The high R&D costs involved in discovering new medicines and progressing drugs through clinical trials are well-reported, but the challenges and rewards in pharmaceutical manufacturing attract much less attention. Yet competitive manufacturing and exporting is ultimately where money is made and the very significant pharmaceutical manufacturing sector in the North is an engine for growth in this specialist area of advanced manufacturing.
The sector’s strategic importance to the UK economy is recognised by the Government with the Life Science Sector Deal announced in December and £162 million of funding focused on medicines manufacturing from the first wave of the Industrial Strategy Challenge Fund (ISCF).
The Bionow Pharma Manufacturing Conference, sponsored by Allergan, Seqirus, Elanco and AstraZeneca was convened on 23 May in Speke, Liverpool, home to likely the biggest biopharmaceutical manufacturing hub in Europe, with 125 delegates in attendance. The aim of the conference was to explore the challenges and enablers for bio-pharma manufacturing in the North and to start a conversation through which the northern manufacturing sites can work collaboratively in areas of common interest - for example, a shared approach to skills and training - and also begin to address the challenge of manufacturing next generation therapies that offer a preventative or curative effect as opposed to treatment.
Peter Timmins, Chair of the Health & Life Sciences Board for the Liverpool City Region, opened the conference and was followed by Laura O’Brien, Site Director at Seqirus, Liverpool giving a keynote address. She highlighted the skills challenge that the sector faces: “Production volumes are growing and the industry is automating for consistency so it needs to upskill manufacturing operators away from manual tasks and towards managing the process and monitoring performance and trends.” Increasingly, entry-level roles in laboratories and production are being filled by graduates. However, despite a high investment in education many lack the practical skills and insights needed to thrive in highly-regulated pharmaceutical manufacturing, so it is a steep learning curve to build experience onto their base knowledge.
At the other end of the spectrum experienced workers and crucially many highly skilled technical staff are approaching retirement. While new technologies, robotics and automation are becoming increasingly deployed, they are dependent on having a ow of motivated graduate scientists and engineers and also skilled process technicians with the skills to adapt to an ever-changing manufacturing environment. The skills workshops, a key element of the conference, examined the issues and perceptions from the viewpoints of school pupils, apprentices, graduates and postgraduates, identifying several areas that need to be tackled, if we are to attract and retain entry-level recruits and unlock their potential.
Precision Medicine is an emerging approach for disease treatment and prevention that takes into account individual variability in genes, environment, and lifestyle for each person. This approach allows doctors and researchers to predict more accurately which treatment and prevention strategies for a particular disease will work best in specific groups of people and can improve outcomes for patients and reduce unwanted side effects. Tailoring medicines for individual patient needs takes this approach a step further. Manufacturing new therapies tailored to the needs of each individual patient would massively improve patient out-comes, reducing healthcare costs while increasing healthcare value.
The next generation technologies of cell and gene therapy are increasingly in the news and represent an area of personalised medicine that is growing quickly – with a global market estimated at $11.5bn and expected to reach $18bn by 2025. Although still relatively small compared with a global drugs market of $1000bn, next generation therapies are game-changing in that they offer the potential to cure life-threatening conditions with a single dose, rather than simply treating the symptoms of a disease or limiting its progression. However, their manufacture brings a whole new set of novel challenges in terms of much smaller batches of highly potent therapies made under sterile conditions, single use/disposable equipment, complex analytics for quality assurance and therefore a high cost-per-dose.
That said, there is much that can be learned from other advanced manufacturing industries. In addition, the difficulties in manufacture create a barrier to entry thus enhancing competitive advantage for those who get involved early. The conference examined the new analytical challenges and the demands of sterile manufacture, crucial for the manufacture of new therapies. It also explored the routes to manufacturing process innovation and some of the practical technical manufacturing challenges for new therapies which will need to be overcome if we are to develop new, cost effective manufacturing processes to provide a competitive manufacturing route to market for innovative therapies, so that value can be retained in the UK.
The pharmaceutical sector is highly regulated and new therapies introduce a raft of novel regulatory challenges. Advanced therapies demand a move away from big batches being manufactured in ‘fixed’ plant which is remote from the patient, towards much smaller batches made in flexible plant much closer to the patient, often a single product for a single patient, the epitome of ‘personalised medicine’. How will we regulate and authorise many smaller manufacturing sites and does this present an opportunity to be proactive in our regulatory approach? Can the UK’s Regulatory framework help to facilitate innovation and shorten the time to market while ensuring the development of safe and productive processes?
David Churchward, a GMP Inspector with the MHRA commented: “The Medicines and Healthcare products Regulatory Agency (MHRA) is both the inspection and licensing authority in the UK, with responsibility for blood components and medicines. MHRA works closely with the UK Human Tissues Authority and is uniquely positioned to convene the best experts to provide specific advice at an early stage. The MHRA is also well connected internationally and can have influence on international standards.”
The conference succeeded in its aim to catalyse the connection of Northern Pharma manufacturing expertise and will meet again in 2019 to take this agenda forward.
For more information see www.bionow.co.uk
This article appeared in FutureNorth's 'Life Sciences Edition' in The Times, 26 June 2018. See more online here and download a PDF here.
Speke Biomanufacturing Cluster
The Speke Biomanufacturing Cluster employs over 1,830 people across the four major sites of:
ALLERGAN BIOLOGICS: The UK R&D Centre of Excellence for Biologics of Allergan plc, a global pharmaceutical company producing treatments for debilitating diseases in eye care, gastroenterology, aesthetics and dermatology and CNS.
ASTRAZENECA LIVERPOOL: A major biologics site handling all aspects of vaccine strain development and manufacture, producing Drug Substance to support the manufacture of 20 million quadrivalent influenza vaccine doses per year for the global market including supplying the nasal spray influenza vaccine Fluenz as an important part of the Government’s extended childhood u vaccination programme. The site employs approximately 350 employees with more than 4000 in total in the Northwest region.
ELANCO LIVERPOOL: Manufactures products by bulk fermentation of bacterial organisms which are used to prevent and treat disease among farm animals. The site was once the biggest maker of penicillin in the world, after it was built to produce the drug for the army and civilians during the Second World War.
SEQIRUS LIVERPOOL: A Centre of Excellence for advanced in uenza vaccine manufacturing. It is one of the biggest biotechnology sites in Europe and the only injectable in uenza vaccine manufacturer in the UK.
Other significant manufacturing sites in the North include AstraZeneca Macclesfield which manufactures Zoladex, an injectable treatment for patients with prostate cancer, GSK (Ulverston and Barnard Castle), BMS, TEVA, Sano Aventis and CobraBio at Keele. Ipsen and Wockhardt manufacture in North Wales, and the North East Pharma cluster is home to Fujifim Diosynth, Sterling, Aesica, MSD, Piramal and Wasdell.