Custom Products & Services

In addition to Synvolux’ products for the transfection of DNA, RNA and proteins, Synvolux also offers several custom products and services. These include SAINT-Solid: lyophilized pure SAINT lipids allowing our customers to produce SAINT containing liposomes according to their own recipes. Furthermore, SAINT-Vivo has been developed as an efficient in vivo delivery agent for DNA vaccines that have been shown to elicit potent T and B cell responses. Customers may also provide targeting reagents (e.g. antibodies) and cargo (e.g. siRNA) for the production of custom liposomes (SAINT-O-Somes) for in vitro and in vivo applications. If you are looking for GMP-compliant transfection reagents, please contact us.  Click the relevant tabs below for more information on these custom products and services.

For clients with difficult-to-transfect cells or not enough time or resources on their hand, Synvolux also offers custom screening and optimization services to identify the most suitable transfection reagent from Synvolux’ library of >100 distinct transfection reagents in combination with DNA, siRNA, mRNA, or protein/peptides. Feel free to contact us to discuss your needs and wishes.

Lyophilized pure SAINT lipids

SAINT-Solid

In vivo transfection reagent

SAINT-Vivo

SAINT-O-Somes
Progress in drug delivery: SAINT-O-Somes

Synvolux has a long-standing experience in the formulation and production of transfection reagents for macromolecules such as DNA, RNA, and proteinaceous material.

SAINT-O-Somes, invented by Synvolux and patent-pending, allow the targeted delivery of biomolecules in vitro and in vivo to specific cell types or tissues. For example, SAINT-O-Somes targeted to VCAM-1 and E-selectin have been demonstrated to selectively and functionally deliver siRNA into inflammation-activated endothelial cells in vitro. What’s more, Kowalski et al. demonstrated endothelial-cell-specific delivery of siRNA by targeted Anti-VCAM-1 SAINT-O-Somes in vivo, resulting in downregulation of inflammatory genes in inflamed mouse kidney.

This new class of synthetic drug-delivery devices is biodegradable, targetable and biocompatible. Targeted SAINT-O-Some technology may significantly reduce clinical effective dosing, minimize off-target effects, and thereby reducing adverse effects in patients. For more information on how SAINT-O-Somes are or can be used, feel free to contact us.

Synvolux Therapeutics is continuing its effort to make resources available to bring targeted drug delivery technology towards a relevant clinical application. Since SAINT-O-Somes provide a platform technology and possibilities are numerous, researchers with co-development proposals are invited to share ideas.

GMP grade transfection reagents
GMP-grade transfection reagents

For the development of innovative new therapies based on the use of gene expression vectors, siRNA or miRNAs, there is an urgent need for safe, non-viral, GMP-grade transfection reagents. Therefore, Synvolux has put much effort in optimizing the synthesis, production processes and manufacturing conditions to develop a cost-effective transfection reagent that is readily amenable to high-volume, GMP-grade production for clinical use. One of the unique properties of SAINT lipids that distinguishes it from other lipids, is its heat tolerance (see the picture below).

Currently, heat-sterilized, GMP-grade SAINT lipids are being used in a clinical trial at the Radboud University Medical Center (Nijmegen, the Netherlands) for dendritic cell vaccinations to boost graft-versus-tumor immunity. Preceding work describing the benefits of SAINT lipids for this and other clinical studies is described by Roeven et al.

The specifications of GMP-grade SAINT lipids:

  • Purity                          > 96%
  • Endotoxin                  < 5 EU/ml
  • RNAse activity          < 0.1 mU/ml

Bioburden

  • Cetrimide                  < 5 CFU/ml
  • R2A                            < 5 CFU/ml
  • Sabouraud                < 5 CFU/ml
  • Caso                           < 5 CFU/ml
  • Endo                          < 5 CFU/ml

* GMP-grade means: Production of the transfection reagent (SAINT-RED) under pharmaceutical conditions. To be approved by EMEA or FDA after inclusion of the active pharmaceutical ingredient (siRNA) delivered by the customer.

GMP-grade SAINT-RED can be heat sterilized without detectable loss of transfection efficacy (transfection of CHO-K1 cells with GFP-encoding plasmid):

SAINT and competitor following heat-sterilization

SAINT-Vivo for in vivo applications
SAINT-Vivo enables in vivo transfection and vaccination

SAINT-Vivo is an optimised version of the SAINT-18 cationic lipid, which has been used by several groups of researchers for in vivo application as a delivery agent for DNA.

The group of C.N.Kuo et al. has shown non-inflammatory corneal transfection in rats. In one of their publications they demonstrate inhibition of corneal neovascularization with a plasmid encoding pigment epithelium-derived factor (p-PEDF), delivered by SAINT-18, in an experimental model of rat corneal angiogenesis. Yet another publication examines the combination of a recombinant humanized monoclonal antibody to VEGF with p-PEDF/SAINT-18. Together, this work demonstrates that a combination of antibody and gene therapy using SAINT-18 may have potent and prolonged anti-angiogenic effects, thus providing a potential new therapy for severe complications of ischaemic ocular diseases caused by neovascularisation.

In the field of DNA vaccination, Endmann et al. have shown SAINT-mediated delivery of a gene expression vector coding for hepatitis B virus surface antigen (HBsAg). Upon intradermal injection of this DNA vaccine, a dose-dependent antibody response was elicited in mice. Another publication by the same group demonstrated that when administered in combination with SAINT-18, the expression vector is found in significantly larger amounts in draining lymph nodes compared to the same vector without SAINT-18. Furthermore, the use of SAINT-18 resulted in greater antigen expression, and the combination of SAINT-18 with the gene expression vector was well tolerated in mice and rats. In a study in pigs, Endmann et al. show that a SAINT-18 formulated DNA vaccine at a relatively low dose elicits an immune response similar to a normal dose of a commercial, licensed aluminum hydroxide-adjuvanted protein vaccine. After three vaccinations, the SAINT-18 formulated DNA vaccine induces a specific antibody response at a level considered protective. In conclusion, a SAINT-formulated DNA vaccine may provide a safe and effective alternative to current hepatitis B vaccines.

A research group at the university of Hannover has shown the application of SAINT-18 as a delivery agent in therapeutic DNA vaccination therapy against equine melanoma. Grey horses vaccinated thrice with DNA vectors  encoding equine IL-12 and IL-18 display a significant decrease in tumour burden.

In conclusion, these animal studies demonstrate that SAINT-18 is an excellent delivery vehicle for gene expression vectors for in vivo applications, including DNA vaccines that elicit effective immune responses against viruses and cancer.

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