Kits
Complete | Convenient | High Sensitivity
Chromogenic LAL Endotoxin Assay Kit ensures precise, FDA-compliant endotoxin quantification for biosafety testing.
Custom Viral Service
Versatile | High-Yield | Safe
Unbeatable pricing, fully customizable viral packaging services (covering 30,000+ human genes, 200+ mammals, 50+ protein tags).
Nucleotides Service
Accurate | Flexible | High-Quality
Custom synthesis of oligonucleotides, primers, and probes for gene editing, PCR, and RNA studies.
Target-based Drug Discovery Service
Innovative | Comprehensive | Efficient
Target identification, validation, and screening for drug discovery and therapeutic development.
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.
We offer a wide range of services that cover every stage of product development, from raw materials to final product release, including:
Ensure your product meets the highest biosafety standards with our cutting-edge testing tools:
Characterize your cell lines and virus banks to ensure their identity, purity, and stability:
Creative Biogene provides high-quality material testing services across all manufacturing stages, adhering to global pharmacopeia standards to ensure product quality and optimize efficiency.
Ensure your product is free from harmful microorganisms:
Protect against viral contamination in products made from cell lines with:
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:
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.
Rigorous quality controls ensure accurate and reproducible results with comprehensive documentation to support regulatory submissions.
We offer expert advice on test selection and ensure optimal sample preparation based on product needs and regulations.
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.
In-Process Quality Control Standards
Comprehensive Personnel Training
Validated Manufacturing Processes
Qualified Cleanroom & Equipment Validation
Raw Material Authentication & Traceability
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.
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.
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.
Tel
1-631-626-9181 (USA)
44-207-664-8911 (Europe)
Fax
1-631-614-7828
USA
SUITE 115, 17 Ramsey Road, Shirley, NY 11967, USA
Germany
Industriepark Höchst, Gebäude G830 65929 Frankfurt am Main
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