Biosafety Testing Services

The biopharmaceutical industry has witnessed remarkable growth and transformation, with over 3,700 cell and gene therapy products currently in development and more than 100 approved therapies globally. At Creative Biogene, we offer comprehensive biosafety testing services that fully comply with pharmacopeia requirements and regulatory guidelines. Our team conducts standardized tests on your products, raw materials, intermediates, and manufacturing processes using established pharmacopeial methods. With extensive experience in biological product testing, we know that performing these tests in-house can be resource-intensive and complex. Whether you're developing cell and gene therapies or other biological products, we are your trusted partner, helping streamline your development process while ensuring regulatory compliance.

Our Core Biosafety Testing Services

We offer a wide range of services that cover every stage of product development, from raw materials to final product release, including:

Analytical Testing Services

Ensure your product meets the highest biosafety standards with our cutting-edge testing tools:

Characterization Services

Characterize your cell lines and virus banks to ensure their identity, purity, and stability:

Material Testing Services

Creative Biogene provides high-quality material testing services across all manufacturing stages, adhering to global pharmacopeia standards to ensure product quality and optimize efficiency.

Microbiology Testing Services

Ensure your product is free from harmful microorganisms:

Virology Testing Services

Protect against viral contamination in products made from cell lines with:

Why You Need Us: Overcoming Common Biosafety Testing Challenges

Creative Biogene provides comprehensive biosafety testing services following pharmacopoeia requirements and regulatory guidelines. Our experienced team helps ensure your products meet quality and safety standards through:

Standardized Testing Expertise

We adhere to ICH, FDA, EP (5.2.3), and WHO guidelines for reliable biosafety testing across all product stages. Our team is experienced in applying these diverse pharmacopoeia standards to ensure compliant testing that meets your regulatory requirements.

Quality Assurance

Rigorous quality controls ensure accurate and reproducible results with comprehensive documentation to support regulatory submissions.

Technical Support

We offer expert advice on test selection and ensure optimal sample preparation based on product needs and regulations.

Efficient Project Management

Our robust management system streamlines workflows, reduces turnaround times, and integrates each project phase. Enhanced communication and coordination accelerate progress, with proactive planning and monitoring to ensure timely, high-quality completion.

Deviation Management & CAPA

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In-Process Quality Control Standards

Comprehensive Personnel Training

Validated Manufacturing Processes

Qualified Cleanroom & Equipment Validation

Raw Material Authentication & Traceability

Partner with Creative Biogene for Reliable Biosafety Testing

At Creative Biogene, we take pride in offering comprehensive, reliable, and compliant biosafety testing services that ensure the safety of your biological products. With our expertise, cutting-edge technology, and deep understanding of global regulatory requirements, you can rest assured that your products meet the highest safety standards.

Our Commitment to You:

Tailored Testing Strategies:

We work with you to create a customized biosafety testing plan that suits your specific needs and product types.

Reliable Results:

Our advanced testing platforms and experienced team ensure accurate, reproducible, and fast results, helping you stay on track.

Global Compliance:

We ensure that your products meet the required standards for regulatory approval, whether you're developing therapies for local markets or global distribution.

Get Started Today

Don’t let biosafety testing slow down your development process. Let Creative Biogene handle the complexities, so you can focus on what matters: advancing your product to market. Reach out to us today for more information or to discuss your specific biosafety testing needs. We’re here to support you every step of the way.

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