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Aldevron Releases GMP-Grade SpyFi™ Cas9 Nuclease

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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.