Norgen Biotek Corporation



The Company:
Norgen Biotek was founded in 1998 by Professor Yousef Haj-Ahmad. The company is located in a new, 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. ISO 9001 certification indicates our continuing commitment to our quality management system, while certification to ISO 13485 is a requirement for the manufacturing of commercial medical devices including in vitro diagnostic kits. Our new ISO 15189 accreditation emphasizes our commitment to quality in our laboratory and R&D services. Norgen’s scope of accreditation for ISO 15189 will allow the company to provide high quality, competent molecular diagnostic testing for research purposes and clinical trials. Norgen was recently recognized as one of Canada's Top 10 Life Science Companies. For general business inquiries please click here.

The Technology:
Norgen holds more than a 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 fuelling 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". If you would like to learn more about Norgen’s unique technology, please click here.

The Products:
Norgen has successfully exploited part of its IP to develop over 70 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 offers a full line of PCR reagents, buffers, molecular weight ladders and plastics/filtration devices. To receive additional information about Norgen’s products please click here.

Diagnostics:
Norgen recently launched over 30 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. Initially 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. A large number of nucleic-acid based diagnostic kits are also in the product pipeline. To learn more about Norgen’s diagnostic kit development, please click here.

Manufacturing Capability:
Norgen not only develops & manufactures its own kits but also OEM, 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. To learn more about Norgen’s manufacturing capability, click here.

cGMP:
Our 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. To learn more about Norgen’s cleanroom and aseptic filling services, please please click here.