Technology
The Archaeosome technology has been successfully tested in vivo for insulin, antibiotics, cancer treatment and other indications. Nevertheless, no commercial products are available since those lipids are not available in sufficient quality and quantity. During their time at TU Wien the members of NovoArc developed and patented an innovative production process that overcomes these limitations and yields high amount of lipids of high quality.
The production process was developed according to QbD guidelines as NovoArc’s Team has more than 10 years of experience in developing and transferring bioprocesses to the pharmaceutical industry.
To be introduced: Archaeosomes
Active pharmaceutical ingredients (APIs) are usually administered as injections, pills, creams, ointments or sprays. Liposomes are used for encapsulation of drugs and protect them from degradation or target them to a certain area in your body. Prominent examples for such a formulation in liposomes are the SARS-CoV-2 vaccines from Pfizer-BioNTech and Moderna.
Due to the low stability of conventional Liposomes, they can only be applied for parenteral (non-oral) purposes. Archaeosomes are Liposomes made of special and highly stable lipids. They are resistant against low pH, high temperature, oxidation and bile salts and thus suitable for the oral delivery of food supplements, medical devices and pharmaceuticals.
The major benefits of Archaeosomes are
- protection of the drug from degradation in the stomach
- stable long term formulation and thus increased shelf life at room temperature
- increased bioavailability of the drug after oral administration.
The Archaeosome technology has been successfully tested in vivo for insulin, antibiotics, cancer treatment and other indications. Nevertheless, no commercial products are available since those lipids are not available in sufficient quality and quantity. During their time at TU Wien the members of NovoArc developed and patented an innovative production process that overcomes these limitations and yields high amount of lipids of high quality.
The production process was developed according to QbD guidelines as NovoArc’s Team has more than 10 years of experience in developing and transferring bioprocesses to the pharmaceutical industry.
1. Lipid production
We developed a novel and efficient cultivation strategy for special Archaea, that produce highly stable lipids. As those organisms grow under extreme conditions (pH 2-3 and 75-85°C) a lot of know-how and experience is necessary to grow them in bioreactors. Our production process is reproducible and scalable and to reduce the size of the production facility we developed a continuous bioprocess according to QbD guidelines.
2. Lipid extraction
The extraction happens with organic solvents. Since this is not the most sustainable way, there are projects and experiments running to optimize this step.
Tetraetherlipids are made up from isoprenoid subunits and show high resilience to acids. Therefore they show the possibilty for protective coating of drugs, small molecules and/or vaccines.
3. Formulation
We pack different cargos (small molecules, peptides, antibiotics, etc.) into Archaeosomes. For the encapsulation process we use thin-film hydration, extrusion and microfluidics and we apply different lipid compositions depending on the intended release kinetics.
4. Characterisation
After formulation of the Archaosomes, we physically and chemically characterize them regarding encapsulation efficiency, size distribution, zeta potential and other relevant parameters. Furthermore we perform release kinetics in a simulated gastrointestinal tract as well as ex vivo and in vivo studies.
