Bluepharma's production site in Eiras is special: state-of-the-art facility devoted to contained manufacturing of potent medicines, largely for cancer treatment. At the heart of its expansion drive, guided by common principles of innovation and excellence, the company nurtured the vision of equipping this centre with a production unit for injectable medicines, whose complex composition and process technology guarantee high added value. This new unit was designed to meet the highest regulatory requirements, including as provided by the recently reviewed Annex 1 of the European Union's Principles of Good Manufacturing Practice. Thanks to this unit complex injectable medicines for human use will be manufactured on different scales, i.e. pilots, batches for clinical research, and marketing on a small scale.
Equipped to fill a range of formats (e.g. vials, pre-filled syringes or cartridges), the unit will allocate dedicated areas to the manufacturing of injectable medicines with potent and non-potent active ingredients, duly segregated from the point of view of air treatment, designed to achieve ISO7/B Grade cleanroom classification whenever necessary. The technical areas are designed in such a way that separate operator, material and product flows ensure maximum safety.
The fill&finish operations will use advanced isolator technology capable of decontaminating surfaces using hydrogen peroxide, by combining the principles of sterility and containment. This system makes it possible to operate in less demanding classifications of ISO8/C Grade cleanrooms, while protecting the product and critical processes from the main source of contamination: the operator. The isolator will include a freeze dryer, equipped with an automatic corking and clean and steam-in-place system, which is key to sensitive injectable formulations.
Intended for the formulation of complex products, the unit will have highly customised stainless steel reactors available for easy stirring up to 400 L using magnetic stirrers or advanced mixing, such as emulsions (up to 20 L) and solvent removal (up to 400 L). In parallel, single-use systems, which are currently widely used in aseptic and highly customised processes, will be explored for easy cleaning and mitigating the risk of cross-contamination. All formulation and fill&finish areas will be supported by adjacent operational zones, including a microbiology lab in charge of conducting the microbiological control of environmental samples.
The development and future operationalisation of this new unit will be based on Bluepharma's strong scientific and technological experience: more than 100 scientific papers published, 10 plus patents submitted and/or granted, successful scale-ups of up to 55 L and several formulations undergoing clinical trials. Furthermore, strong in-house analytical capacity, using cutting-edge technologies, such as dynamic light scattering (DLS), high-pressure or ion chromatography systems coupled to different detectors (MS/MS, PDA, PAD) and customised dissolution systems are essential tools for the morphological and chemical characterisation of complex formulations.
Expected to be completed by the first semestre of 2026, the injectable medicine unit represents the materialisation of an ambitious vision of the company. As the product of the commitment and resilience of all teams, from the preliminary designs of the project to the construction phase, this infrastructure symbolises a paradigm shift that will yield new knowledge, new challenges and new opportunities. The project enhances the culture of innovation, team spirit and perseverance that inspire Bluepharma and underpin its strategy for the future.