A new formulation and drying technology for biotherapeutics could solve key challenges in delivery and stability for today’s mNRA platform, unlocking and expanding its potential.
Following its rapid development for Covid-19 vaccines, mRNA has transformed the pharmaceutical industry forever.
Enabling new dosage forms and stability for mRNA
However, mRNA components are very fragile and can only be stored at cryogenic temperatures and administered via injection. A new technology has now been developed that transforms mRNA/ LNP by formulation and drying into easily manageable powder – unlocking a range of new possibilities.
The robust, particle-engineered powder can be easily reconstituted back into solution in the clinic, for injection, or applied for novel dosage forms such as inhalation or transdermal patches.
Smart chemical engineering using mass transfer
CEO Ann Gidner says the process of transforming the pharmaceuticals from liquid into a stable amorphous powder is conducted using smart chemical engineering. After specific formulation, a drying column removes the solvent molecules — typically water — in a rapid, one-step, high-yield and low-cost process with little or no degradation.
Existing drying techniques involve freeze-drying or spray-drying using heat, both harming the activity of mRNA/LNP. Ziccum’s LaminarPace technology instead uses a mass transfer principle to create more stable, thermostable and user-friendly forms of mRNA and biotherapeutics. “This is a complete game-changer to the industry, this is not possible with any other technology,” insists Gidner.
This is a complete game-changer to the industry, this is not possible with any other technology.
Overcoming the key challenges to mRNA therapy
mRNA enabled efficient Covid vaccination, thanks to using LNP (lipid nanoparticles) as a key delivery system. Via mRNA, a genetic code is delivered into the patient’s body enveloped in LNPs and translated into an active remedy. Gidner argues that dry formulations would enable mRNA to fulfil its potential. Development of a broad range of treatments — from cancer and flu vaccines to prophylactic vaccines would be possible. “By solving the inherent limitations of mRNA, you would open up completely new treatments and our technology can achieve this — it enables delivery and solves stability.”
LaminarPace has been tested successfully by Ziccum using commercially available mRNA. Now, two leading pharma and biopharma corporations have signed agreements for evaluation studies.