Gene therapy and cell therapy technologies promise to treat a wide variety of diseases, such as cancer, cystic fibrosis, and hemophilia. Equipped with advanced genomic analysis tools and years of experience of working with clients engaged in GMP manufacturing, pre-clinical safety study, and clinical trials, Avance Biosciences™ offers a series of services that support our clients’ efforts in gene therapy and cell therapy.
Gene therapy and cell therapy technologies promise to treat a wide variety of diseases, such as cancer, cystic fibrosis, and hemophilia. Equipped with advanced genomic analysis tools and years of experience of working with clients engaged in GMP manufacturing, pre-clinical safety study, and clinical trials, Avance Biosciences™ offers a series of services that support our clients’ efforts in gene therapy and cell therapy.
Non-clinical and clinical studies that evaluate pharmacokinetic (ADME) and toxicology characteristics are necessary to determine the safety and efficacy of CGT products. 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. Finding a reliable testing partner is obviously essential to ensuring that a CGT program successfully launches.
The Avance Biosciences™ team has more than three decades of experience providing biological testing services to support cell and gene therapy (CGT) development and manufacturing. Our expertise in real-time PCR, digital droplet PCR (ddPCR), next-generation sequencing (NGS), and many other molecular biology, cell biology, and microbiology tools enable 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.
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Studies on gene vector and transgene biodistribution, gene expression, protein expression, viral shedding, vector integration, and other areas are crucial for cell and gene therapy preclinical and clinical research. Avance Biosciences™ offers GLP compliant quantitative real-time PCR (qPCR) services to accurately assess the quantity of gene therapy vectors (DNA) in animal blood, CFS, and tissues for biodistribution studies. |
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Potency testing is an essential part of developing cellular and gene therapy (CGT) products. We use case-by-case approach to develop, qualify, or validate custom potency assays in accordance with current Good Manufacturing Practice (cGMP) regulations, ensuring that they comply with the necessary standards for GMP product release. |
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Since its discovery, CRISPR technology has been rapidly applied to biological drug development and gene and/or cell therapies . Avance Biosciences™ has adopted accurate and sensitive methods, such as using NGS amplicon sequencing, real-time PCR (qPCR), and ddPCR, to support our clients for evaluating indel profiles introduced by CRISPR or other gene editing tools, and for evaluating the percentage of cells with edited genes. |
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To ensure the safety of the CAR-T treatment, regulatory agencies require thorough characterization of the manufactured CAR T-Cells. Avance Biosciences™ offers customized qPCR and ddPCR solutions to help to determine the copy numbers of inserted or edited genes, replication competent lentivirus (RCL), and any other target of interest. In addition, we are experienced in supporting our clients in their preclinical biodistribution studies and preclinical/clinical pharmacokinetics studies. |
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Avance Biosciences™’ single-cell services for cell and gene therapies leverage the cutting-edge Mission Bio Tapestri® Platform to provide unparalleled insights into single-cell genomics. Avance is the “First-in-World” to GMP qualify an % transduction assay to characterize a lentiviral vector transduced drug product using the Mission Bio Tapestri® platform for single-cell characterization. |
Biodistribution
Potency
CRISPR Edited
CAR-T & Other
Our Customers Say…
Avance Biosciences™ (AB) has delivered the Sequencing data in a record time. Very impressive! We have benefited from AB’s hard work and are very grateful for that. AB team should feel proud of themselves. We thank AB team for their support and contributions, much appreciated.
Head of Quality Control, Microbial Manufacturing Service, California
Your team met the timelines we needed and did exceptional technical work. I will definitely make my management aware that Avance is a very capable partner for our bioanalytical needs.
Bioanalytical Senior Project Manager, California
My experience with Avance has been nothing but positive… I will keep sending work your way as I appreciate the attention your team provides and Avance’s creative technical team. See you soon.
Director Individualized Medicines, California
Avance has been the ideal partner in helping Mission Bio and our client,… be the first in the world to GMP qualify our single cell % transduction assay for a lentiviral gene therapy product. Excellent execution on the part of the Avance team. We look forward to more collaborations in the future.
Senior Director, Cell & Gene Therapy Business, California
From the preliminary conclusion of this work, we are already pleased to thank you for your customer-oriented approach and proactive communication in the course of this study. We are happy to see the profound difference in business mindset between your organization and our previous vendor…
Project Manager, Belgium
Thank you so much for successfully completing this important project for us on time. We are very satisfied with the final report and thank you for taking the extra effort to customize the report format. We will definitely use your lab for future projects.
Program Manager, California
It has been a pleasure working with you and your team. The project was carried out to the highest standard and delivered in a timely manner. I will definitely recommend Avance Biosciences™’ services to colleagues and friends.
Senior Scientist, Singapore
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!
