Assay Development and Validation
Bioanalytical assay design and validation are crucial in biopharmaceutical development, ensuring accurate, reliable, and compliant assessment of drug safety, efficacy, and quality. Careful assay design is essential for accurately measuring biomarkers or drug concentrations in complex biological samples. Validation confirms the precision, accuracy, sensitivity, and robustness of these methods across various conditions, ensuring reproducible results. Reliable bioanalytical methods support critical decisions in preclinical and clinical studies and streamline regulatory submissions, expediting biopharmaceutical development while upholding standards of patient safety and product efficacy.
Our Expertise
At Avance Biosciences, we specialize in bioanalytical method development services, covering assay design, validation, sample testing, and technology transfer under GLP standards. Our offerings are designed specifically to facilitate IND-enabling studies and clinical trials. 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. Our commitment to rigorous science and regulatory compliance, coupled with a seasoned team, ensures a streamlined path towards your goals in biological research and development.
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
Case Studies
- 2013 Established MiSeq sequencing workflow under GMP to support a client for companion diagnostic assay validation. In a pilot study, we outperformed two major sequencing service provider and established a two-step amplicon sequencing assay to confirm the mutations in the qPCR primers of companion diagnostic assay.
- 2019 Collaborating with a bay area big pharm company, we established a GUIDE-Seq workflow, from wet lab to bioinformatics pipeline, for CRISPR gene editing target on/off analysis.
- 2019 Collaborating with a bay area big pharm company, we established a rhAmpSeq workflow, from wet lab to bioinformatics pipeline, for CRISPR gene editing target on/off analysis.
- 2021 To assist a client to develop a Covid19 plasmid vaccine, we developed and validated a unique target sequencing assay to determine whether an the plasmid is integrated into host genome during an animal biodistribution study. This assay is able to detect 10 copies of potential integration event in 1 microgram host genomic DNA.
- 2021 Tech-transferred and qualified a Single-cell DNA sequencing assay from MissionBio and a Biotech client to determine the percent of transduction in edited CD34+ cells using Tapestri platform and Nextseq.
- Developed and validated an NGS-based amplicon sequencing to evaluate gene editing profile in a development of CRSIPR/Cas-9 cell therapy that is approved by FDA in 2024. Thousands of samples were analyzed under GLP using QPCR, ddPCR, and NGS to support both preclinical and clinical samples.
- Developed and validated a multi-valent RNA vaccine release assay using QPCR that determines the ratio of all RNA in the drug substance. We creatively solved the issue of unequal reverse transcription efficiency among different RNAs, and the assay has been used by a mRNA covid-vaccine manufacturer for drug substance and product release.