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Cell & Gene Therapy Biosafety Testing

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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.

Figure 1 illustrates the key safety testing in the CGT (Cell and Gene Therapy) manufacturing process, highlighting the critical steps and methods used to ensure product safety.

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
  • Compliance Facilities

  • 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.
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