Biosafety solutions

RSSL's biosafety solutions - protecting clients products and ensuring consumer safety

 

When it comes to product integrity and consumer safety RSSL’s cutting-edge biosafety solutions deliver the protection and confidence you need. Our state-of-the-art laboratories, featuring segregated bioassay suites and one-directional PCR suites, provide world leading analytical services designed to safeguard your products and your reputation.

 

We go beyond testing, offering client-specific method development and validation in accordance with ICH Q2(R2) standards, ensuring compliance and accuracy. From microbial testing to impurity analysis, we deliver fast, reliable results tailored to your timeline.

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    Adventitious agents and viral clearance

    •    Genetic detection 
    •    Sequencing 
    •    qPCR/ddPCR based assays 
    •    Infectious virus testing 
    •    In vitro based testing using various continuous cell lines or immortalised primary cell 
    •    Sub-culture 
    •    Co-Cultivation Assays
    •    End point titration with CPE or immunofluorescence end point 
    •    Neutralisation assays 
    •    Visualisation

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    Viral vectors

    •    Capsid Characterisation
    •    VP stoichiometry
    •    Full:Empty capsid
    •    Genomic content/size
    •    Aggregation
    •    DNA identity
    •    Genetic cargo
    •    Total capsid titre 
    •    Infectivity titre 
    •    Genomic titre
    •    Transgene detection (Protein expression, copy number by qPCR)

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    Microbial testing

    •    Mycoplasma, including culture, indicator, and NAT methods 
    •    Sterility, including rapid sterility 
    •    Cleaning and disinfectant validation 
    •    Environmental monitoring 
    •    Endotoxin testing 
    •    Adventitious agents 
    •    Microbial identification 
    •    Microbial limit tests

 

Impurities and contamination

 

We ensure your products safety and compliance with our comprehensive process-related impurity analytical solutions. From growth factors, antibiotics and solubilisers to product-related impurities such as HCP, HCDNA and aggregates, we deliver precise, reliable results. We also offer advanced investigational testing, including subvisible and visible particle analysis, which provides the confidence you need to meet the highest quality standards.

RSSL is a trusted partner for global pharmaceutical and biotech leaders, providing industry-leading expertise in biosafety testing. Our fast, reliable results help you meet critical milestones without delays, ensuring your products remain on track for success. We guarantee regulatory compliance, adhering to ICH Q2(R2), GMP, and global standards, so you can move forward with confidence.

Resources

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Biosafety Image
Life Science & Pharmaceuticals
Biosafety solutions
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Transgene Image
Life Science & Pharmaceuticals
Overcoming transgene detection challenges in viral vector therapeutics
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Biological Roadmap
Life Science & Pharmaceuticals
Biological road map
Find out how our biosafety solutions can protect your products and accelerate success

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