The UK's Midatech Group has opened what it describes as "the world's first cGMP-grade manufacturing plant for the production of nanoparticles at a scale commensurate with pharmaceutical applications".
The facility in Bilbao, Spain will initially focus on the design and manufacture of nanoparticles for Midatech's research programmes exploring the therapeutic and diagnostic potential of nanotechnology.
These include using nanoparticles as scaffolds for synthetic vaccines and antibiotics, as delivery vehicles for RNA interference compounds and drugs that can cross the blood-brain barrier, in targeted cancer treatments and as non-invasive imaging agents.
Further down the line, the facility may serve as a production base for nanoparticle alliances. In addition to its in-house programmes, Midatech says, the group is prepared to license its intellectual property covering the design, manufacture and use of nanoparticles in therapeutic and diagnostic applications to third-party development partners. In that case, Midatech adds, it would retain manufacturing rights.
Located on the Zamudio Science Park in Bilbao, the new plant is incorporated as Midatech Biogune S.L., one of three wholly owned subsidiaries operating under the Oxford, UK-based Midatech Ltd.
Also based in Spain, but in Seville not Bilbao, is Midatech Andalucia S.L., which is responsible for exploiting the group's intellectual property relating to magnetic noble metal nanoparticles and their interaction with external alternating magnetic fields. The subsidiary is developing a hysteresis heating device for localised destruction of bacteria and cancerous cells.
The third subsidiary is Cura Vaccines Ltd, based like Midatech Ltd in Abingdon, Oxfordshire and responsible for the commercialisation and exploitation of Midatech Ltd's vaccines platform.
No further details on the manufacturing facility were available at the time of going to press, although Midatech said it was a "key part" of the group's business strategy.
Midatech was set up in 2000 to exploit a process for synthesising self-assembled nanoparticles that was originally developed at the Consejo Superior de Investigaciones Cientificas (CSIC) in Seville. The UK group has obtained exclusive worldwide rights to this technology from the Spanish Research Council.
According to Midatech, its biocompatible nanocells possess a number of unique properties that make them ideal for therapeutic, diagnostic and other enabling applications, such as coatings for devices including microchips.
Among the properties lending themselves to drug delivery, the Midatech nanocells are water soluble and can be designed to either diffuse freely in vivo or to target specific cells, the group says. One class of the nanocells has been shown to cross the blood-brain barrier, offering potential as delivery vehicles for drugs to treat Parkinson's, Alzheimer's and other central nervous system (CNS) diseases.
Moreover, with a diameter of less than 5nm, the unbound nanoparticles are freely excreted from the kidneys, reducing the likelihood of non-specific in vivo accumulation, Midatech points out. Their size also permits drug delivery via different routes of administration, such as parenteral or intranasal, while the nanoparticles' stability to enzymatic digestion may also open a pathway for oral therapy.
Another benefit is that multiple ligands can be attached to a single nanoparticle, raising the possibility of multivalent drug delivery or receptor binding, as well as heterogeneous ligand delivery. Moreover, the outer shell or corona of the nanoparticle can be made invisible to the host immune system, suggesting that the resulting 'stealth' therapies are unlikely to encounter immunological problems, Midatech believes.
From a manufacturing viewpoint, the nanoparticles self-assemble in a single-step chemical process, making for "simple, safe, scaleable and low-cost" production, the group notes.
The furthest advanced of Midatech's product candidates is a tetanus toxoid vaccine, MLT 101, which is at the preclinical proof-of-concept stage in vivo. A vaccine for solid tumours, MTL 102, is at roughly the same stage while two other vaccines - MLT 103 and MLT 104 for avian influenza and prostate cancer respectively - are undergoing in vitro proof-of-concept testing.