BioNanoNet members and partners found PHOENIX OITB gGmbH to support innovation in nano-pharmaceutical development

A new company has been founded to provide much-needed support to industry, SMEs, startups and researchers developing nano-pharmaceuticals. PHOENIX OITB gGmbH, founded in November 2023, offers an “all-in-one” single-entry-point to users, providing characterization, in vitro and in vivo testing, up-scaling, manufacturing, and consulting services including innovation-related aspects, like regulatory guidance and business to accelerate maturity of nano-pharmaceuticals and diagnostic agents. Along with BNN, BioNanoNet Association members MyBiotech (MyB), Research Center Pharmaceutical Engineering GmbH (RCPE), Nanomol Technologies (NT) and Luxembourg Institute of Science and Technology (LIST) are among the founding partners of the PHOENIX OITB gGmbH, the single-entry-point of the Phoenix Open Innovation Test Bed (OITB). LeanBio S.L. and the Higher Council for Scientific Research (CSIC), both from Spain, are slated to join as founders in the new year. BioNanoNet Association members Institute for Medical Research and Occupational Health (IMI) and RECENDT will offer services within the single-entry-point. The company is headquartered in Überherrn, Germany.

With a strong vision to remove barriers to nano-pharmaceutical innovation, PHOENIX offers affordable and easy access to a consolidated network of facilities, technologies, services and expertise from across Europe for all the technology transfer aspects from characterization, in vitro and in vivo testing, validation up to scale-up, GMP compliant manufacturing and regulatory guidance.

Customers contacting the PHOENIX single-entry-point will be matched with a dedicated contact person to evaluate their needs. The customer will then be matched with relevant experts providing the desired services and obtain a  comprehensive plan of services. The PHOENIX network covers the entire supply chain from bench to bedside, as well as broad range of administration routes.

Available services are categorised within physico-chemical characterisation, in vitro characterisation, in vivo characterisation, GMP manufacturing and innovation. The broad network covers the whole value chain with complementary/synergistic expertise from R&D till GMP. The short decision-making process and high degree of flexibility together with the top-tier expertise and experience give the single-entry-point power and dynamism increasing its value on the market. PHOENIX single-entry-point portfolio is continuously updated based on customer and market needs. A full description of comprehensive services will be located on the website of the single-entry-point, launching in 2024.

To launch the PHOENIX Single-Entry-Point, MyB and BNN developed the business concept and overall sustainability during the first year of the EU-funded project PHOENIX. BNN also leads the communication activities for the project and the single-entry-point, and establishes connections with all relevant stakeholders. During the project lifetime NT and MyB establish the quality management system of the single-entry-point to ensure standardised and high-quality services to its end users.

For PHOENIX customers, BNN offers services in Safe-and-Sustainable-by-Design and Regulation, advising end users how to choose materials and processes that will have the least harm on humans and the environment, and how to succeed in regulatory affairs and reach clinics and the market.

MyB offers GMP production of nano-pharmaceuticals, and all related services including technology and method transfer, scale-up and GMP compliance. NT offers GMP compliant particle characterization and all around nano-pharmaceuticals formulation development. Synergetic ally, MyB and NT responds to the need of obtaining high quality and quantity nano-pharmaceuticals by offering their end formulation and scale-up expertise, as well as key enabling technologies adaptable to customer needs to achieve industrial-scale production.

RCPE has developed a multiscale simulation framework for nanoparticle production processes. This framework is utilised as a digital simulation tool for process design, scale-up or optimisation.

LIST provides services and expertise for the in vitro safety of nano-drugs for a broad range of nano-pharmaceuticals and administration routes.

IMI together with BNN establish and run the Regulatory Support Department, which will offer regulatory support to end-users to eliminate “non-necessary” testing as well as to ensure “certainty” about regulatory compliance of nano-pharmaceuticals under development. The regulatory team will analyse the guidelines and legislation to help the customer in determining any additional testing needed, studies or documents that might be required prior to initiating clinical trials (including briefing meetings preparation and/or preparation of documentation and meetings for the scientific advice, orphan drug designation, etc.).

RECENDT focuses on the application of process-analytical technologies (PAT), providing the development and application of novel and customized solutions for PAT in nano-pharmaceutical production.

The PHOENIX-OITB gGmbH originates from the business development plan of the PHOENIX project funded in 2021 by the European Union under the Industrial Leadership Programme (GA 953110).

Browse the PHOENIX SEP website at https://phoenix-sep.com/.

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Contact

Dr. Nazende Günday-Türeli, CEO
PHOENIX-OITB SEP
n.guenday-tuereli@phoenix-sep.com