Medilink News Summer 2021 - Page 10

CPI to develop ‘ library ’ of mRNA vaccines ’ against COVID-19 variants
Liverpool City Region ’ s Seqirus strengthens UK ’ s response to influenza and boosts local job growth

covid-19 VACCINE

CPI to develop ‘ library ’ of mRNA vaccines ’ against COVID-19 variants
CPI , a founding member of the UK High Value Manufacturing Catapult headquartered in the North East of England , has been awarded a £ 5 million investment to support the development of an mRNA ​ ‘ vaccine library ’ as part of the Government ’ s vaccine support package .
CPI has been working with the UK Vaccine Taskforce ( VTF ) since March 2020 , applying its world-leading expertise in the development of mRNA vaccines to support the fight against coronavirus . It is currently the only company based in the UK capable of batch developing mRNA vaccines ready for use in clinical trials and manufacture . When new variants of COVID-19 are identified , their DNA can be used to develop mRNA vaccines in a matter of days .
The vaccines will be banked in a ​ ‘ vaccine library ’, ready for future manufacture and scale-up when needed , with the potential to deliver up to one million doses in a week for use in clinical trials .
CEO Frank Millar said : ​ “ We ’ re delighted to be a key part of the UK ’ s ongoing fight against coronavirus , which has had such a devastating impact over the past year . It ’ s essential that we prepare for a future living with the threat of COVID-19 and the library of vaccine candidates we are building here in Darlington will help future-proof against further outbreaks caused by new strains of the disease . It will mean that as soon as a new strain of COVID-19 is identified , the relevant vaccine can be selected and rapidly manufactured for use in clinical trials , in a very similar way that we see flu vaccines developed each year .”
Liverpool City Region ’ s Seqirus strengthens UK ’ s response to influenza and boosts local job growth
Seqirus , a global influenza vaccine company , has strengthened the UK ’ s vaccine response to influenza with its high-speed syringe filling and packing facility in Liverpool . The facility is the largest vaccine manufacturing site of its kind in the UK , producing over 50 million doses of seasonal influenza vaccine each year , with the ability to increase production to 200 million doses .
The site now has a high-speed fill-and-finish facility , which enables start-tofinish onshore manufacturing , where previously the vaccine would be sent abroad to be put into syringes and packed . This enables Seqirus to complete the entire start-to-end vaccine manufacturing process at the Liverpool site and shortens the supply lead time by more than one to two weeks per batch . The new filling line will also allow Seqirus to produce finished doses of influenza vaccine more quickly in the event of an influenza pandemic .
With its high manufacturing and supply capabilities , the facility will also drive the local economy by creating more jobs .
Nigel Hilton , Head of Manufacturing and Site Head at Liverpool , said : “ Bringing the fill-and-finish capability in house means we can simplify the supply chain , allowing us to shorten lead times to supply vaccines to the UK and other governments who need them .
“ The £ 50m investment also benefits the local Liverpool economy with the introduction of more than 120 high value local jobs at the site , with even more jobs opening up as we expand our supply capability further .”
6
MEMBER INSIGHT EXPERT VIEW COVID LESSONS FOR MEDICAL DEVICE AND MANUFACTURERS AND WHY SAAS EBR IS PART OF THE ANSWER NEIL WETHERALL, MANAGING DIRECTOR, FACTORYTALK UK Those of us who work in medical device manufacturing can be at least grateful that our industry has largely kept going through the pandemic and reinforced how vital our industry is. So, what have we learned about manufacturing during these last few months? More people are working from home and many don’t want to go back to the office. It seems also that employers, who may have been reluctant to allow this before the pandemic, have seen how efficient this can be and how hardworking and committed people have been. The challenge is ensuring we can keep manufacturing our vital products whilst protecting our colleagues. Understanding who needs to be on plant and who could work remotely is key to achieving this. Clearly, people who physically operate plant and equipment will need to be in the production facilities, but who could we enable to work remotely? What about supervisors, managers, QC, QA? There are tools available that can help with remote monitoring and participation in the management of production such as review and approval processes. How can we support remote working in medical DEVICE MANUFACTURING If we look at one aspect of GMP manufacturing, namely production records, it is possible to execute production, review exceptions, approve the batch record and release for sale with most of the people involved working remotely. Tools such as cloud-based Software as a Service (SaaS) electronic batch recording (EBR) systems enable this. Operators will complete the batch record in the system, saving on money, paper and storage. Supervisors and quality assurance staff can log on to the same batch record in real time and see how it is progressing and even respond to exceptions and deviations in real-time. At the end of production, the batch can be reviewed and released for sale remotely with accurate and timely information from the EBR. Future systems and tools Solutions such as SaaS EBR, together with the video conferencing and collaboration tools such as Microsoft Teams or Zoom, will become essential for us to make sure we can keep products being manufactured in these challenging times – and beyond. Perhaps digital manufacturing should be the ‘new normal’ for medical technologies and pharma companies? LEEDS ACADEMICS ADVISE UK GOVERNMENT ON COVID-19 Throughout the pandemic, researchers from the University of Leeds, including Professor Catherine Noakes OBE, have been assisting the Scientific Advisory Group on Emergencies (SAGE) to help ministers make decisions on how to relax lockdowns and combat the virus. Using the principles of fluid dynamics (the analysis of air flows), a team led by SAGE member Professor Noakes, simulate pathogen spread in hospitals and other public buildings and analyse how to reduce threats through more effective ventilation, air-filtration and disinfection systems. The researchers also look at microorganisms on surfaces and have modelled how people touching contaminated surfaces can move microorganisms around the environment and become infected themselves. Professor Giles Davies, Deputy-Dean of the Faculty of Engineering and 10 Physical Sciences at the University of Leeds, said: “The fact that Professor Noakes and others at the University are providing evidence and analysis for SAGE is a tribute to the strength and rigour of Leeds research and innovation. Their contributions demonstrate the University’s commitment and success in playing a leading role in tackling the big challenges facing the world.” Despite the successful vaccination programme, Professor Noakes’ advisory role will continue. “I think there’s now much more of an awareness that the built environment has big implications for how disease transmits, and that’s in all buildings – offices, schools and homes,” she said. Professor Noakes sees an imperative for further research into this link. “We still need to understand how much it matters but this crisis has really brought scientists together to tackle some of these unknowns.” Just How Has COVID-19 Impacted Your Insurance? Mark Philmore ACII, Chartered Insurance Broker, DIRECTOR The impact of the pandemic on the insurance industry has been multifaceted with practical implications in how the sector has functioned, cover disputes and the imposition of new cover endorsements that make very clear the intention of various policies and how they operate. The insurance industry received some very bad press associated with its handling of claims arising from companies being either legally mandated to close or advised to work from home. Some of this was deserved but much of it was contributed to by poor or incorrect reporting in the press that gave many a false hope. The whole business interruption claim issue is complex, however to fully understand the insurance position one needs to appreciate that from its origins business interruption cover is an extension of property damage insurance i.e. covers losses which directly flow from damage to the business’ property. By its very nature, an interruption caused by a disease is not consequent upon damage to property. However, there was some dispute where business interruption policies included ‘non-damage extensions’ and in truth where insurer’s policy wordings were open to interpretation, meaning that they were potentially covering risks that they never intended to. There were a number of issues that were decided in the courts but the key amongst these was that the policy wordings at dispute required a business to have been closed by law as a potential trigger to cover operating, whether in full or part. Most businesses, including life science businesses, were not legally mandated to close but required to ‘work from home where possible.’ Consequently, only a very small proportion of businesses could potentially bring claims if their policies included such cover i.e. those legally required to close such as gyms, cinemas, bars and restaurants. The latest Financial Conduct Authority (FCA) figures suggest that around 37,000 claims have so far been accepted by insurers, totalling around £289m with further claims in the pipeline likely to take this figure up to around £500m. As a consequence, most businesses are likely to have seen very specific and watertight exclusions applied to their policies to remove any ambiguity in relation to business interruption losses due to COVID-19. However, the impact of the pandemic is being felt in other areas of insurance. Most businesses who purchase Directors’ and Officers’ Liability insurance will have seen their premium increase and possibly elements of cover diminished or removed altogether. The D&O market was tough prior to the pandemic due to an increase in general claims activity from amongst other things, greater regulatory scrutiny, claim suits from investors, wider board misstatements, and insurers concerns around board handling of COVID-19 from a trading and operational perspective, which has added to insurers’ general nervousness. Exclusions are being placed on liability focused covers for certain COVID-19 related activities, and should companies be focused on certain COVID-19 related activities they may be subject to further underwriting scrutiny. Finally, whilst all but essential travel abroad has ceased, some insurers are either applying a full COVID-19 exclusion to travel policies, some exclusions have been applied to the Disruption & Cancellation section only or others are relying upon non- overt exclusions deep within the policy wording that exclude disruption/ cancellation as a consequence of any order on the part of a government or ruling body. Whilst most believe that COVID-19 will be with us for some time, it is equally clear that insurers are reacting in way that will see them avoid footing the bill for many of the costs incurred by business resulting from the pandemic. However, given that the current UK Government COVID-19 relief costs outstrip the UK insurance market capitalisation many times over, it is not difficult to appreciate why. The life science sector is complex from an insurance perspective and needs a keen eye to ensure you and your business are best protected. MFL has operated in the sector for approaching 20 years and guided many businesses from start-up to multi-national trading, flotation and beyond. For further information please contact: DDI 0113 323 1042 Mobile 07966 233 287 markp@m-f-l.co.uk www.m-f-l.co.uk MFL Science & Technology is a trading name of MFL Insurance Group Limited which is authorised and regulated by the Financial Conduct Authority. Registered Address Barlow House, Minshull Street, Manchester, M1 3DZ. Registered in England and Wales No. 02817700 11