Creative Biogene, the world’s leading biotechnology products and services provider, focusing on offering unique tools and services for gene research discoveries and product development, recently announces the release of a variety of q-PCR based — residual DNA quantification kit, it will help confirm the rationality of the purification process and ensure quality and safety of the final biopharmaceutical products.
With expertise in providing residual DNA testing services and related products to customers worldwide. Creative Biogene's advanced equipment, advanced technology and experienced staff can be used to detect residual DNA in a variety of samples, including monoclonal antibodies, recombinant proteins and viral products produced in cell culture. Creative Biogene is committed to offering reliable and accurate residual DNA results or related residual DNA quantification kits to ensure that it meets different needs in a timely and professional manner.
The residual DNA analysis offered by Creative Biogene allows compliance with the ICH Q6B guidelines for a range of GLP/GCP/GCMP compliant methods which are highly accurate, target-specific and sensitive. Real-time quantitative PCR and digital droplet PCR (ddPCR) technology can provide powerful quantitative functions to support process validation, monitor batch-to-batch differences and support GMP batch release, thereby helping to ensure a range of common host cell lines (HEK293, E. coli and CHO cells) meet the specifications of these process impurities.
Creative Biogene's global team of experts has experience in performing residual DNA testing on a variety of samples, including monoclonal antibodies, recombinant proteins, and viral products produced in cell culture. Services provided to meet customer needs for residual DNA testing include:
Ultra-sensitive detection of genomic DNA of various species (E. coli, mouse, CHO cells, yeast (Pichia pastoris), canine and Vero cells)
Detection of human genomic DNA
“We use both qPCR and ddPCR methods for residual DNA analysis to support biologics or cell and gene therapy development plan. Our experienced scientists will guide the projects, which can meet your specific needs and serve as research directors or project managers.” said Marcia Brady, the marketing director of Creative Biogene, “We are capable to perform routine work in accordance with ICH GMP/GCP/GLP guidelines, but can also provide non-regulatory R&D services. With a deep understanding of the latest regulatory developments, we can help you meet the authorization requirements of all regions of the world, and provide compliance data.”
About Creative Biogene
Creative Biogene, as a top-of-its-kind company that holds a leading position and is committed to accelerating the development of human science through biotechnology, offering innovative technologies, products, unique tools and services for research discoveries and product development. With more than 10 years of experience and in-house experts, Creative Biogene has become a well-recognized industry leader to support researchers worldwide.
Release ID: 88968315