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.
Avance Biosciences™ is a world-leading CRO that provides CGMP and GLP-compliant biological testing solutions that support the biological drug development pipeline from discovery through manufacturing. We specialize in assay development, assay qualification or validation, and sample testing that complies with GLP and CGMP regulations.
AAV-based therapies, while an important gene therapy modality, can harbor sequence variations that may impact clinical efficacy. Tapestri® can enable direct AAV characterization through targeted amplicon sequencing, detecting genome variation at single-virion level.
For cell therapies that have an introduced transgene, Tapestri® can measure the transduction/transfection efficiency and vector copy number (VCN) at single-cell resolution. Unlike bulk PCR assays that report population averages, Tapestri® measures cell-to-cell variation in these attributes with no cell culture required.
On- and Off-Target
Gene Editing Analysis
For therapies modified by CRISPR or other gene-editing tools, Tapestri® can concomitantly measure on- and off-target editing in each cell. Additionally, multiplex editing, zygosity, and translocations can be assessed. In contrast to traditional bulk NGS analysis, Tapestri® measures the zygosity and co-occurrence of edits at the cellular level in your drug product.
Assessing the biodistribution of both ex vivo and in vivo cell and gene therapies is critical for ascertaining drug efficacy and safety prior and during clinical studies. Tapestri’s® multi-attribute, multi-omic single-cell platform can be used to accurately detect cell therapy distribution throughout the body, as well as detection of modified target cells from in vivo gene therapies in a variety of tissue types.
At Avance Biosciences™, we are committed to delivering top-quality results with rapid turnaround times and exceptional customer service. We understand the importance of your research and we are dedicated to helping you achieve your goals. Contact us to learn more about how Avance Biosciences™ and the Mission Bio Tapestri® Platform can help you advance your research in rare diseases. We look forward to connecting with you!
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
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.
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!
Dedication to Quality
The Avance Biosciences™ team is committed to strict adherence to GLP and CGMP 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.
Cutting Edge Science
Avance Biosciences™’ GLP/GMP compliant genomic and microbial assays make use of the advanced technologies including real-time PCR, digital PCR, Sanger sequencing, next generation sequencing, and more.