Non-clinical and clinical studies that evaluate pharmacokinetic (ADME) and toxicology characteristics are necessary to determine the safety and efficacy of cell and gene therapy products. These studies encompass various critical aspects, including AAV biodistribution, 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.
The team at Avance Biosciences™ has nearly three decades of experience providing services to support cell and gene therapy biodistribution and pharmacokinetics studies, including qPCR, ddPCR, and NGS. Throughout the years, we have designed and validated numerous TaqMan assays and analyzed significant quantities of animal tissue samples.
We specialize in assay development, assay qualification or validation, and sample testing that complies with GLP and CGMP regulations.
Biodistribution of DNA
Viral Vectors or Transgenes
The biodistribution of viral vectors or transgenes is an important part of pre-clinical pharmacokinetics and toxicology studies. To support biodistribution and pharmacokinetics studies, Avance offers GLP and Non-GLP qPCR, ddPCR, and NGS testing services. Our team has extensive experience in qPCR biodistribution assay development, validation, and sample testing.
Biodistribution of
RNA Transgenes
The biodistribution of RNA transgenes is typically a requirement for RNA-based CGT products. To determine RNA transgene biodistribution, we provide RT-qPCR method with RNA standard curves to test genes that are not naturally present in testing animals addressing this critical aspect of toxicology studies.
Biodistribution of
Therapeutic Cells
Determining the biodistribution of therapeutic cells is essential for understanding the efficacy and safety of a cell and gene therapy product. The team at Avance Biosciences™ has extensive expertise in developing sensitive and specific qPCR, ddPCR, and NGS methods to quantify human cells in animal tissues, a vital component of biodistribution and pharmacokinetics assessments.
Tissue DNA/RNA
Extraction
Avance Biosciences™ takes the utmost precautions to prevent sample cross-contamination in various lab processes, including tissue cutting, homogenization, and extraction, DNA/RNA quantitation and normalization, and PCR plate setup. Our extraction methods are tailored to the animal species and vector type, ensuring high-yield and high-quality vector DNA recovery, a key factor in toxicology studies.
Whether you are working on plasmid-based or AAV gene therapies, CAR-T cell therapeutics, or iPSC-based therapies, Avance Biosciences™’ experienced team of scientists has seen it all. We can assist you in developing specific and sensitive assays for your AAV biodistribution studies as well as your gene and cell therapy biodistribution studies.
Controlled laboratory environments during sample processing to prevent cross-contamination
Methods validated per ICH guidelines
Independent quality unit assuring regulatory compliance
Rigorous sample management and tracking to ensure chain of custody
Reports readily accepted by regulatory authorities
Open communication between our study directors and clients
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