Assay Development and Validation
Ensure accurate and reliable results with expertly designed and validated bioanalytical assays.
Our proven methods support critical preclinical and clinical decisions, streamline regulatory submissions, and accelerate your path to market while maintaining the highest standards of safety and efficacy.
We support your IND-enabling studies and clinical trials
At Avance Biosciences, we specialize in bioanalytical method development services, covering assay design, validation, sample testing, and technology transfer under GLP standards. With extensive experience supporting clients engaged in the development of biologics, vaccines, and gene and cell therapies, Avance Biosciences provides the expertise and proven capabilities essential for advancing your biological drug discovery and development efforts.
Assay Development
- Creative designed assay to address your most challenging testing needs
- Experienced in assay performance improvement for specificity, sensitivity, accuracy, and precision
- High quality control and reference samples
- Advanced development and pre-qualification of all parameters associated
Qualification & Validation
- Adherence to FDA guidance and ICH guidelines for assay validation
- Comprehensive validation parameters including specificity, sensitivity, precision/accuracy, robustness, extraction efficiency, and more
- Quality assurance oversight of all data, test plans, and final reports
Project Management
- Dedicated study director, senior scientist, or project manager to oversee your project
- Collaborative approach to developing and validating assays with effective problem-solving
- Regularly scheduled project check-in meetings to review data and discuss next steps
- Flexible structure to accommodate changing requirements
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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