Biodistribution Studies
Accurately assess vector and therapeutic cell distribution across tissues and time points using validated qPCR and ddPCR assays to support regulatory submissions for gene and cell therapies.
Rely on our expertise in large-scale biodistribution studies with robust assay design, high-throughput sample processing, and precise data generation aligned with GLP and FDA expectations.
Avance Biosciences has been providing qPCR biodistribution studies to support gene and cell therapy since the early 2000s, making us one of the most experienced labs in the world in assay design, validation (GLP or non-GLP), and study execution. Our extensive experience encompasses handling all types of tissues and blood samples from various animal models. We pride ourselves on having one of the best-designed workflows in the industry, meticulously structured to prevent potential contamination and ensure high-quality study results.
Biodistribution Services
BD of DNA viral vectors or transgenes: We offer GLP and non-GLP qPCR, ddPCR, and NGS testing services to support gene therapy biodistribution studies.
BD of RNA transgenes: Our RT-qPCR method utilizes RNA standard curves to evaluate the distribution of inserted genes that do not occur naturally in the tested animal.
BD of therapeutic cells: We provide GLP and non-GLP qPCR, ddPCR, and NGS testing services to support cellular therapy biodistribution studies.
Vector integration study: When required, we can aid our clients in developing and validating NGS-targeted sequencing methods that detect less than 50 copies of integrated events in 1 μg of host genomic DNA.
Gene editing site profiling: We offer quantitative NGS amplicon sequencing to support studies on the distribution and stability of therapeutic cells with edited genes.
Viral vector titer determination for dosing: To accurately determine viral vector titers at various doses, we have developed accurate and robust assays that utilize a proprietary viral-handling process that improves viral recovery.
Improved Biodistribution Studies with Avance Biosciences as Your Testing Partner
Our team has extensive experience with a wide variety of gene therapy vectors, including various viruses, therapeutic cells, microbial vectors, and plasmids. We are well-versed in working with tissues from numerous animal species. We excel at handling large numbers of samples while maintaining strict contamination control, consistently delivering high-quality study results within demanding timelines.
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Our Customers Say…
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
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
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