Cell & Gene Therapy Biosafety Testing
OverviewServicesQualificationContact Us
To date, over 100 gene, cell, and RNA therapies have received global approval, with more than 3,700 products in development. Genes account for 55% of these innovations, while cell therapies represent 53%. In this flourishing field, stability, safety, and proven efficacy are paramount in driving the continuous advancement of Cell and Gene Therapy (CGT) products.
Comprehensive Biosafety Testing Solutions for CGT Products
Creative Biogene is a global biotechnology company specializing in providing biosafety testing services designed to ensure the safety and compliance of your CGT products. Our services encompass comprehensive testing solutions across the entire product lifecycle, including identity testing, potency assays, and purity assessments.

With our dedicated laboratory operations and development service teams, we consistently deliver high-quality results with exceptional turnaround times to meet the evolving demands in this dynamic field. These services strictly comply with the regulatory requirements of government (FDA, EMA, ICH and WHO).
Extensive Service Portfolio

Cell line identification
Sterility testing
Mycoplasma testing
In vitro assay for adventitious agents
In vivo assay for adventitious agents
Antibody production assay
Porcine viruses testing
Bovine viruses testing
Species-specific viruses testing
Sequencing of inserted gene
Restriction enzyme analysis
Gene copy number analysis
Localization of DNA sequences
Bioburden
Mycoplasma testing (PCR)
Retrovirus testing
Transmission electron microscope
In vitro assay for adventitious agents
Identity
Purity
Adventitious Virus
Genetic Stability
Unpurified Bulk
Virus Clearance Service
E.coli/Plasmid
Host Cell
Down Stream Process
Formulation & Filling
Identity
Viability
Purity
Biochemical Marker
Genetic Stability
Drug Substance
Drug Product
Identification with randomly amplified polymorphic DNA
Bacterial viability in microbial bank
Purity testing of microbial bank
Gram's staining
Bacteriophage detection
Genotype/phenotype testing
Retention of plasmid in microbial bank
Plasmid identity by restriction enzyme analysis
Plasmid copy number detection in microbial bank
Sequencing analysis of recombinant plasmid
Sterility testing
Endotoxin detection
Residual host cell DNA testing
Residual host cell protein testing
Residual protein A testing
Product specific identity assay
Biological activity
Total protein
Osmolality
pH
Conductivity
Particulates
Appearance
Comprehensive Quality Management System
Creative Biogene implements comprehensive measures in information protection, quality management, regulatory compliance, and authorized qualifications to guarantee that all tests are compliant. We utilize advanced information protection systems to safeguard sensitive data and intellectual property while running a comprehensive quality management system to supervise the quality of our safety testing service. We strictly adhere to international regulations, including FDA and EMA guidelines, to ensure compliance and minimize legal risks.
"3C" Excellence Guarantee
- Comprehensive Certifications
Our commitment to excellence is validated through prestigious certifications:- EU GMP Qualified Person (QP) Authorization
- FDA FEI Number Registration
- ISO 9001:2015 Certification
- BSL-2 Certification

- Complete Quality Management System

Partnering With Us
Professional project team
One-stop integrated services
Fully-documented testing reports
As cell and gene therapy constantly evolves, Creative Biogene is poised to support your journey from development to market authorization. Our comprehensive testing services, regulatory expertise, and commitment to innovation make us the ideal partner for navigating the complexities of CGT development.
Contact us today to discover how our CGT safety testing services can accelerate your path to clinical success and market approval!
* For research use only. Not intended for any clinical use.