Aldevron Releases GMP-Grade SpyFi™ Cas9 Nuclease
Product is the result of a partnership with Integrated DNA Technologies, and provides clinical-stage clients with a critical raw material
FARGO, ND (March 12, 2019): Aldevron, a leading contract development and manufacturing organization serving the biotech industry, announces the release of GMP SpyFi Cas9 Nuclease for clinical and commercial applications. SpyFi Cas9 Nuclease, the trade name for Aldevron’s research grade and GMP products, is the direct result of a partnership with Integrated DNA Technologies, Inc. (IDT). The advantages of SpyFi Cas9 Nuclease include reduced off-target effects combined with clinically relevant on-target activity. Aldevron manufactures and markets IDT’s HiFi S.p. Cas9 variant through a license agreement and has provided this research grade nuclease since December 2017. The release of GMP SpyFi Cas9 Nuclease provides researchers and scientists a consistent product from discovery through clinical and commercial manufacturing for gene editing programs.
“As a strong advocate for genomics research, IDT strategically partners with companies where we identify a real benefit for investigators,” said Mark Behlke, CSO of IDT. “Our Alt-R® S.p. HiFi Cas9 Nuclease was developed to benefit all applications where the highest level of precision editing is required, and medical applications are an important part of this market. Our partnership with Aldevron enables immediate access to the GMP version of this important new genome editing tool for Clinical Trials. Thanks to this partnership, we are able to lower barriers and increase access to important genomics tools, helping researchers progress clinical trials faster.”
This specific Cas9 protein variant resulted from a substantial amount of development of the wild-type Streptococcus pyogenes Cas9 sequence. This nuclease also functions well in ribonucleoprotein (RNP) delivery format and is compatible with ex vivo gene editing protocols. IDT’s partnership with Aldevron to make a GMP version of this unique enzyme will better serve the gene and cell therapy industry.
“We are excited by the release of GMP-grade, SpyFi Cas9 Nuclease,” says Michael Chambers, CEO of Aldevron. “Aldevron chooses its partnerships with the client in mind – we want to provide value at every turn. Our clients no longer need to qualify and manage multiple suppliers to support the various stages of their gene editing programs. This simplifies sourcing costs and reduces timelines with an “off-the-shelf” solution, which may help get these transformative treatments to patients even faster.”
GMP-grade SpyFi Cas9 Nuclease is available in 1 mg and 10 mg vials with a documentation package to support regulatory filings. In addition, a stability study to support the use of the product for clinical applications has been initiated due to client demand.
Aldevron serves the biotechnology industry with custom production of nucleic acids, proteins, and antibodies. Thousands of clients use Aldevron-produced plasmids, RNA and gene editing enzymes for projects ranging from discovery research to clinical trials to commercial applications. These products are critical raw materials and key components in commercially available drugs and medical devices. Aldevron specializes in GMP manufacturing and is known for inventing the GMP-SourceTM quality system. Company headquarters are in Fargo, North Dakota, with additional facilities in Madison, Wisconsin, and Freiburg, Germany. To learn more, visit www.aldevron.com.
Integrated DNA Technologies, Inc. (IDT) develops, manufactures, and markets nucleic acid products for the life sciences industry in the areas of academic and commercial research, agriculture, medical diagnostics, and pharmaceutical development. IDT has developed proprietary technologies for genomics applications such as next generation sequencing, CRISPR genome editing, qPCR, and RNA interference. Through its GMP services, IDT manufactures products used in diagnostic tests for many forms of cancer and most inherited and infectious diseases. IDT is widely recognized as the industry leader in custom nucleic acid manufacture, serving over 100,000 life sciences researchers and producing over 65,000 nucleic acids daily. IDT has its manufacturing headquarters in Coralville, Iowa, USA, with additional manufacturing sites in San Diego, California, USA; Leuven, Belgium; and Singapore. For more information please visit www.idtdna.com
Integrated DNA Technologies
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