Biologics products are highly regulated by global health safety authorities, such as the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA). Strict specific tests and controls to ensure production safety and contamination are
required for any biological products. Creative Biolabs, having nearly 20 years of experience as a leading supplier of biologics safety testing and contamination testing,
provides comprehensive off-the-shelf analysis to generate detailed reports to ensure cell and viral banks, bulk harvests and clinical batches are sterile of bacteria, fungi, yeast, mycoplasma, foreign viruses and any other potential contaminants.
All of these tests are conducted in our cGMP biosafety laboratory.
If You Want to Detect
Nucleic Acids (DNA/RNA)
Proteins and Antigens
Microbial Contaminants and Cellular Safety
Technique/Assay
Detection Application
Key Features
PCR, qPCR, ddPCR
Detects viral, bacterial, and fungal DNA/RNA
- High sensitivity and specificity
- qPCR: real-time quantification
- ddPCR: absolute quantification of low-abundance targets
CRISPR-based Detection
Rapid detection of specific RNA sequences
- High precision
- Minimal equipment
- Fast results
Next-Generation Sequencing (NGS)
Comprehensive genomic profiling, ideal for novel or unknown viruses
- Whole-genome analysis
- Detects unknown contaminants
- High information yield
Technique/Assay
Detection Application
Key Features
ELISA
Detects and quantifies specific proteins or antigens
- High throughput
- Quantitative
- Cost-effective
Western Blot
Confirms presence and molecular weight of proteins
- Multi-parameter analysis
- Detects minor cell populations
- Essential for quality control
Technique/Assay
Detection Application
Key Features
Adventitious Agent Detection
Detects hidden viral or bacterial agents in biological products
- High sensitivity
- Uses natural hosts
- Regulatory compliance
Tumorigenicity Assay
Evaluate the tumor-forming potential of cells
- Long-term safety
- Critical for gene and cell therapy
- Regulatory requirement for vaccines
Infectivity Testing
Confirms virus replication and infectivity in controlled systems
- Ensures viral clearance
- High precision
- Essential for vaccine production
Mycobacteria Detection
Detects contamination by mycobacteria in cell cultures
- High sensitivity
- Prevents contamination
- Meets regulatory standards
This classification organizes biosafety testing methods according to the molecule type detected (nucleic acids, proteins, microbial contaminants) and highlights the key features of each technique. This structure aids in quickly identifying the appropriate
test for specific biosafety needs.
Highlights from Creative Biolabs
With our level of expertise in virology, cell and molecular biology, and state-of-the-art microbiology and electron microscopy instrumentation, we perform full biologic safety analyses to enable you to verify product safety and regulatory compliance.
Fast turnaround times
Very fast turnaround time is one of our main strengths.
Reliable Quality Standard
Our laboratories comply with the regulatory requirements to meet the rigorous standard required for the supply of analytical services for QC and product release.
Cutting-edge equipment
Automated balancing systems, such as pipetting or DNA extraction robots, work hand-in-hand with professionals to achieve maximum flexibility and optimal reproducibility.
In addition to cell bank and virus seed identification based on major pharmacopeia and regulatory guidelines, we also provide final product testing for residual DNA and other process-related impurities. In addition, we offer custom development of formulation studies and stability studies, regulatory and safety consulting and analysis.
To find out more about our biosafety testing services for biologics, please contact us.
Nucleic Acids (DNA/RNA)
Proteins and Antigens
Microbial Contaminants and Cellular Safety
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