The team of Anders Ståhlberg (Sahlgrenska Cancer Center at University of Gothenburg) in collaboration with ArcticZymes has today published an article in International Journal of Molecular Sciences.
The article, titled “Preamplification with dUTP and Cod UNG Enables Elimination of Contaminating Amplicons”, describes how the use of dUTPs in combination with Cod UNG in targeted preamplification can provide a simple and efficient solution for eliminating carry-over contamination.
Carry-over contamination can pose significant challenges when analysing small samples of DNA and RNA where preamplification is required. By introducing contamination clean-up with Cod UNG prior to preamplification with dUTP in the work-flow, these challenges can be minimized.
ArcticZymes has secured its first supply agreement for the utility of Salt Active Nuclease High Quality (SAN HQ) in the cGMP manufacturing of viruses for gene therapy. ArcticZymes’ Novel SAN HQ enzyme offers gene therapy and vaccine customers a more cost effective and technically superior solution for removing contaminating DNA during the manufacturing process of therapeutic viruses. This represents a critical and challenging step in the manufacturing process where long-established alternative technologies are costlier and technically suboptimal. Cost and technical inefficiencies represent key challenges for the wider adoption of gene therapy. ArcticZymes SAN HQ allows customers to overcome these hurdles in one part of the complicated workflow in the manufacturing of cGMP grade therapeutic viruses. cGMP (current Good Manufacturing Practices) is relevant when a drug leaves the laboratory and enters into production, where scale, consistent quality and robustness are key requirements.
The undisclosed customer is a leading pioneer in the rapidly growing gene therapy market. Unlike traditional therapeutics, gene therapy provides realistic opportunity to cure devastating childhood genetic diseases and cancers by using viruses to modify DNA within a patient’s cells.
Commercial value of individual deals is anticipated to be in the 1-3 MNOK range per annum as customers lock down their large-scale cGMP manufacturing processes. The ability to produce viruses in large-scale is a critical factor to ensure that enough virus can be produced to support clinical trials and approved therapeutics.
“Securing our first supply agreement to support cGMP manufacturing of gene therapy viruses via our novel technologies is a milestone for ArcticZymes. We are excited and privileged that ArcticZymes can play a part in supporting our customers who are pioneering gene therapy solutions to cure devastating and life -threatening diseases.” says Jethro Holter, Managing Director ArcticZymes, AS.
ArcticZymes presents rSAP Glycerol-FREE and Cod UNG Triton-FREE. rSAP Glycerol-FREE becomes the fourth member of ArcticZymes’ glycerol-free product family, whereas the launch of Cod UNG Triton-FREE marks the first step towards maintaining a completely EU REACH compliant product portfolio after Triton X-100 becomes subject to authorisation in January 2021.
Glycerol-free formulations enable efficient lyophilization. Lyophilization of enzyme products helps overcome logistical challenges such as cold-chain distribution and storage, and limited product shelf-lives. Glycerol-free formulations are also preferable in highly automated processes, where the viscosity of high-glycerol formulations may pose challenges.
Triton X-100, a commonly used detergent across the life science industries, was included in Annex XIV of the EU REACH regulation in June 2017, with a “sunset date” set to January 4th 2021. Companies in the EU/EEC that wish to continue using Triton X-100 after the sunset date, will have to apply for authorisation unless the particular use is exempt. By launching Cod UNG Triton-FREE, ArcticZymes demonstrates its commitment to maintaining a REACH compliant product portfolio, and facilitates a smooth transition for our existing Cod UNG customers.
ArcticZymes’ Proteinase is a novel heat-labile enzyme easily inactivated after use. Gentle inactivation of the enzyme enables broader compatibility in the development of kits and products serving the In Vitro Diagnostic (IVD) and molecular research market segments.
In developing the Proteinase, ArcticZymes worked with collaborators and customers to demonstrate its key benefits in streamlining workflows in research and product development. In particular, ArcticZymes has collaborated with Associate Professor Anders Ståhlberg, a leading authority in single-cell biology and liquid biopsies at the Sahlgrenska Cancer Center in Gothenburg. Ståhlbergs’ lab demonstrated the utility of ArcticZymes Proteinase to solve technical challenges in the isolation of low abundance DNA samples from precious biopsies or biological samples, prior to DNA analysis by PCR and Next Generation Sequencing.
“The properties of ArcticZymes’ Proteinase open up new possibilities to analyze nucleic acids in ways that has not been possible before. Currently, we are exploring a number of applications in the areas of liquid biopsy and single-cell analysis’’ says A. Ståhlberg.
The new enzyme is supported by intellectual property, which ArcticZymes will convey to its customers. By adopting the enzyme, customers can take advantage of its benefits to improve existing kits and in the development of new products or technologies.
With respect to potential, the new enzyme will open ArcticZymes ability to penetrate the liquid biopsy and sample preparation markets within our existing customer base as well as new IVD customers we are not reaching today. The technical advantages ArcticZymes Proteinase offers will resonant well with IVD companies developing non-invasive tests based on cancer biomarkers. As with any new enzyme launch, it will take 1-4 years for our customers to commercialize their technologies or IVD assays containing the enzyme. Longer-term we can expect Proteinase sales similar to our leading products today. The incremental addition of new synergist products to ArcticZymes portfolio will continue to increase our relevance to customers across the market segments we serve.
“ArcticZymes Proteinase is a new class of enzyme for the company and provides synergy with our other enzyme product offerings. The enzyme enables ArcticZymes to provide a new component to the liquid biopsy and sample preparation market. We are excited to offer another unique innovation and look forward to supporting our customers in exploiting the enzymes unique features in their product developments.” says Jethro Holter, Managing Director ArcticZymes, AS.