Medilink News Summer 2021 - Page 12

North East boasts significant manufacturing capabilities , says NE Advisory Group Chair
Liverpool School of Tropical Medicine leads on COVID-19 vaccine and human infection research
North East boasts significant manufacturing capabilities , says NE Advisory Group Chair
“ It is easy to overlook how critical the role of the North East is in what has been a global response , and perhaps we need to burn the bushel and shine some light on our brightest stars ” – says Sam Whitehouse , Chair of Medilink North East Advisory Group , speaking about the manufacturing capabilities of the region .
Sam has recently taken over as CEO of High Force Research which supplies chemical compounds to major biotech companies , 80 % of which go to the USA , from its facility in Durham .
The manufacture of the Novavax vaccine for COVID-19 at the GSK facility in County Durham is another example of the North East ’ s impressive manufacturing capabilities , which help save lives and create high value jobs for the regional economy .
FujiFilm Diosynth Biotechnologies produce the protein antigen component of the Novavax vaccine in Stocktonon-Tees , only 30 miles from the GSK ’ s Barnard Castle factory . Novavax ’ s NVX-CoV2373 vaccine candidate has presented strong efficacy in Phase 3 clinical trials , with data showing that it is 96.4 % effective against the original Covid-19 strain and 86.3 % effective against the UK variant .
“ Following the difficulties that the UK experienced at the beginning of the COVID-19 pandemic in securing urgently needed medical supplies and components , it is essential that the UK becomes more self-sufficient and continues to invest in the life sciences ecosystem , particularly in our manufacturing and supply chain resilience .”, says Sam .
Liverpool School of Tropical Medicine leads on COVID-19 vaccine and human infection research
A world-first study carried out at the Liverpool School of Tropical Medicine explores the effectiveness of mixing different COVID-19 vaccines on the immune system . The purpose of the study is to test whether combining doses from different manufacturers may give longerlasting immunity against the virus and any new variants . The vaccine trial started in February with the focus on AstraZeneca and Pfizer , and has recently expanded to include Moderna and Novavax .
The LSTM ’ s work on the innovative therapeutic solutions for COVID is part of its £ 18.6m funding received from UK Research and Innovation ( UKRI )
Strength in Places Fund , which recognised the Liverpool City Region and the world-class expertise in the North West .
Dr Helen Hill , Co-Prinicpal investigator of the study at the LSTM , said : “ What we are trying to do is look at whether or not , if somebody had either AstraZeneca or Pfizer in February this year , and we need to boost them with a different vaccine such as Moderna , or a newer one called Novavax , or the same vaccine again we will look to see what those comparisons are so in future this could be a method they used in the roll out .”
MEMBER INSIGHT EXPERT VIEW Key lessons for those creating and developing vaccines Christiana Demetriou, Associate at Hill Dickinson LLP I am delighted to be contributing to the bi-annual Medilink News on the theme of ‘Manufacturing and Research Excellence: COVID-19’. Vaccines are the “hot topic” for 2021 and, we believe, for the next few years at least. Faced with the uncertainty of what the future holds in relation to Covid-19 vaccines and booster jabs, the UK is enhancing its capability to manufacture and research vaccinations on UK territory. With uncertainty, in relation to Covid-19 spreading and the development of new Covid-19 vaccines and booster jabs, there comes a lot of research and development. Given that in the UK we have some of the best scientists and research developers in the world, it is not surprising that we want to push our own capability to produce vaccines rather than rely solely on international supply. When developing and creating a vaccine, manufacturing and research go hand in hand, especially during the early stages. At Hill Dickinson we have been lucky enough to work with expert leaders in the field of developing and creating vaccines. Some key lessons we have learnt are: • It is important to get the supply chain correct at an early stage, by identifying the equipment and consumables that will be required to produce the vaccine (everything from DNA to the glass bottles used to transport the vaccine for dispensing “fill finish”). Suppliers are often based internationally, so liaising between the EU, the USA and elsewhere whilst trying to align the project timeline can be a challenge in itself. • Commercial agreements with the suppliers must be fit for purpose and fairly drafted, especially when considering delivery arrangements (for example when does title pass?), long lead times (some suppliers may have over 40 weeks lead time to deliver their goods) and warranties on their product (the longer the better). • Manufacturers of the vaccine may also enter into funding agreements with external funders such as government bodies who may request that specific clauses flow down from the funding agreement to the suppliers’ commercial contracts so that the manufacturer has recourse against its supply chain i.e. specific cancellation terms. • A risk with suppliers with long delivery lead times is that contracts may be entered into at risk, as there are limited suppliers for certain products i.e. specific DNA strands. At the same time as negotiating the commercial terms, the quality team will also need to be assessing each supplier from a GMP/regulatory perspective. Any regulatory issues could delay an order being placed with the supplier and cause a delay in the manufacturing timeline. • When a clinical trial does not go to plan and the results are not what was expected, contingency plans and new project timescales must be worked on and drawn up within a matter of weeks to maintain momentum. Aligning manufacturers, suppliers, CMOs, funders etc is just part of the process, when trying to come up with new timelines which everyone can adhere to. Over the last 12 months, we have been fortunate to support and integrate closely with a key client involved in developing and creating one of the Covid-19 vaccines, assisting them with legal advice and day to day project management. Clearly the process and speed of development of Covid-19 vaccines has been unique, but perhaps provide lessons and a template for other vaccine development in future. Based on our experience, there is never a dull moment in doing so! These views expressed are those of the author, and not necessarily Medilink. PRISM MEDICAL LAUNCHES NEW MOBILE APP AND ANNOUNCE EXECUTIVE CHANGES Prism Medical, a Wakefield-based company providing patient moving, handling and bathing products, has launched a new mobile app for occupational therapists and healthcare providers which will enable them access product specifications. The tool will offer high-resolution imagery, ‘how to’ videos and product demonstrations. The OT App puts emphasis on the user experience, and allows clinicians to search by ‘type’, ‘room’ and product tags to help them easily access the information they need. Early feedback on the app indicates its usefulness and convenience, enabling users to find out what they look for quickly. 12 Prism Medical has also announced executive changes, with Paul Morton being appointed as the new Chief Executive Officer, with current CEO, Stuart Meldrum, moving into the Executive Chairman position. Paul Morton, CEO, said: “It is a privilege to be able to lead our colleagues at Prism Healthcare in the next stage of our journey. Our goal is to help healthcare professionals provide the best client care, whilst providing clients and their families’ greater choice and independence. I am passionate about delivering more value for our customers in the UK and abroad, and looking forward to working closely with them.” How can 3D Printing Influence your Medical Device Business? Terence Logan, Sales Manager at Addition Design HAVING TROUBLE OBTAINING SUPPLY OF PARTS? When most people think about 3D printing, they generally think of prototyping or something they watched on TV; Grey’s Anatomy printing a heart valve, for example. But where does the reality lie? Since its inception, 3D printing (Additive Manufacturing or AM for short) has moved along at a steady pace; never racing ahead, but always being referred to as “the latest technology”. More recently and particularly post COVID-19, this technology has gathered pace and now the strides, that have always been hinted at, are becoming more like jumps, as new materials, faster production and larger machines drive the industry forward intoindustrial use of the technology. Disruptions to supply chains are always a risk to businesses, and this was one that was realised in the aftermath of COVID 19’s first wave. The use of AM means that no specific tooling is required and as new engineering materials available begin to match the performance specifications of traditional materials, Addition has seen an increase of change part orders and tooling required within the pharmaceutical sector where OEM (original equipment manufacturer) supply is delayed. Part consolidation and its implications is not something people generally consider when reviewing their parts. But by working with a specialist designer in additive manufacturing, two parts or more can be created as one single part with potential benefits such as increased strength, reduced size and lower production costs when compared to using conventional methods. But what does this mean to a medical device or pharma business and how can these breakthroughs help? The “market of one” is where industrial 3D printing comes into its own. The ability to produce hundreds of unique parts at the same time for different customers offers medical businesses some valuable opportunities. A study by Deloitte highlights that 1 in 5 of consumers would be willing to pay 20% more for a personalised or bespoke product indicating a shift in consumer mentality away from monetary cost, and towards inherent value. Production of completely bespoke products using 3D printing has already disrupted the US hearing aid market where it is now dominated by AM use and we have seen the technology trickle into prosthesis, orthotics and physiotherapy. Reducing time to market of a new product is always something that benefits any business. 3D printing prototypes has been key to reducing deadlines within early design phases in the past decade. Addition Design is an additive manufacturing and 3D printing consultancy unlocking maximum value in the use of industrial 3D printing technology and additive manufacturing. It is not only in the prototyping stage that savings can be made though. Reducing labour costs is a key problem for many manufacturers and there are a few ways that industrial 3D printing can help with this. Images courtesy of Addition Additive Manufacturing The image above shows a capsule counter designed in medical grade PA11 (USP VI). Created for a clean room environment, this device allows the user to quickly count and dispense the correct number of capsules for the container. Although 3D printed, the medical grade polymer is suitable for end-use and because of its shape and form, this product could not be made as one part using conventional manufacturing. By utilising this product, the customer has seen productivity increase by 30%. Creating jigs to ease with production bottlenecks increases morale in potentially laborious tasks, reduces repetitive strain injuries, reduces reject rates and most importantly, saves time and money. 13