Norgen Biotek Corp.
Norgen Biotek Corp. is dedicated to providing our customers with first class sample preparation kits for RNA, microRNA, DNA and protein purification, clean-up and concentration and to provide dedicated and expert support services to our customers and partners worldwide. Our ISO 15189 accreditation emphasizes our commitment to quality in our laboratory and R&D services. Norgen’s scope of accreditation for ISO 15189 allows the company to provide high quality, competent molecular diagnostic testing for research purposes and clinical trials. In addition, Norgen has received numerous awards over the years, including being recognized as one of Canada`s Top 10 Life Science Companies.
Norgen Biotek was founded in 1998 by Professor Yousef Haj-Ahmad. The company is located in a 24,000 square foot state-of-the-art facility in Thorold, Ontario, Canada a few blocks from Brock University. Norgen is an ISO 9001, ISO 13485 and ISO 15189 certified fully-integrated Canadian biotechnology company focusing on sample preparation. Norgen’s ISO 9001 and ISO 13485 certifications indicate our commitment to manufacturing and selling high quality products, as well as our commitment to continually improving our company, our products and our quality management system.
Norgen holds more than two dozen issued and pending patents. Norgen has developed a unique platform technology based on a proprietary resin/matrix with many applications including the purification, concentration and clean-up of DNA, RNA and proteins from various specimen types. The efficient purification of these macromolecules is often the first step in diagnostics and in hundreds of molecular biological applications fueling discovery for genomics and proteomics. The novelty of this technology has been recognized by the National Research Council by awarding Norgen the prestigious 'Innovation Leader Award for 2003'.
Norgen has successfully exploited part of its IP to develop over 150 sample preparation kits for RNA, DNA, and protein purification for research purposes. These kits include the leading kits in the world for the isolation and purification of total RNA and microRNA from various samples, as well as novel multi-analyte kits that allow for the sequential isolation of RNA, DNA and proteins from the same sample using a single column with no sample splitting. Norgen also has an extensive line of products for the purification of RNA and DNA, including cell-free circulating nucleic acids, from liquid biopsy samples including urine, plasma, serum and blood. Norgen also offers a full line of PCR reagents, buffers, molecular weight ladders and plastics/filtration devices.
Norgen recently launched over 100 kits for nucleic-acid based diagnostics. This new basket of products includes kits for the diagnosis of human pathogens from both urine and plasma/serum, kits for the diagnosis of food-borne pathogens and kits for the diagnosis of plant pathogens. These kits are being offered for research use only, and are ideal for use in surveillance of drug resistant pathogens, epidemiological studies, field surveillance of pathogens, and surveys. In terms of diagnostic kits for the human pathogens, particular attention has been paid to the development of kits based on non-invasive sample preparation. Non-invasive sample collection offers a number of distinct benefits for diagnostics, and therefore the first kits which Norgen plans to obtain regulatory approval for are the urine-based pathogen detection kits.
Norgen not only develops and manufactures its own kits but also OEMs, markets and sells these kits. Norgen has a fully equipped manufacturing facility, including an ISO class 5 certified cleanroom to allow for aseptic liquid filling. Norgen Biotek is fully committed to supplying high quality products and services. We offer best-in-class products, fast delivery time, and personable, highly competent, and unparalleled services.
Our state-of-the-art manufacturing facility recently underwent a number of upgrades, and we currently maintain a static and operational ISO class 5 clean room environment for Grade C aseptic filling. Efforts are now underway to validate the room and filling process to comply with cGMP Grade A standards to meet our need to manufacture diagnostic kits, and allow aseptic filling of drugs for pre-clinical and clinical trial under contract.
The team at Norgen Biotek Corp. is committed to providing our customers with first class sample preparation kits for RNA, DNA and protein purification, clean-up and concentration for use in research applications as well as diagnostics, and to provide dedicated and expert support services to our customers and partners worldwide. Norgen is also dedicated to providing high quality, competent molecular diagnostic testing for research purposes and clinical trials.
Norgen Biotek Corp will achieve this through our commitment to:
- Providing high quality, first-class, cost effective products
- Continuous improvements to our quality system, our manufacturing operations, our business practices and our products
- Continuous improvements to customer satisfaction by maintaining a customer feedback process to capture and analyze customer needs and feedback on product effectiveness
- Identification, resolution, correction and prevention of quality problems
- Educating and training employees to accomplish quality goals
- Maintaining our Quality Management System so as to conform to ISO 13485:2016, ISO 9001:2015, ISO 15189:2012, and comply with the Canadian Medical Devices Regulations (SOR/98-282), as amended