In biopharmaceutical production, controlling Host Cell DNA levels is critical to ensuring the safety, efficacy, and regulatory compliance of your products. Regulatory agencies such as the FDA, EMA, and pharmacopoeias (USP, EP) impose strict limits on residual DNA content and fragment size.
At Clean Cells, we provide advanced GMP-certified testing solutions to support you meet these requirements with precision and reliability.
GMP assays for Host Cell DNA detection and quantification
The quantification of residual DNA is a key step in the quality control of biological products, such as vaccines, monoclonal antibodies (mAbs), and gene therapy products. It aims to accurately measure the remaining Host Cell DNA in your product and ensure its safety, in compliance with FDA recommendations (<10 ng/dose).
Our GMP-certified assays are based on SYBRGreen qPCR methods, which are validated according to ICH Q2 guidelines to guarantee highly sensitive and specific detection. These assays comply with the latest regulatory standards, including the European Pharmacopoeia § 2.6.35 and USP <509>.
In addition, our solutions offer a broad species coverage, allowing the detection of residual DNA from various host cells, including human, canine, mouse, Vero cells, duck, insect, CHO, avian, and bacterial sources. This versatility makes our testing methods adaptable to a wide range of biopharmaceutical applications, securing the safety and quality of different biologics.
GMP DNA Sizing Determination
While quantifying residual Host Cell DNA is crucial to ensuring product purity, it is equally important to characterize the size of these DNA fragments to comply with regulatory expectations. Our GMP DNA sizing determination assay provides precise measurement of DNA fragment length in biologics, ensuring that no residual DNA fragment exceeds 200 base pairs, as recommended by the FDA.
Particularly suited for products derived from Human, CHO, and Vero cells, this analysis plays a key role in mitigating biological risks and strengthening the safety profile of your biopharmaceuticals.
To provide highly accurate results, our DNA sizing determination relies on digital PCR technology, a cutting-edge method known for its sensitivity and reliability. This assay is fully compliant with European Pharmacopoeia § 2.6.35 and USP <509>, ensuring alignment with the latest regulatory expectations.
Additionally, our GMP DNA sizing assay is complementary to Host Cell DNA quantification, offering a comprehensive approach to residual DNA analysis. It enables precise ratio determination across critical size ranges, including 120 base pairs, 250 base pairs, and 350 base pairs.
By combining Host Cell DNA quantification and DNA sizing determination, Clean Cells provides a complete and reliable solution to help you secure your bioproduction and maintain regulatory compliance.
Ensure Compliance and Product Safety with Clean Cells
With our expertise in residual DNA analysis, Clean Cells supports your bioproduction with reliable, GMP-certified assays tailored to your specific needs.
By integrating cutting-edge quantification and sizing determination solutions, we help you maintain the highest standards of quality, safety, and regulatory compliance.
Get in touch with our experts to learn more!