Avance Biosciences
Avance Biosciences is a leading Contract Research Organization (CRO) and Contract Testing Organization (CTO) providing CGMP and GLP-compliant analytical and bioanalytical services to support drug development, manufacturing, and genomic research. With extensive experience and a commitment to quality, they offer innovative solutions in method development, validation, and sample testing across various therapeutic modalities, including gene and cell therapies, biologics, and vaccines. Their services support regulatory submissions and help accelerate the development of groundbreaking medicines.
Industries
Nr. of Employees
medium (51-250)
Avance Biosciences
Products
NGS Center of Excellence (sequencing facility)
A dedicated facility offering regulated NGS testing and bioinformatics for biologics, gene and cell therapy development, including GLP/CGMP/CLIA-capable workflows.
NGS Center of Excellence (sequencing facility)
A dedicated facility offering regulated NGS testing and bioinformatics for biologics, gene and cell therapy development, including GLP/CGMP/CLIA-capable workflows.
Services
End-to-end development and validation of molecular and protein assays to support preclinical, clinical, and manufacturing release activities in regulated environments.
GMP-compliant quality control testing for plasmids, viral vectors, mRNA, cell therapies, and biologics including identity, purity, potency, and stability assays.
Short- and long-read sequencing, single-cell sequencing, integration-site analysis, on/off-target gene editing analysis, and NGS-based adventitious agent detection.
Validated assays and sample testing for PK/PD, biodistribution, immunogenicity (ADA/NAb), biomarker testing, and long-term follow-up in GLP/clinical contexts.
Cell bank testing, microbial assays, phage/viral contaminant identification, sterility, mycoplasma, and method development for microbial detection.
Validation of diagnostic tests using regulatory 'gold standard' methods and provision of CLIA-registered laboratory testing capabilities.
End-to-end development and validation of molecular and protein assays to support preclinical, clinical, and manufacturing release activities in regulated environments.
GMP-compliant quality control testing for plasmids, viral vectors, mRNA, cell therapies, and biologics including identity, purity, potency, and stability assays.
Short- and long-read sequencing, single-cell sequencing, integration-site analysis, on/off-target gene editing analysis, and NGS-based adventitious agent detection.
Validated assays and sample testing for PK/PD, biodistribution, immunogenicity (ADA/NAb), biomarker testing, and long-term follow-up in GLP/clinical contexts.
Cell bank testing, microbial assays, phage/viral contaminant identification, sterility, mycoplasma, and method development for microbial detection.
Validation of diagnostic tests using regulatory 'gold standard' methods and provision of CLIA-registered laboratory testing capabilities.
Expertise Areas
- Bioanalytical method development and validation
- Next-generation sequencing and genomic analysis
- CMC analytical support for biologics and cell/gene therapies
- Preclinical PK/PD and biodistribution studies
Key Technologies
- Next-generation sequencing (short-read)
- Long-read sequencing (third-generation)
- Single-cell sequencing
- Sanger sequencing
News & Updates
Using next-generation sequencing to identify phage contaminants in an E. coli cell bank, enabling source tracing, risk assessment, and corrective actions within four weeks.
Delivering a validated NGS assay to measure gene editing efficiency in rat tissues, supporting IND studies.
Providing a low-level variant detection and contaminant analysis assay for plasmid verification supporting FDA compliance.
Using next-generation sequencing to identify phage contaminants in an E. coli cell bank, enabling source tracing, risk assessment, and corrective actions within four weeks.
Delivering a validated NGS assay to measure gene editing efficiency in rat tissues, supporting IND studies.
Providing a low-level variant detection and contaminant analysis assay for plasmid verification supporting FDA compliance.