Nanexa AB

What is

WHAT IS PHARMASHELL®?

PharmaShell® is an advanced formulation technology enabling the development of Long-Acting Injectable therapies for conditions from hematology and oncology to cardiovascular disorders, psychiatry and more.

PharmaShell® enables the controlled release of APIs into the bloodstream – increasing compliance, reducing costs and ultimately enabling smarter care regimens.

How

HOW DOES PHARMASHELL® WORK?

PharmaShell® covers drug microparticles at the atomic level in a highly protective, extremely thin film coating (approximate 50 nm) of slow-dissolving nontoxic inorganic oxides.

By customizing both the thickness and composition of this coating we can control the speed at which the API is released into the bloodstream over days, weeks or months.

The controlled release is steered by modulating the coating thickness, the composition of the coating and process parameters. We are currently primarily using nontoxic aluminum oxide and zinc oxides in the ADL coating.

Biologics

HOW DOES PHARMASHELL® WORK WITH BIOLOGICS?

PROTEINS

In preclinical tests protein has proven applicable for PharmaShell® formulation.

In a lysozyme protein model enzyme activity was unaffected and there was a sustained in vitro release of coated protein.

PEPTIDES

In preclinical tests peptides have proven applicable for PharmaShell® formulation.

In an in vivo mouse study a water soluble peptide was coated with PharmaShell® with a high drug load (>70% API). Whilst there was rapid clearance of the uncoated API, the initial release of the coated peptide showed a small initial burst release, Cmax/Css about 10×, then controlled release continuing for the full duration of the study: 8 days.

ALD

WHAT IS ALD (ATOMIC LAYER DEPOSITION)?

For professionals in advanced materials manufacturing Atomic Layer Deposition has long been prized as a precise, conformal and customizable coating that protects and extends the life of many of the world’s most advanced products. So, what if ALD could bring the same advantages to pharmaceutical formulation?

Nanexa are pioneers in using ALD coatings on Active Pharmaceutical Ingredients (APIs), filing their first patent for an ALD-encased API in 2013. Once seen as impossible, today Nanexa is leading the first clinical study in an ALD-encased pharmaceutical, and the first pharmaceutical manufacturing plant with ALD capabilities is in development.

ALD pharma pioneers

Nanexa has strong roots in industrial innovation through its origins at the Ångström Laboratory at Uppsala University, where it developed Atomic Layer Deposition nanotechnology and semiconductor technology.

Today Nanexa has a small-scale Atomic Layer Deposition manufacturing and fill and finish facility in Uppsala where it produces ALD coatings and fills vials. The facility is GMP-ccertified to produce clinical trial material by the Swedish Medical Products Agency.

Plus, it is is partnering with Applied Materials Inc, global leaders in ADL, to scale up its manufacturing capabilities with a new aseptic, two-line manufacturing plant for PharmaShell which will increase production to up to 3 kg batches, fill and finish is onsite too. The completed pilot plant will be the first GMP pharmaceutical manufacturing plant in the world with full Atomic Layer Deposition capabilities.

ALD pharma pioneers

Nanexa has strong roots in industrial innovation through its origins at the Ångström Laboratory at Uppsala University, where it developed Atomic Layer Deposition nanotechnology and semiconductor technology.

Today Nanexa has a small-scale Atomic Layer Deposition manufacturing and fill and finish facility in Uppsala where it produces ALD coatings and fills vials. The facility is GMP-ccertified to produce clinical trial material by the Swedish Medical Products Agency.

Plus, it is is partnering with Applied Materials Inc, global leaders in ADL, to scale up its manufacturing capabilities with a new aseptic, two-line manufacturing plant for PharmaShell which will increase production to up to 3 kg batches, fill and finish is onsite too. The completed pilot plant will be the first GMP pharmaceutical manufacturing plant in the world with full Atomic Layer Deposition capabilities.