Manufacturing Medicines of the Future

Posted by Dr Qasim Rafiq on 21 August 2017

Britain's greatest invention

The discovery of penicillin in 1928 and the development of antibiotics was recently voted as Britain's greatest invention and is considered by many as the greatest medical advancement in human history. Whilst Sir Alexander Fleming is widely recognised as being the first to discover the antibiotic - receiving a Nobel Prize for his work on the drug - not many people are familiar with his two co-recipients who shared the Prize, Sir Howard Florey and Ernst Chain. Florey and Chain were instrumental in developing a large-scale manufacturing process that enabled penicillin to be mass-produced. This meant that enough of the drug could be produced cost-effectively at quantity and quality suitable for clinical application, making the drug widely accessible to all.

The work of Florey and Chain underpins my approach to modern biological/clinical discoveries where we often seek to address the question of how to take the exciting laboratory discoveries and develop production processes that enable us to manufacture advanced medicines so they are accessible to the global population.

Advanced medicines - cell and gene-based therapies

Since the discovery of penicillin, the continued development of novel, affordable and efficacious therapeutics is necessary to advance global healthcare.

Cell and gene-based have the potential to tackle a broad range of areas, from addressing previously unmet patient needs, to leading the new generation of future medicines set to improve health and wealth across the globe.

These are novel therapies where whole, viable cells (often stem cells) form the basis of the product and are administered to the patient with the aim of facilitating regeneration and targeting acute and chronic conditions.

Personalised medicines - vein to vein manufacture

In addition to addressing unmet clinical needs, cell-gene therapies will also usher in a new era of medicines, that are patient-specific, or personalised therapies. This requires a radically different manufacturing process referred to as 'vein-to-vein manufacture' where the starting cellular material is isolated from the patient, activated and manufactured in a laboratory environment and then transferred back to the patient.

Personalised therapies offer significant clinical opportunity and present numerous manufacturing challenges to ensure the process is not only cost-effective and reproducible, but that individual patient samples are appropriately bio-preserved, segregated and monitored throughout. Such a manufacturing paradigm requires the development of new business and commercialisation models in addition to a significant focus on supply chain and logistics. Our research at UCL Biochemical Engineering recognises the need and value of an integrated and interdisciplinary research approach and we work alongside clinicians, biologists and industry to ensure we consider every aspect of the manufacturing process.

The engineers are coming

As with Florey and Chain, the true potential of cell-gene therapies and personalised medicines will only be realised when engineers are involved and lead the development of scalable, cost-effective manufacturing processes. EPSRC have been instrumental in facilitating translational research for advanced medicines manufacture and have enabled the engineers to take an active role in this field.

I feel I am very much a product of the EPSRC, having graduated from the first cohort of PhD students from the EPSRC and MRC Centre for Doctoral Training (CDT) in Regenerative Medicine at Loughborough University and subsequently awarded an EPSRC-funded E-TERM Landscape Fellowship Award. I have witnessed first-hand how transformational such investment can be and how it can accelerate the career path for early-career researchers going into academia and industry. I completed my PhD in 2013 and gained a collaborative peer-network as part of the CDT and E-TERM programmes which I believe was fundamental in my recent appointment as a Senior Lecturer at UCL. Moreover, many of my colleagues from the CDT and E-TERM programmes have found that investment from the EPSRC in nurturing and supporting early-career researchers has been a key part of their success, and has established them on the path as future leaders in the field.

The UK is considered to be at the forefront of advanced therapy manufacture and I believe much of this is down to the investment in not just infrastructure and facilities, but the renewed investment in people and skills. This is a key asset for an emerging high-value manufacturing industry and will enable the UK to be a global pioneer in a post-Brexit world.

Author

In the following table, contact information relevant to the page. The first column is for visual reference only. Data is in the right column.

Photo of Qasim Rafiq
Name: Dr Qasim Rafiq
Section / Team: Senior Lecturer in Cell and Gene Bioprocessing
Organisation: University College London
Telephone: +44 (0)203 108 4420

Qasim Rafiq is a Senior Lecturer in the Department of Biochemical Engineering at University College London and leads multiple projects involved in the manufacture of advanced cell and gene therapies including InnovateUK projects with Biovault Technical and Sartorius Stedim and an EU-H2020 project, Autostem, which involves the development of an automated manufacturing facility for human stem cell production.

Qasim can be found on Twitter and LinkedIn.

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