Ensure the Success of Your Biological Drug Development
What We Do
Biopharmaceutical drug development requires extensive biological testing for raw material release, in-process quality control, and final product characterization to secure product safety and satisfy the regulatory requirements of the FDA and other regulatory agencies.
We offer CGMP/GLP-compliant assay development, assay validation, and sample testing services to ensure strict regulatory compliance and a smooth journey to market. Using ICH guidelines, we offer a broad range of biologics quality control assays, including:
- Cell bank characterization
- Plasmid and viral vector ID testing
- Residual DNA and host cell protein testing
- Compendial assays
- Gene therapy drug substance and product release assays
- Custom assay development, validation, and more
Ensure the Success of Your Biological Drug Development
What We Do
Biopharmaceutical drug development requires extensive biological testing for raw material release, in-process quality control, and final product characterization to secure product safety and satisfy the regulatory requirements of the FDA and other regulatory agencies.
We offer CGMP/GLP-compliant assay development, assay validation, and sample testing services to ensure strict regulatory compliance and a smooth journey to market. Using ICH guidelines, we offer a broad range of biologics quality control assays, including:
- Cell bank characterization
- Plasmid and viral vector ID testing
- Residual DNA and host cell protein testing
- Compendial assays
- Gene therapy drug substance and product release assays
- Custom assay development, validation, and more
Our Comprehensive CGMP-Compliant Biologics Testing Solutions
We offer tailored services that provide you with a powerful way to address identity, stability, and safety concerns, satisfying the requirements of regulatory agencies worldwide.
Our Comprehensive CGMP-Compliant Biologics Testing Solutions
We offer tailored services that provide you with a powerful way to address identity, stability, and safety concerns, satisfying the requirements of regulatory agencies worldwide.
CAR-T and other gene or
cell therapy product release
Replication competent lentivirus (RCL) and vector copy number (VCN) testing
qPCR and ddPCR assays for integrated gene copy analysis
NGS amplicon sequencing for product characterization
Potency and infectivity assays
Transfection assay via single-cell NGS
Transfection assay via colony picking and Sanger sequencing
STEMvision™ for colony-forming unit (CFU) assays
DNA sequencing and residual host cell
DNA assays for product release
Sanger sequencing for plasmid drug products and viral vaccines
NGS for inverted terminal repeats (ITR), GC-rich, and other challenging constructs
cDNA sequencing and qPCR for multi-valent RNA vaccines
qPCR residual host cell DNA testing for protein drug products
Cell bank and viral seed
characterization assays
Microbial assays for bacterial cell bank release, including identity, purity, stability, viability, and phage contamination
qPCR and ddPCR for plasmid copy number or inserted gene copy number
Sanger sequencing for plasmid and inserted gene sequence verification
Next-generation sequencing (NGS) for plasmid and viral genome confirmation
Restriction mapping for plasmid evaluation
Southern blots for integration site and inserted gene structure analysis
NGS for phage ID
CAR-T and other gene or cell therapy product release
Replication competent lentivirus (RCL) and vector copy number (VCN) testing
qPCR and ddPCR assays for integrated gene copy analysis
NGS amplicon sequencing for product characterization
Potency and infectivity assays
Transfection assay via single-cell NGS
Transfection assay via colony picking and Sanger sequencing
STEMvision™ for colony-forming unit (CFU) assays
DNA sequencing and residual host cell DNA assays for product release
Sanger sequencing for plasmid drug products and viral vaccines
NGS for inverted terminal repeats (ITR), GC-rich, and other challenging constructs
cDNA sequencing and qPCR for multi-valent RNA vaccines
qPCR residual host cell DNA testing for protein drug products
Cell bank and viral seed characterization assays
Microbial assays for bacterial cell bank release, including identity, purity, stability, viability, and phage contamination
qPCR and ddPCR for plasmid copy number or inserted gene copy number
Sanger sequencing for plasmid and inserted gene sequence verification
Next-generation sequencing (NGS) for plasmid and viral genome confirmation
Restriction mapping for plasmid evaluation
Southern blots for integration site and inserted gene structure analysis
NGS for phage ID
Who We Are
A world leading CRO providing CGMP/GLP compliant biological testing solutions supporting the biological drug development pipeline from discovery through manufacturing. Our team has decades of experience in supporting cell-based drug manufacturing. With our technical expertise, focus on a strong adherence to regulatory guidelines, and dedication to exceeding our client’s expectations, we provide creative solutions to assure your drug development success.
Meet With Our Experts Today
We are a team of dedicated scientists, and quality control professionals focused on meeting your needs and completing your challenging drug development and manufacturing projects. By partnering with us, you’ll benefit from collaboration with a scientific team with decades of experience designing, validating, and executing biological assays and tests for regulatory submission.
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
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!
