Biodistribution Studies
Our Expertise
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.
What We Offer
Testing Service
Description
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.
Most Experienced Team
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.
Gene Vectors
Animal Species
Sample type
Adeno-Associated Virus (AAV)
Mouse
Tissues/Organs
Adenovirus (Adv)
Rat
Urine
Vaccinia Virus
Non-Human Primate
Feces
Newcastle Disease Virus
Rabbit
Blood (plasma, serum, PBMC)
Poxvirus
Pig
Saliva
Myxoma Virus
Canine
Semen
Epstein-Barr Virus
Tumor
Plasmid
Cerebral fluid
Human cells
Salmonella S. Typhi ZH9
sgRNA/mRNA/LNP
Key Features
Extraction Method Development
At Avance Biosciences, significant emphasis is placed on the development of nucleic acid extraction methods to ensure the efficient recovery of targets from tissues and biofluids. We often achieve an extraction recovery rate exceeding 50% for a wide range of samples. Custom extraction methods are designed and validated as needed, especially for difficult-to-extract vectors such as vaccinia and poxvirus
DNA Biodistribution Assay
At Avance Biosciences, we design and validate highly sensitive assays capable of quantifying as few as 50 copies of a vector gene in 1 microgram of animal DNA. To ensure accuracy and reliability, samples are tested in triplicate wells, with the third well spiked with a known positive sample to evaluate the PCR inhibition effect.
RNA Biodistribution Assay
RNA samples are tested with three reactions, along with a fourth reaction without the RT enzyme, to evaluate potential DNA contamination. For quantitation, a standard curve is prepared using an in vitro synthesized RNA reference sample.
Human Cell Biodistribution Assay
Our lab at Avance Biosciences has developed a sensitive Alu assay designed to detect low amounts of therapeutic human cells in animal tissues and bodily fluids. We pride ourselves on having the most robust Alu assay available, carefully balancing the need for sensitivity with stringent measures to minimize environmental contamination from human debris in the air, water, and reagents used.