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In the rapidly evolving fields of gene therapy, vaccine development, and cell therapy, viruses play critical roles as delivery vehicles, expression vectors, or direct therapeutic agents. Their quality, safety, and stability are pivotal to both product development and clinical success.
Leveraging years of expertise in virus platform technologies and a robust quality management system, Creative Biogene offers comprehensive virus bank characterization services tailored to the needs of the biopharmaceutical industry. Our advanced laboratory infrastructure, cutting-edge molecular biology technologies, and team of experienced virologists ensure accurate, regulatory-compliant characterization of master viral banks (MVBs) and working viral banks (WVBs).
The virus seed bank forms the foundation of virus-based biopharmaceutical manufacturing. Master and working viral banks serve as the primary raw materials in production and require rigorous evaluation to ensure:
Thorough characterization is essential not only for process quality assurance but also to meet global regulatory requirements from the FDA, EMA, NMPA, and ICH.
As the source of product quality, the completeness, safety, and stability of biological and molecular information in virus seed banks are crucial. Creative Biogene provides comprehensive virus bank characterization services to help clients meet CMC data requirements for regulatory agencies during IND/CTA submissions.
| Testing Dimension | Testing Content |
| Virus Identification | Whole genome sequencing, target gene sequence determination, Southern blot, restriction endonuclease analysis |
| Infectivity Testing | Virus titer (TCID50, Plaque), virus proliferation capacity testing |
| Stability Analysis | Generational genetic stability, mutation analysis |
| Microbial Contamination | Sterility, mycoplasma, mycobacterium, fungal/bacterial contamination testing |
| Endogenous/Exogenous Viruses | Screening for HIV, HBV, HCV, HTLV-1/2, HAV, BVDV, and multiple other viruses |
| Species-Specific Source Contamination | Detection of bovine, porcine, murine, insect, avian, and other species-specific viruses |
| RCL/RCR Detection | RT-qPCR/dPCR detection of retrovirus or replication-competent adenovirus |
| Safety Analysis | Cytotoxicity, tumorigenicity, tumor selectivity assessment, blood adsorption, and animal infectivity |
| Functional Validation | Target protein expression, BCA concentration analysis, and cell lysis capacity testing |
Creative Biogene offers end-to-end support for virus bank establishment and testing across vaccines, gene therapies, and cell therapy products. Our services cover the full range of virus bank types:
To ensure the integrity and suitability of each sample under different test conditions, we provide:
By integrating virus bank testing with method validation, we help ensure your products meet the highest safety and compliance standards from development through to clinical application.
We possess multiple high-sensitivity, GMP-compliant methodological platforms to meet testing needs for different virus types and samples.
RT-qPCR
Detection of rcAAV, RCL, replicating viruses, etc., with high sensitivity and strong specificity;
Digital PCR
Direct counting, suitable for low-copy virus detection, avoiding standard curve dependency;
Microbial and Virus Detection
DIncluding cell culture methods, chicken embryo methods, animal inoculation methods, electron microscopy, electrophoresis, ELISA, etc.;
Retrovirus Detection
PERT method combined with culture methods can detect RCR contamination and reverse transcriptase activity.
All services align with international standards and are supported by validated SOPs under ISO 17025 and GMP frameworks. Our data supports global submissions, including IND/CTA filings in China, the U.S., and Europe.
1Consultation: Project scope definition and virus information collection
2Planning: Customized assay panel and compliance strategy
3Sample Preparation: QC of MVB/WVB samples
4Testing & Validation: Execution of assays, interim updates
5Reporting: Final characterization report with regulatory-ready data package
Creative Biogene is your trusted partner for virus bank quality assurance. Let our expertise accelerate your biologics development. Contact us for project consultation or to request a service quotation.
Q1: How is the suitability of virus bank samples ensured for different assay platforms?
A1: We perform rigorous sample suitability validation, including spike-recovery tests and precision assessments, to ensure compatibility with qPCR, dPCR, culture-based, and molecular assays.
Q2: What types of virus banks are covered under your characterization services?
A2: We characterize Primary Virus Banks (PVB), Master Virus Banks (MVB), and Working Virus Banks (WVB), supporting each with identity, purity, and genetic stability assessments.
Q3: Can Creative Biogene help with regulatory submission for gene and cell therapy products?
A3: Yes. We provide full documentation aligned with FDA, EMA, NMPA, and ICH guidelines, including method validation reports, raw data, and GLP-compatible study summaries.
Q4: Do you support retrovirus-related safety assessments such as RCR or RCL detection?
A4: We offer sensitive qPCR/dPCR assays and PERT-based tests to detect replication-competent retroviruses (RCR) and lentiviruses (RCL), supporting gene therapy safety evaluation.
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