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About Norgen

The Company

Norgen Biotek was founded in 1998 by Dr. 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 Illumina Propel certified fully-integrated Canadian biotechnology company focusing on developing products for sample collection, sample preparation and sample detection, as well as providing comprehensive research services to the scientific community. 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. Our Illumina Propel certification emphasizes our proficiency with Illumina Next-Generation Sequencing (NGS) to support genetic and genomic research and provide high quality services to our customers.

Norgen's Technology

Norgen holds more than thirty 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, microRNA, proteins and exosomes 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".

Manufacturing Capability, Contract Manufacturing and OEM

Norgen develops and manufactures all of our products, including isolation and purification kits, sample collection and preservation devices, molecular diagnostic kits and NGS kits. We not only manufacture all the reagents and solutions for these kits, we also manufacture the spin columns associated with these kits. Norgen has a fully equipped manufacturing facility, including an ISO class 5 certified cleanroom used for high capacity liquid filling. Norgen also has tremendous expertise in OEM and contract manufacturing of kits and reagents for the molecular biology and diagnostics markets. This includes customized manufacturing of full purification/isolation kits, sample collection and preservation devices, as well as molecular biology reagents including buffers and RNA/DNA standards. Norgen’s contract manufacturing services are catered to each individual’s needs, and we are 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.

cGMP

All of Norgen’s products are manufactured according to the ISO 13485:2016 standard, which meets or exceeds cGMP compliance. From our fully validated equipment and manufacturing premises to our highly trained personnel, we meet all the requirements of GMP. All of our manufacturing processes are strictly controlled by SOPs, ensuring batch to batch consistency and full traceability for all products manufactured in our facility. In addition to the manufacture of own products and medical devices, we also offer contract manufacturing to the life science and medical device community.