Gene Therapy Rare Disease

Avance Provides Biological Testing Services Supporting CGT Non-Clinical and Clinical Studies

We specialize in assay development, assay qualification or validation, and sample testing that complies with GLP and CGMP regulations.

Non-clinical and clinical studies that evaluate pharmacokinetic (ADME) and toxicology characteristics are essential to determine cellular and gene therapy (CGT) product safety and efficacy. Studies on gene vector and transgene biodistribution (BD), gene expression, protein expression, viral shedding, vector integration, and other areas are crucial for CGT preclinical and clinical research.

Avance Biosciences™ has more than three decades of experience providing biological testing services to support CGT development and manufacturing. Our unsurpassed expertise in real-time PCR, digital droplet PCR (ddPCR), next-generation sequencing (NGS), and many other molecular biology, cell biology, and microbiology tools, enables us to provide testing solutions that bolster our clients’ CGT programs. We specialize in assay development, assay qualification or validation, and sample testing that complies with GLP and CGMP regulations.

Finding a reliable testing partner is obviously essential to ensuring that a CGT program successfully launches. The Avance Biosciences™ team is adept at providing a wide range of testing services to aid in non-clinical studies and clinical trials during CGT development.

We look forward to meeting you at this year’s event!

If you need a specific assay to advance your drug development and/or manufacturing initiatives, please stop by our booth to discuss how we can help.

When you partner with Avance Biosciences™, you gain a CRO partner that is creative, collaborative and dedicated to sound science with a focus on the regulatory requirements our partners require. Contact our technical staff to discuss how we can support you in your project!

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