Analytical Testing & Quality Control
Creative Biolabs delivers comprehensive analytical testing and quality control services that ensure the safety, efficacy, and consistency of gene therapy products throughout the development lifecycle. Our integrated QC platform combines advanced analytical methodologies with rigorous testing protocols, providing complete characterization of both viral vectors and nucleic acid therapeutics. From identity confirmation to potency assessment, our services meet the highest industry standards and regulatory requirements, supporting your journey from research through clinical development with confidence and precision.
Our Services
Guarantee the quality and therapeutic potential of your oligonucleotide products through our comprehensive nucleic acid analysis services. Our analytical platform addresses all critical quality attributes for diverse nucleic acid modalities including ASOs, siRNAs, aptamers, and circRNAs. Identity confirmation utilizes advanced techniques such as mass spectrometry, LC-MS/MS, and next-generation sequencing to verify sequence accuracy and modifications. Concentration determination employs UV absorbance, fluorometric methods, and qPCR for precise quantification. Safety evaluation includes comprehensive testing for endotoxins, microorganisms, human source contamination, and assessment of toxicity and immunogenicity profiles. Potency analysis combines in vitro functional assays, in vivo biological activity studies, and structural integrity assessments to ensure therapeutic effectiveness. Purity characterization leverages HPLC, capillary electrophoresis, and mass spectrometry to detect and quantify impurities, ensuring product quality. Our services support both research-grade and clinical-grade nucleic acid therapeutics, providing the analytical foundation for successful drug development programs.
Ensure the quality and safety of your viral vector products with our comprehensive analytical testing platform designed specifically for gene therapy applications. Our viral vector analysis services cover all major vector types including AAV, lentiviral, adenoviral, HSV, and vaccinia vectors, providing complete characterization through five critical quality parameters. Identity testing confirms vector presence and serotype through DNA sequencing, Western blotting, and ELISA. Titer determination employs multiple methodologies including qPCR, ddPCR, and biological assays to accurately quantify infectious particles. Safety assessments encompass sterility, endotoxin, mycoplasma, and bioburden testing to ensure product safety. Potency evaluation combines vector copy number analysis, empty capsid rate determination, and in vitro expression studies to confirm biological activity. Purity analysis detects residual proteins, DNA, nucleases, and process-related impurities using state-of-the-art techniques including SDS-PAGE, mass spectrometry, and analytical ultracentrifugation. Our customized testing protocols adapt to specific vector types and application requirements, ensuring regulatory compliance and product consistency.
Complement your analytical testing needs with our specialized services that provide deeper insights into therapeutic mechanisms and safety profiles. Our expanded analytical portfolio includes comprehensive RNA profiling services utilizing next-generation sequencing technology to characterize transcriptome-wide expression patterns, identify biomarkers, and elucidate mechanisms of action. We offer specialized mitochondrial toxicity assays employing Seahorse technology and multi-parametric fluorescence analysis to assess cellular metabolism, oxidative stress, and mitochondrial function. These services integrate seamlessly with our core analytical offerings, providing holistic characterization of gene therapy products from molecular to cellular levels. Whether supporting early research, target validation, or safety assessment, these complementary services enhance our ability to deliver comprehensive analytical solutions that accelerate your development timeline while ensuring product quality and safety.
Our Analytical Excellence
- Comprehensive Testing Portfolio: Access the full spectrum of analytical methods required for complete characterization of viral vectors and nucleic acid therapeutics, eliminating the need for multiple testing vendors.
- Regulatory Compliance: All testing protocols follow ICH guidelines and regulatory requirements, with comprehensive documentation and certificates of analysis suitable for IND submissions and clinical trials.
- Advanced Instrumentation: State-of-the-art analytical platforms including mass spectrometry, next-generation sequencing, Seahorse analyzers, and analytical ultracentrifugation ensure accurate and reproducible results.
- Customized Protocols: Flexible testing strategies tailored to your specific product type, development stage, and regulatory requirements, with method development and validation services available.
- Expert Scientific Support: Dedicated analytical scientists provide technical consultation, data interpretation, and strategic guidance throughout your testing program.
- Rapid Turnaround: Optimized workflows and parallel processing capabilities deliver timely results without compromising analytical rigor or data quality.
Quality Assurance Framework
- GMP-Compliant Operations: Testing conducted in controlled environments with documented procedures, ensuring data integrity and traceability throughout the analytical process.
- Method Validation: Comprehensive validation of analytical methods including specificity, accuracy, precision, linearity, and robustness to meet regulatory expectations.
- Data Integrity: Secure data management systems with audit trails, electronic signatures, and controlled access ensure compliance with 21 CFR Part 11 requirements.
- Batch Release Testing: Standardized testing panels for routine quality control and batch release, with customizable protocols based on product specifications.
- Stability Studies: Long-term and accelerated stability testing programs to establish product shelf life and storage conditions.
- Comparability Studies: Analytical support for process changes, scale-up, and technology transfer with comprehensive comparability assessments.
