Press Release

Creative Diagnostics, a reagent supplier and developer focused on biologics quality control, announces the launch of its new Animal-Derived DNA Residue Assay Kits (qPCR) for researchers to rapidly detect and quantify residual animal DNA in various samples. These kits offer exceptional specificity and sensitivity, ensuring product safety and compliance in the biopharmaceutical and biotech industries.

Creative Diagnostics has developed a range of host cell DNA assay kits for use in specific cell line expression systems based on rapid qPCR technology, which can be used for highly sensitive, highly accurate detection and quantification of host cell DNA contamination. These residual DNA molecules present in the human body along with biological products can lead to increased risk of carcinogenesis, infection and immunomodulation. The World Health Organisation (WHO) and the European Union (EU) allow residual DNA levels of up to 10 ng/dose and the US Food and Drug Administration (FDA) allows residual DNA levels of up to 100 pg/dose. To meet these requirements, methods with high sensitivity and accuracy are needed to detect and quantify low levels of DNA.

The newly released Animal-Derived DNA Residue Assay Kits utilize advanced qPCR technology to provide rapid and reliable results. By targeting specific animal DNA sequences, these kits enable precise detection and quantification of even trace amounts of residual animal material, minimizing the safety risks of animal-derived components and safeguarding public health. These innovative Animal-Derived DNA Residue Assay Kits, such as the Porcine DNA Residue Assay Kit and the Bovine DNA Residue Assay Kit, are essential tools for ensuring the integrity of biological products such as therapeutic proteins, vaccines, and antibodies.

For example, the Bovine DNA Residue Assay Kit (Cat. No. DDNA-017) is a PCR-based fluorescence probe assay for the quantitative detection of bovine DNA residues in biological samples. Offering high sensitivity and specificity, the kit can rapidly detect bovine DNA at the femtogram level. It includes a bovine DNA quantitative reference standard and is paired with the Creative Diagnostics MagIso™ Animal-derived Biomaterials Residual DNA Extraction Kits (Magnetic Beads) for optimal sample preparation. This assay is ideal for the accurate measurement of bovine DNA residues in various biomaterials, such as membranes, patches, and decellularized matrices.

The ResDetFast™ Human DNA Residue Assay Kit (Cat. No. DDNAF-018) is a rapid and sensitive qPCR assay for the quantitative detection of residual human DNA in biological products. It employs PCR primers and probes targeting conserved human genome sequences and includes a ready-to-use human DNA reference standard. When combined with the Creative Diagnostics Nucleic Acid Extraction or Purification Kit, the assay can detect femtogram levels of human DNA in just 1.5 hours. This kit is specifically designed for the quantitative detection of human host cell DNA in intermediate, semi-finished, and finished biological products.

For more information on custom Animal-Derived DNA Residue Assay Kits (qPCR) or project-specific Host Cell DNA Assay Kit development services, please visit https://qbd.creative-diagnostics.com/products/animal-derived-dna-residue-assay-kits-qpcr-2791.html.

About Creative Diagnostics

Creative Diagnostics is a global leader in the development and manufacturing of innovative tools and reagents for bioprocess impurity analysis. The company offers a comprehensive portfolio of solutions to support researchers in the quality control of biologics and provides biopharmaceutical quality, purity and safety assays, analytical methods and applications for the biotechnology and biopharmaceutical industries.

Organisation Profile:
Creative Diagnostics is a leading manufacturer and supplier of antibodies, viral antigens, innovative diagnostic components, and critical assay reagents. We provide contract biologic R&D and manufacturing services to the diagnostic manufacturers along with GMP biologics manufacturing for the biopharmaceutical market. Our goal is to be a trusted source for all your assay development and manufacturing needs.