with clinically relevant go/no go in vitro assay read-outs informing product safety.
Our Ambition -
To make our platform widely available as the industry gold standard for non-clinical genotoxicity testing for gene therapy
Eventually replacing use of animals in some pre-clinical tests increasing reliable prediction of risk, and significantly reducing the costs of clinical testing.
The TestAVec Promise -
To make it possible asa CRO for all people suffering from genetic diseases to receive safety tested gene therapy products, also erasing the risk of genotoxic side effects of their therapy for their children and grandchildren.
"We believe we have developed a product which brings the TestAVec promise one step closer."
Mike Themis CSO, TestAVec Ltd
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