Article by António Nunes and Marcos Monteiro
The journey from developing products based on low molecular weight molecules to pioneering complex injectable and advanced therapies exemplifies the transformation that pharmaceutical industry must undergo to stay competitive and innovative. Bluepharma stands as a proof of this evolution, showcasing how a persistent focus on innovation and excellence can boost a company to the forefront of the Portuguese Pharmaceutical Industry. For Bluepharma, this has meant investing in research and development, building a robust pipeline of innovative products, and leveraging cutting-edge technologies to enhance its offerings. The company's track record of successful product launches and its state-of-the-art manufacturing facilities are an evidence to its strategic focus on differentiation.
Bluepharma's journey from small molecules to advanced therapies is a story of vision, innovation, and a commitment to making a difference in patients' lives. Today, we are not just a manufacture but an integrated CRDMO, connecting Research, Development and Manufacturing, to bring complex and innovative therapies to market.
As we explore the different sides of Bluepharma's growth, we will delve into the foundation of its success, the innovative projects that set it apart today, and its ambitious vision for the future. This journey is not just about where Bluepharma has been, but where it is going.
The foundation of Bluepharma success - Pipeline and Complex Injectable Technologies
Bluepharma's journey from a manufacturer of conventional generics to developing advanced, high-value therapies showcase its commitment to innovation and differentiation.
Approaches to Innovation and Differentiation
Bluepharma has pursued a differentiation strategy to create value through innovation, growing organically and adopting two complementary approaches:
- Collaboration with scientific institutions to promote endogenization of knowledge and development of innovative medicines. This strategy has resulted in novel technological platforms, valuable intellectual property and strong partnerships that address not only technical limitations but also develop products to meet unmet medical needs while also contribute to access global markets.
- Creation of innovative drug-focused startups in partnership with scientists and investors. Their expertise combined with Bluepharma extensive experience in pharmaceutical development, regulatory affairs, quality assurance, business management, and market knowledge accelerate development, leading to successful companies like Luzitin and TREAT-U S.A, that achieved orphan drug designation status for their lead candidates from the EMA and FDA.
Building a Strong Foundation: Track Record and Expertise on Complex Injectable's
Bluepharma's significant expertise in complex injectable formulations underscores its competitiveness in a field with limited development and manufacturing capabilities worldwide. This expertise is built on over 20 years of experience among Bluepharma's researchers, who have collaborated extensively with centres of knowledge such as universities and research institutes. The Bluepharma strategical involvement and effort have resulted in at least three patent, more than 20 PhD theses, and more than 75 peer-reviewed scientific articles.
Bluepharma has invested in qualified human resources, analytical equipment, and state-of-the-art facilities. These investments have enhanced the company's ability to develop and manufacture complex injectable formulations based on lipid nanoparticles (LNPs) of low molecular weight molecules. Strategic partnerships with multinational companies have facilitated the development of formulations, manufacturing processes, and control methods for different off-patent drugs based on LNPs.
Bluepharma also made substantial investments in developing and implementing complex injectable platforms - BlueCI™ platform - which is central to Bluepharma's differentiation and internationalization strategy. This technology enables the incorporation of various therapeutic agents into complex injectable formulations, providing significant advantages in extending the lifecycle and intellectual property of existing medicines. By presenting these advanced formulations to pharmaceutical companies, Bluepharma explores new market opportunities and reinforces its position in the pharmaceutical industry.
Bluepharma has also an important track record in European projects to bring novel therapeutics based on complex injectables to the market:
- Folsmart project, where Bluepharma contributed with the formulation development, scale-up, GMP manufacturing, quality control, stability studies for a lipid-based methotrexate formulation, which entered clinical trials in 2021.
- Inject4Pain Project, with the development of a complex, long-acting polymeric nanoparticle (PNP) injectable´s platform.
II: Innovative projects - Leveraging Differentiated Services and Capabilities
In the rapidly evolving landscape of medical research, the emergence of mRNA-LNP technology has proven to be a pivotal moment, exemplified by its indispensable contribution to the rapid research, development, and distribution of COVID-19 vaccines. This breakthrough not only stressed the adaptability and efficacy of mRNA-LNP platforms in addressing pressing global health crises but also highlighted their vast therapeutic potential across a spectrum of clinical applications, especially in oncology. Recognizing this potential and supported by its experience, Bluepharma is leading a new project – CInTech - to explore its potential in various diseases, especially cancer.
The CInTech Project: Propelling us to the future
CInTech, short for the Technological Hub for Innovation, Translation and Industrialization of Complex Injectable Drugs, is a project led by Bluepharma and involves the collaboration of several consorts to develop and scale-up lipid and/or polymer nanoparticles for delivering small molecules, nucleic acids or peptides.
This project aims to innovate, translate and industrialize complex injectable drugs by integrating research, scale-up, and GMP manufacturing activities into a single hub. In particular, this hub consists in the establishment of three integrated centres:
- Laboratory-Scale R&I Centre: Dedicated on stimulating the technology transfer interface from national academia and research centres to innovative SMEs and start-ups;
- Development and Scale-up Centre: Focused on analytical development, prototyping, and pilot-scale proof of concept. This centre can develop and scale-up products from the consortium or third parties;
- Specialized GMP Centre: Capable of manufacturing complex injectable drugs developed and scaled-up by the consortium or third parties for clinical or registration purposes.
CInTech's innovative approach brings together novel therapeutic targets, the design and synthesis of new raw materials and therapeutic agents, the development of new lipid- or polymer-based drug delivery platforms, and the creation of new customized equipment and associated digital solutions. Furthermore, CInTech will promote novel CDMO services, ensuring comprehensive support for the entire drug development process.
Strategic vision and future goals
CInTech is a transformative and disruptive project that will result in an innovative and sustainable model of value creation. By promoting knowledge endogenization, developing novel raw materials and high-value pharmaceutical products based on nanotechnology, and designing innovative engineering solutions, Bluepharma, through CInTech, will be able to not only license new technology but also supply products and technological solutions to innovative pharmaceutical and biotechnology companies.
In the post-project phase, Bluepharma anticipates significant growth in business volume through commercial manufacturing of high-value products, depending on regulatory approvals in various territories.
The project's long-term impact on the Portuguese Innovation ecosystem and the global pharmaceutical market will be profound, fostering a highly differentiated portfolio and enhancing Bluepharma's position in the pharmaceutical industry.