A new generation of complex drug molecules—too large to be simple chemicals but too small to be antibodies—is being manufactured using enzymes instead of harsh industrial chemistry. These “new modalities” can attack disease targets that conventional drugs cannot reach, but their intricate structures currently make them prohibitively expensive to produce. The problem is cost. Traditional manufacturing of these molecules relies on multiple chemical steps that generate waste, consume energy, and require expensive solvents. Biocatalysis—using natural enzymes as catalysts—offers a cleaner, cheaper alternative. The University of Manchester, AstraZeneca, and the enzyme company Prozomix have already shown in early experiments that enzymes can assemble these complex molecules with fewer steps and less waste. If the centre succeeds, the cost of producing these next-generation drugs could drop significantly. That would mean pharmaceutical companies could afford to develop treatments for diseases that are currently untreatable, and patients could eventually access those medicines at lower prices. The impact is not on a single drug but on the entire manufacturing pipeline for an emerging class of therapies—making cleaner, cheaper production the new normal rather than the exception.
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In the ever developing world of pharmaceuticals and treatments of diseases new, more challenging drug targets are being identified that require ever more complex drug molecules. These complex molecules or "New Modalities" bridge the gap between the two existing classes of compounds, small molecules (e.g. Aspirin) and biologics (Antibodies), and are typically larger than the existing small molecules but smaller than traditional biologics. These new classes of molecule offer great promise as novel therapies and indeed many of these medicines are aimed at biological targets that cannot be addressed by traditional either small molecule or antibody derived drugs. The complexity of the new modalities currently results in high cost of manufacture which offers an opportunity to develop lower cost routes to produce these compounds. Small molecule manufacturer has benefited from adopting biocatalysis within manufacturing strategies and has demonstrated the potential for use of these catalysts in wider chemical manufacture, such as reduced waste streams, lower energy costs and reduced costs of goods including solvents. Indeed, the project partners have already generated some early proof-of-concept studies, backed up by a wider literature evidence base suggesting that biocatalysis can be used in the synthesis of these new modalities. Through the partnership of the University of Manchester, AstraZeneca and Prozomix we are bringing together a diverse range of experts that will facilitate the development of new manufacturing strategies to produce these new modalities in an efficient and cleaner manner. The use of biocatalysis has the potential to allow access to chemistries and control of manufacture that are otherwise unavailable to the pharmaceutical manufacturing community. Culminating in lower cost manufacturing that translates into greater access to the next generation of drug for a wider community.
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