With our expertise and extensive experience in the “Gold-standard” qPCR assay development and validation, Avance Biosciences offers comprehensive qPCR biodistribution studies designed to determine the distribution of gene therapy vectors in intended and distant tissues. Our custom-designed GLP compliant qPCR biodistribution study assays offer a powerful tool to address the safety and efficacy concerns and satisfy the requirements for regulatory agencies worldwide.
Sensitive and target-specific qPCR assays can be custom designed and validated to assess the presence/absence of gene therapy vectors in tissues collected in a preclinical animal study. The assay will meet or exceed FDA’s requirement on sensitivity (50 copies/microgram of host DNA), and will be validated per ICH guidelines. DNA extraction method will also be validated to evaluate recovery and PCR inhibition effect.
Avance Biosciences is experienced with performing DNA and RNA extractions from any types of animal tissues, blood, CSF, and urine, with good quality and free from cross-contamination. Our study directors and lab analysts have the reputation of working hard to ensure successful and timely completion of preclinical and clinical studies with large number of samples, under GLP.
If a gene insertion study is required by regulatory agencies, Avance Biosciences can help our clients to design and execute custom assays for this purpose. We use a combination of NGS, PCR, and Sanger sequencing methods to delineate and validate potential insertion junctions and their locations in host genome.
We are dedicated to timely, high-quality service from the start of your project to the finish. Send us a note or give us a call to find out what Avance can do for you.
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!
Dedication to Quality
The Avance Biosciences team is committed to strict adherence to CGMP and GLP regulations enacted by the US, European, Japanese, and other international regulatory agencies.
Our team has extensive knowledge and experience working with scientists, QA/QC professionals, and project managers from over 100 pharmaceutical and biotechnology companies and organizations throughout the world.
Transparency and integrity are two of our core values. Our well-trained, friendly, and professional study directors and project managers strive to complete your projects on-time with open communication channels and to your specifications.
Avance Biosciences’ GLP/GMP compliant genomic and microbial assays make use of the advanced technologies including real-time PCR, ddPCR, Sanger sequencing, next-gen sequencing, Southern blot, and more.