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GMP grade plasmid DNA production is based on robust, single-use, TSE-BSE-free methods and occurs in our GMP suite, at a maximum scale of 50L. Delphi Genetics offers one-stop-shop CDMO service for plasmid DNA GMP supply, including: GMP compliant Process and QC Development GMP E.coli cell banking (Master and Working Cell Banks) GMP DNA Manufacturing using TSE-BSE free and Single-use process, based on QP approved Master Batch Record QC and Release by Qualified Person (QP) Full Quality Control complying with the European pharmacopea 5.14 will be performed: Content and purity by UV measurement (260/280 nm) Visual inspection Identity by restriction and DNA sequencing (full plasmid sequencing) Safety tests: Endotoxins, Bioburden/Sterility and Mycoplasma Residual RNA content Residual host protein Residual host genomic by Q-QPCR pH Topology Other tests can be performed on request. QP Released GMP Plasmid DNA is provided with TSE-BSE-free certificate and Certificate of Analysis.

R&D plasmid DNA will be produced in shake flask or in fermentor (up to 8L), in our R&D facility, and purified by classical method. R&D plasmids are provided Endotoxin-free.

Delphi Genetics provides customized plasmid DNA production services, from milligram to gram scale, for your R&D and clinical activities. We take care of your plasmid DNA material for viral vectors production and naked DNA-based gene therapy. Our service includes the supply of: R&D grade for non-clinical use, support for lead identification, clone screening, STABY evaluation. High Quality and GMP grade plasmid DNA for viral and non-viral (pre-)clinical activities.

For manufacturing recombinant proteins or DNA, plasmid instability is a significant concern. Typical biomanufacturing processes in prokaryotes require the use of bacterial plasmids as vectors carrying the gene of interest to be over-expressed. It has been demonstrated that the growth of plasmid bearing cells is significantly reduced relative to plasmid free hosts, simply because protein production represents a significant burden on cellular metabolism. This is of significant concern in the Biopharmaceutical Industry as both the yield and the production reproducibility of recombinant molecules are significantly lowered by that fact. Antibiotic resistance genes are the most common selectable markers used in fermentation processes to avoid plasmid free cells to overgrow the culture. However antibiotics are expensive compounds and they (or their degradation products) can contaminate the biomass or production product.

Several alternative strategies have been developed to minimize the risk that plasmid-free cells overtake the culture. One of the most promising of those strategies relies on the use of postsegretional killing genes (so called poison / antidote genes or selection modules) that induce host killing upon plasmid loss. Delphi Genetics has designed a novel and highly effective stabilization system, called Staby®, based on the use of selection modules naturally found in plasmids, bacterial chromosomes and bacteriophages. A selection module (like the ccd system used by Delphi Genetics) is typically organized as an operon and composed of two genes: the ccdB selection gene codes for a small stable protein which is toxic for E. coli, whereas the ccdA antidote gene codes for a small unstable protein that neutralizes the toxic protein both transcriptionaly and via protein-protein interactions. This unique system allows for the perfect stabilization of the plasmid without the use of antibiotics

With thousands of DNA vectors designed and constructed, Delphi Genetics is a Partner of choice to generate your plasmid of interest. Size does not matter, that's the strategy of cloning that drives the success of a plasmid construction. We perform the construction of your vector from strategy design to final plasmid production. We work with standard plasmid DNA as well as with large constructs, such as BAC and Cosmid. Our plasmid DNA construction service includes: Sequences analysis Design and strategy Gene Synthesis Cloning of PCR fragment DNA fragment assembling Site directed mutagenesis DNA sequencing Plasmid productionA new hope for Covid-19 treatment Delphi Genetics more than triples its production capacity and receives GMP certification. New Plasmid DNA production capacities now immediately available. Delphi to attend Phacilitate Leaders World in Miami, Jan 21-24 Delphi Genetics significantly expands its capacities for cGMP plasmid DNA GMP Certification for Plasmid DNA

Delphi Genetics offers the benefits of its proprietary Staby® technology through partnering opportunities. We intend to build high-value strategic collaborations for exploring the benefits of the Staby® technology in various DNA & Protein bioproduction settings. Partnering is a key component of our service delivery strategy. Delphi Genetics is open to consider any collaborative projects at all stages of development from R&D to the commercialization of your bioproduct. We seek collaborative partnerships with Biotech & Pharma companies that could enable us to contribute to your development on either a risk-sharing or out-licensing basis. In order to consolidate a long term relationship with its partners, Delphi Genetics is currently developing a brand new GMP production facility. This mid-scale capacity facility will join technology and flexibility to provide plasmid DNA and protein with high value for your clinical phases.

All E. coli strains can be adapted to the Staby® technology. This adaptation is linked to the insertion into the bacterial chromosome of the CcdB toxic gene. Based on our strong knowledge of E. coli genetic and our know-how in genetic engineering we can easily adapt the strain of your choice and genetically modify it for the Staby® technology. On the same basis, we can genetically modify the strain of your choice to introduce mutation, deletion or to restore activity of certain gene. We can also introduce new gene to give new characteristic to your strain. One example would be to allow your strain of interest to grow and use new or unusual substract. All these modifications are finalized without any genetic trace

We are continuously improving and developing our Staby® technology to provide new adaptation proposing the best solution to our Customer. The Staby® technology has been adaptated in different fields and can be proposed on a tailor made solution basis or on a service basis. The Staby® technology applications actually available are the following. Feel free to contact us for other request

Traditionally clone selection was based on the disruption of a genetic marker (e.g. blue and white screening based on the disruption of the LacZ gene), plasmid retention was based on antibiotic resistance genes. The development of vectors employing selection modules circumvents these issues and permits growth of bacteria harbouring insert-bearing plasmids only. Typically, the vectors used in these systems express a gene product that is lethal to certain bacterial hosts. The lethal gene is inactivated by insertion of a segment of foreign DNA and therefore, toxicity is relieved. The most efficient technical solution remains the killing of bacteria harbouring an insertless vector, or the selection of bacteria harbouring the recombinant vector, the so-called positive selection. The ccdB technology developed by Delphi Genetics has proven to be a successful approach for constructing positive selection vectors

Because the stabilization relies on the presence of only two genetic elements, one on the plasmid the other in the expression strain, the stabilization technology is readily adaptable into any existing E.Coli based expression platform. Delphi Genetics can customize any vectors and strains by adding the stabilization cassette into the vector and the selection gene into the chromosome of the chosen expression strain. Furthermore Delphi Genetics has developed a comprehensive licensing policy for those who would wish to integrate the stabilization system into an existing platform.

Modern DNA engineering requires efficient and robust molecular tools. The Staby® Operating System, developed by Delphi Genetics is an original set of bacterial strains and vectors integrating unique patented technologies. The use of these products and technologies allows researchers to reach their goal faster and more efficiently. These technologies can be used in a project of any scale (from laboratory scale to industrial processes). The Staby® Operating system is very flexible and its elements can be integrated into your favorite tools, allowing you to add the power of the Delphi-Genetics technologies into your own platform.

High-Quality grade plasmid DNA production is based on robust, single-use, TSE-BSE-free methods and occurs in our GMP suite, at a maximum scale of 50L, after Delphi's process performance assessment. Full Quality Control complying with the European pharmacopea 5.14 will be performed: Content and purity by UV measurement (260/280 nm) Visual inspection Identity by restriction and DNA sequencing (full plasmid sequencing) Safety tests: Endotoxins, Bioburden/Sterility and Mycoplasma Residual RNA content Residual host protein Residual host genomic by Q-QPCR pH Topology Other tests can be performed on request. High quality Plasmid DNA is provided with TSE-BSE-free certificate and Certificate of Analysis.