Biological medicines – the medicine of the future is already here
What are biological medicines – and why are they being talked about so much? Gene therapy, mRNA vaccines and Advanced Therapy Medicinal Products (ATMP) have become increasingly common in news reports and morning television programs in recent years.
By 2023, biological medicines already accounted for 41 % of the Swedish drug development pipeline – a figure that is expected to increase further by 2027.
Biological medicines, or biologics, is a broad term that covers everything from vaccines, peptides and proteins to growth hormones, immunomodulators, monoclonal antibodies and products derived from human blood and plasma. Unlike traditional synthetic drugs, biologics are usually produced from living cells, bacteria or blood. They can consist of sugars, proteins, nucleotides – or complex combinations of these – and sometimes even whole cells or tissue.
Peptides and proteins have been the most approved biological modality by the FDA during the period 2005–2021. Of the 22 pharmaceutical companies with the highest revenues, 19 had proteins as both their research focus and commercial basis.
Sweden – a hidden force in biological drug development
Sweden may sometimes feel like the ‘land of moderation’, but in Life Science we are anything but shy. With over 159 biotech and pharmaceutical companies, many of which focus on biological drugs, Sweden has a strong position. In fact, we are ranked fifth in Europe in terms of the number of drug candidates in development.
Among the most prominent players are AstraZeneca, Sobi, BioInvent and Alligator Bioscience – as well as a host of innovative small and medium-sized companies. Investments in GMP production have also increased, with facilities at NorthX Biologics and Cytiva focusing on monoclonal antibodies and other advanced modalities. Sweden is thus building capacity from research and development all the way to production.
Biological drugs have the potential to treat a range of different conditions, but they come with their own challenges. They require different analysis methods than traditional small molecule drugs, place special demands on dosage form and influence the choice of route of administration.
Many biological drugs are sensitive to temperature and must be stored cold – often in a refrigerator – which can be impractical for patients who are travelling or on holiday. In addition, studies show that treatment compliance is higher when drugs can be taken in tablet form compared to injections.
A clear example is the mRNA vaccine against COVID-19, which required an unbroken cold chain to maintain its effectiveess. This creates problems in areas with poor infrastructure or when transport breaks down in the summer heat. Therefore, new, innovative formulations and preparation forms are needed.
The NucleoDry project, run by RISE in collaboration with Karolinska Institutet, NorthX Biologics and Vecura, investigated the possibility of freeze-drying mRNA vaccines to increase their shelf life. The results show that efficacy can be maintained – and even improved – by freeze-drying, but that this requires careful selection of ingredients and a new formulation when changing mRNA versions.
The regulatory side is also complex. Biological medicines cannot be tested using the same standard methods as synthetic medicines and require specific parameters to ensure patient safety.
The biological medicines of the future – technology, AI and new opportunities
Globally – and also in Sweden – we are seeing a clear trend: more biological modalities are being developed, and the market is growing rapidly. Forecasts show that biological drugs will soon dominate over traditional small molecule drugs. Almost all of the world's 20 largest pharmaceutical companies currently have an active interest in biological drugs, often with several different therapeutic modalities.
Following the success of the COVID vaccine, mRNA and protein-based vaccines, with or without lipid nanoparticles as carrier systems, are predicted to become an important part of the future pharmaceutical landscape. However, as lipid nanoparticles are sensitive to pH and temperature, the focus is likely to shift towards new carrier systems.
Targeted delivery is an area with great potential – especially in cancer treatment – where the goal is for the drug to reach specific cells or organs, rather than being absorbed locally at the injection site.
Administration methods are also a hot area of research. Today, most biological drugs are administered as injections, but being able to take them as tablets would be a revolution for both healthcare and patients. To achieve this, increased stability and better absorption via the intestine are required. Alternative routes such as nasal sprays or inhalers can also improve the quality of life for patients on lifelong medication.
AI and machine learning already play an important role in the development of biological drugs, for example by predicting protein folding and molecular interactions. In the future, AI will likely be used in ways we cannot yet imagine. The increased focus is clearly evident in calls for proposals from, for example, Vinnova and the Swedish Research Council.
RISE has hundreds of AI researchers and runs MIMER – one of the EU's AI factories – which shows that Sweden has both the expertise and the ambition to be at the forefront.
Sweden's chance to lead – but only if we invest
Biological drugs are not just the future – they are already here. For Sweden to maintain its strong position and not fall behind countries such as India, China and the United States, continued investment in research, innovation and production in this area is required. At RISE, we see biological medicines as a strategically important field of research – and we are ready to take the next step.
