Sequence Confirmation by NGS

NGS delivers accurate, high-resolution sequence confirmation, overcoming the limitations of Sanger sequencing in GC-rich regions, short RNAs, and complex CRISPR constructs.

Detect minor impurities and confidently analyze single or mixed plasmid, mRNA, and sgRNA sequences with comprehensive NGS coverage.

As the first company in the world to introduce Illumina NGS platform in GMP QC environments back in 2012, Avance Biosciences is a pioneer in applying NGS technology to support drug development and manufacturing. We offer advanced and comprehensive NGS ID testing services for plasmids, viral vectors, sgRNA, and mRNA used in gene therapy, vaccine development, and other biopharmaceutical applications.

Reliable 21 CFR Part 11 Compliant NGS Analysis

Running NGS is easy, but meeting FDA 21 CFR Part 11 compliance is not. Avance Biosciences delivers validated NGS data analysis pipelines with built-in audit trails to ensure data integrity and traceability. Our regulatory-ready approach supports high-quality, compliant results for biopharmaceutical development and manufacturing.

Improved NGS Sequence Confirmation with Avance as Your Testing Partner

Fast Turnaround: From sample to data in under 2 weeks to keep your timelines on track.
High Coverage: Reliable sequencing across challenging secondary structures and high GC content regions.
Quality Assurance: Q30 or higher sequence quality for confident interpretation.
PCR-Free Prep: Reduced bias and preserved native sequences.
Regulatory Compliance: Validated analysis pipelines designed to meet 21 CFR Part 11 requirements.
Structural Assessment: Evaluate DNA or RNA integrity, including detection of degradation or breaks.
Contamination Detection: Sensitive identification of cross-contamination or foreign sequences.
Assay Validation: Full assay validation available to support CGMP-compliant sample release testing.

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