Our promise to you:
Guaranteed product quality, expert customer support.
24x7 CUSTOMER SERVICE
CONTACT US TO ORDER
Next-Generation Sequencing (NGS) has emerged as a critical, ultra-sensitive analytical tool for the molecular characterization, viral safety assessment, and quality control of modern biopharmaceutical products. By replacing or complementing traditional in vivo and in vitro assays, NGS provides unmatched resolution for establishing product purity and regulatory compliance.
Our biologics-focused NGS services seamlessly integrate high-sensitivity sequencing architectures with highly curated bioinformatics workflows. Engineered to meet the stringent demands of bioprocess development, we support impurity identification, viral vector stability profiling, genomic integrity verification, and IND/BLA-enabling regulatory research.
We partner with biopharmaceutical sponsors globally, providing robust sequencing solutions across complex biological matrices—ranging from viral vectors and advanced vaccines to cell therapies and recombinant proteins.
We support sequencing-based characterization and safety assessment for diverse biologics modalities throughout research, process development, and product evaluation workflows.
Monoclonal Antibodies
Support for residual nucleic acid assessment, contaminant investigation, and manufacturing-related characterization studies.
Viral Vectors
Comprehensive sequencing solutions for AAV, lentiviral, and other gene delivery systems.
Vaccines
NGS-based analysis for viral characterization, identity confirmation, and safety evaluation.
Exosomes
Profiling of exosome-associated RNA, DNA, and other nucleic acid cargo to support product characterization studies.
mRNA Therapeutics
Sequence verification and integrity analysis for mRNA-based therapeutic products.
Cell Therapy Products
Genomic characterization, vector-related analysis, and viral safety assessment for engineered cell therapy products.
Samples should meet project-specific concentration, purity, and storage requirements to ensure sequencing performance and da ta reliability.
In alignment with current industry trends and ICH Q5A (R2) guidelines, we offer two standardized pipelines integrating high-sensitivity sequencing with validated bioinformatics.
Focused on quality control and molecular profiling for cell and gene therapy (CGT) products:
An unbiased alternative to traditional assays for contamination screening in cell banks and raw materials:
| Output Category | Deliverables |
|---|---|
| Sequencing Data |
|
| Quality Reports |
|
| Bioinformatics Results |
|
| Final Study Report |
|
Our NGS techniques enable biologics research, process development and safety assessment with integrated sequencing and bioinformatics analysis.
What types of biologics samples can be analyzed?
We support viral vectors, vaccines, monoclonal antibodies, exosomes, cell therapy products, sera, and other biologics-related materials.
Can NGS detect completely unknown or novel viral contaminants?
Yes. Because our metagenomic workflows do not rely on organism-specific primers, they can capture and identify novel, divergent, or unexpected viral sequences by cross-referencing translated amino acid databases.
Do you support viral vector sequencing projects?
Yes. We provide sequencing and integrity analysis for AAV, lentiviral, and other viral vector systems.
Do you provide bioinformatics analysis?
Yes. Integrated bioinformatics analysis and customized reporting are included in our workflows.
Can your workflows support regulatory research?
Our workflows are designed to support research and safety assessment applications with standardized sequencing and data analysis strategies.
Can low-input or complex biologics samples be analyzed?
Yes. Sequencing strategies can be optimized for challenging sample types, including low-input materials, viral preparations, and complex biological matrices.
Discuss your project specifications, regulatory targets, and timeline matrices with our dedicated biopharma experts. We will co-develop an optimized, compliant sequencing layout tailored to your product.
Copyright © 2026 Creative Biogene. All rights reserved.