We dry biologics
Ambient drying is a new way of drying biologics that eliminates heat stress, heat degradation and the need for elevated temperatures. Unlike other pharmaceutical drying systems, our ambient drying system uses Mass Transfer, but not Heat Transfer, to dry delicate biologics from vaccines to protein therapeutics as particle-engineered powders that are thermostable and also highly suitable for novel administration routes.
API drying technology – into the future
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LaminarPace has enabled the formulation of a wide range of biomolecules including mRNA, proteins, peptides, antibodies, lipids and enzymes. The system has worked successfully with a range of excipients, and adjuvants and antigens.
Ambient drying offers advanced thermostability outcomes. Ziccum has worked with a wide range of regulatory definitions of thermostability including ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) and WHO guidelines.
LaminarPace’s particle-engineered powders enable the formulation of a number of novel administration routes beyond injection. Ambient drying allows greater control over key properties of the dried particles, such as particle size. Its particle-engineered powders are fast- dissolving and well-suited to administration via inhalation, microarray patches, topical application through the skin or reconstitution for intravenous administration.
“Everyone was always looking for ways to carry out an efficient drying process without using heat.
That is exactly what LaminarPace does. For pharmaceutical formulation scientists this is a dream machine.”
- Fabrice Rose, Scientific Director Ziccum
Step inside LaminarPace
So how exactly does it work? LaminarPace creates an efficient drying process by generating mass transfer, rather than heat transfer. This happens directly after evaporation and removes the need for elevated temperatures. Mass transfer is a highly efficient drying method. Our optimization tests demonstrate that following drying less than 2% of absolute humidity is left inside LaminarPace’s drying column.
To best understand the process, let’s follow the drying path of a single droplet of biomolecule.
Follow the flow - from liquid droplet to dry particle
Follow the drying path of a single droplet as it is dry-formulated inside LaminarPace.
A fine vaporized spray of liquid solution droplets is released in a pulse at room temperature and great speed from the nebulizer at the top of LAPA’s inner drying column
As the droplet circles downward fast-moving laminar flows of nitrogen gas circle around it
These laminar flows quickly evaporate the outer mass of moisture that envelops the droplet’s API
This moisture is transferred through LAPA’s membrane to the system’s outer column, where a countercurrent of more turbulent nitrogen removes it
The remaining particles of biologically active dry powder are collected in a powder collector at the bottom of the drying column - their moisture removed; their API intact