Nature Technology Corporation (NTC) is a leading developer of Biologics by Design. The newest generations of biologics are nucleic acids-based and rationally designed, including DNA pharmaceuticals and genetic vaccines
The promise of DNA vaccination is that the pharmaceutical compound (DNA) is safe and well tolerated, and can be introduced and expressed effectively in humans, creating the opportunity to synthesize and present antigens in a variety of ways, directly in human cells in vivo with minimal risk to the patient.
To date, however, successful DNA vaccines exist for use in animals, but humans have thus far proven problematic or refractile to effective genetic vaccination. In order for DNA vaccination to become highly effective in humans, major improvements are needed. For instance, it will be necessary to present the antigens in more than one form or occurrence (prime-boost), and co-stimulation will be required. Activation of the innate immune system is also a key to fostering strong, multi-arm immune responses.
The development of safe and effective DNA vaccines requires not only DNA backbones that are optimized for antigen expression, multi-mode presentation and innate activation. In addition, it will be necessary to use plasmid DNA molecules that are fully compliant with FDA Points to Consider, and which are optimized for massive scale-up and manufacturing by the most economical methods possible, for inexpensive humanitarian vaccination as mandated by CDC and WHO. This requires high efficiency fermentation and simplified downstream purification, resulting in highly purified and economical drug substances.
NTC’s DNA vaccines combine multi-mode presentation and vector backbone optimization with tunable innate activators, known as RNA elements (RNAe). All extraneous DNA sequences were eliminated from the plasmid backbone, fulfilling the Points to Consider, while increasing the specific potency. Optimized eukaryotic expression elements are combined with optimal prokaryotic elements (Kanamycin selectable marker or NTC's antibiotic-free selection system; minimal pUC origin of replication) for efficient fermentation and purification. NTC’s DNA vaccine vectors can be grown to record specific and volumetric yields (>2g/L) using NTC’s leading HyperGRO™ fermentation process. Finally, downstream purification is made easy through the introduction of autolytic processing, which eliminates the messy and caustic process of alkaline lysis. Ease of processing, smaller biomass volumes, and reduced waste streams contribute to purity and economy, resulting in the best overall combination of ingredients and processing that is possible in today’s pharmaceutical environment.
NTC’s vaccine partners generally have interests in developing immunity to infectious agents such as: hepatitis B and C; HIV-AIDS; influenza A and B; malaria; bioterror agents; cancers; addictive drugs; and fertility related antigens.
NTC assists its biopharmaceutical partners through: vector design and development (Gene Self-Assembly [GENSA™] technology); strain development (Genome Mass Transfer [GMT™] technology); process development (HyperGRO™ fermentation technology); and product development (new age biologics, DNA vaccines and recombinant proteins).
