Leanbio -a Contract Development and Manufacture Organization (CDMO) focused in biopharma industry, based in the Barcelona Science Park- participates in the European project Phoenix to accelerate the development of new drugs based on nanotechnology. This initiative funded by EU’s Horizon2020 Programme with a total budget of €14.45 million for the next 4 years- aims to provide a new infrastructure to facilitate the transfer of nano-pharmaceuticals from the laboratory to clinical practice. A total of 11 partners from academia and industry located all across Europe have joined forces to create this “Open Innovation Test Bed”.

Phoenix project will provide services for the development, characterization, testing, safety assessment, scale-up, good manufacturing practices (GMPs) production and commercialization of nano-pharmaceuticals from the lab to the market, making them available to SMEs, startups and research laboratories.

In addition to Leanbio, the Grace Bio SL company and two CSIC institutes from Spain take part in this initiative: the Institute of Nanoscience and Materials of Aragón (INMA, CSIC-UNIZAR) and the Institute of Materials Science of Barcelona (ICMAB, CSIC). Nanomol Technologies SL, a spin-off from ICMAB-CSIC, is also partner of the project.

The Phoenix consortium -which is led by Luxembourg Institute of Science and Technology, supported by the German SME MyBiotech in scientific coordination- is also integrated by: Cenya Imaging BV (Netherlands) BioNanoNet Forschungsgesellschaft mbH (Austria), Institute for Medical Research and Occupational Health (Croatia), Research Center Pharmaceutical Engineering GmbH (Austria), and Topas Therapeutics GmbH (Germany).

Open Innovation Test Bed for nano-pharmaceuticals

Nano-pharmaceuticals are drugs that use nanotechnology (the use of matter on an atomic, molecular, and supramolecular scale for industrial purposes) in some form to achieve enhanced drug products. Nevertheless, affordable and advanced testing, manufacturing facilities and services for novel nano-pharmaceuticals are main prerequisites for successful implementation of these advances to further enhance the growth and innovation capacity.

The establishment of current GMPs in nano-pharmaceutical production on a large scale is the key step to successfully transferring nano-pharmaceuticals from bench to bedside (from the lab to the patients). Due to the lack of resources to implement GMP manufacturing on site, the upscaling and production of innovative nano-pharmaceuticals is still challenging to the main players of EU nanomedicine market, start-ups and SMEs. To allow a successful implementation of nano-pharmaceuticals in the nanomedicine field, there is an urgent need to establish a science and regulatory-based Open Innovation Test Bed (OITB).

The Phoenix project aims to enable the seamless, timely and cost-friendly transfer of nano-pharmaceuticals from lab bench to clinical trials by providing the necessary advanced, affordable and easily accessible PHOENIX-OITB which will offer a consolidated network of facilities, technologies, services and expertise for all the technology transfer aspects from characterisation, testing, verification up to scale up, GMP compliant manufacturing and regulatory guidance.

PHOENIX-OITB will develop and establish new facilities and upgrade existing ones to make them available to SMEs, starts-up and research laboratories for scale-up, GMP production and testing of nano-pharmaceuticals, either based on small chemical molecules or biologicals The services and expertise provided by the OITB will include production and characterisation under GMP conditions, safety evaluation, regulatory compliance and commercialisation boost.

The role of Leanbio company is to develop and scale-up of nano-pharmaceuticals, of biotherapeutic products and, in conjunction with Grace Bio, the GMPs production to support clinical trials and supply for global markets.

Andreu Soldevila (Photo: Leanbio).

Founded in 2014 by Dr. Andreu Soldevila Fàbrega, Leanbio is a market oriented CDMO that develops and manufactures biopharmaceutical products as new biological entities and biosimilars, applying “Lean bioproduction” through tailored quality by design and ICH compliant approach in order to maximize project success, minimize time to market, costs and risks. The company follows a knowledge-based strategy, applying cutting edge technological platforms and working altogether with customers through the different stages of development across project lifecycle.

Leanbio has invested in facilities at the Barcelona Scientific Park to step into Biotherapeutics with the first biopharmaceutical product in immunotherapy.

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