PHOENIX consortium is composed of experienced and well-established beneficiaries in their respective fields, which provide PHOENIX-OITB all necessary infrastructures to cover all the aspects of GMP manufacturing of nano-pharmaceuticals from development and technology transfer through scale up to regulatory guidance. PHOENIX-OITB is established as a unified body and operational structure to sustainably coordinate the value chain that will merge all services necessary to develop solutions for end-users. The core PHOENIX-OITB services are designed to meet the expectations of the whole path from initial idea to the market. PHOENIX-OITB makes best use of existing data and expertise by compiling the existing know-how, expertise and technologies within the consortium in “one pot” to be served to the end-users of PHOENIX-OITB.
This service portfolio compiles a list of the services provided by the PHOENIX-OITB. The services range from non-GMP (i.e. R&D and scale-up phase) to GMP (i.e. production phase) environment.
The Portfolio Categories
The PHOENIX-OITB service portfolio is divided into 5 different categories. Each category includes a list of services, all of which together cover the different topics needed for the development of nano-pharmaceuticals from early stage to entry into clinical trials
Surface Properties, Moisture/Dry, Mass, Size & Distribution, Structure, Morphology, Composition, Chemical Stability, Particle concentration, Drug (API) release kinetics, Free/Encapsuled API Sterility
in vitro Characterisation
Composition, Bioactivity, Immunocompatibility, Immunoresponse, Extraction of targeted cells, (A)cellular reactivity & cytotoxicity, Cell viability, Cel. struct., Uptake & localisation, Inflammatory response, Endocytosis/Exocytosis, Sensitization & Irritation, Cytotoxicity, Genotoxicity, Nanomechanical prop. of cells & tissues, Dose metrics, Microbial evaluation, Transcriptomics, Metabolomics, Proteomics, Gene expression
in vivo Characterisation
Biodistribution, Hemocompatibility, Pharmacokinetics, Pharmacodynamics, Acute, Sub-acute & Repeated, Dose systemic toxicity, Reproductivity toxicity
Manufacturing of liquid, semi-solid, solid nanoparticle formulations with a special focus on extended release parenterals, lipid based formulations and nanovesicles, liposomes, solid lipid nanoparticles, crystalline nanoparticles, polymeric nanoparticles, inorganic nanoparticles,. On-site lyophilization and fill and finish capabilities.
Training, Regulatory Support & Guidance, IPR & Business Support, QbD, SbD & SSbD support