Biopharmaceutical drug discovery and development requires a solid understanding of the therapeutic target, conformation and characterization of drug candidates, and customized solutions for pre-clinical and clinical testing.
We offer a broad range of assay development services, including assay design, assay validation, sample testing, and technology transfer under GLP compliance to support IND-enabling and clinical studies. With decades of experience helping gene and cell therapy companies, Avance Biosciences has the expertise and track record to assist you with your biological drug discovery and development.
We’re here to advance your biological discovery and development. We do it with solid science, strict regulatory compliance, and an experienced team to streamline the process.
Biopharmaceutical drug discovery and development requires a solid understanding of the therapeutic target, conformation and characterization of drug candidates, and customized solutions for pre-clinical and clinical testing.
We offer a broad range of assay development services, including assay design, assay validation, sample testing, and technology transfer under GLP compliance to support IND-enabling and clinical studies. With decades of experience helping gene and cell therapy companies, Avance Biosciences has the expertise and track record to assist you with your biological drug discovery and development.
We’re here to advance your biological discovery and development. We do it with solid science, strict regulatory compliance, and an experienced team to streamline the process.
Project Management
- Collaboration with you to develop and qualify assays, and perform sample testing
- Dedicated project manager, senior scientist, and study director to lead your project
- Regularly scheduled project check-in meetings to review data and discuss next steps
- Flexible structure to accommodate changing requirements
- Sound scientific approach and methods
Assay Development
- Robust assay design
- Specificity, sensitivity, accuracy, and precision determination
- Development of appropriate control and reference samples
- Advanced development and pre-qualification of all parameters associated with qualification and validation to fully characterize assay performance
Qualification & Validation
- Follow FDA/ICH guidelines for assay qualification and validation
- Parameters include specificity, sensitivity, precision/accuracy, robustness, extraction efficiency, and more
- Mutually agreed on pass/fail criteria determined in advanced development
- QA reviews all data, test plans, and final report
- Ability to validate NGS data analysis pipeline
Applications
We offer tailored GLP-compliant assay solutions in several application areas, driving your discovery and development efforts forward with reliable, trusted results.
- DNA and RNA biodistribution studies
- Gene expression studies
- Protein studies with ELISA and western blot
- CRISPR on-/off-target evaluation
- Gene editing translocation evaluation
- Single-cell amplicon NGS assays
- NGS integration analysis for gene editing and gene therapy
- Vector copy number (VCN) analysis for inserted genes
- Colony forming unit assays (CFU)
- Viral titer determination
- Custom assay design and validation
Avance Biosciences is a leading CRO providing CGMP and GLP-compliant assay development, assay validation, and sample testing services to support biological drug development and manufacturing activities world-wide. We specialize in assay development, assay qualification or validation, and sample testing that complies with GLP and CGMP regulations.
Our CGMP/GLP-compliant qPCR services are established to support the identity and safety test of CGMP biologics, the analysis of preclinical and clinical trial samples, and the validation of DNA-based tests and devices for PMA or 510K clearances. Custom qPCR assay design and validation of target specific assays are routinely designed, qualified or validated at Avance Biosciences.
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!
