Author: ITM_admin

An international team of scientists and engineers have been awarded a grant of £768K by UKRI as part of the Newton Fund’s Agile Response Call to develop high performance, low cost ventilators for use in low to middle income countries, it has been announced today.

Prompted by a shortage of ventilators in low income countries highlighted by the COVID-19 pandemic, the HPLV project aims to reengineer a High Energy physics Ventilator (HEV) previously developed by Conseil Européen pour la Recherche Nucléaire (CERN) to create a highly effective, low-cost system that can be easily used in situations where access to reliable power supplies and oxygen may be limited. The system also aims to address the shortage of staff who are trained to operate ventilation devices in these countries, offering a web interface, accessible at local healthcare stations or via a mobile device to open up the potential for remote consulting and clinical training which is crucial for remote areas.

Building upon work by CERN the High Performance Low-cost Ventilator (HPLV) project brings together experts from the Universities of Birmingham, Liverpool and Rio de Janeiro with the Medical Devices Testing and Evaluation Centre (MD-TEC) at University Hospitals Birmingham NHS Foundation Trust (UHB) through Birmingham Health Partners (BHP).

The project team combines expertise in engineering and software development with in-depth experience of ventilator testing and regulatory requirements as well as front-line experience from clinicians in Brazil. The project will also involve business and innovation support from the Science and Technology Facilities Council (STFC) and the knowledge transfer team at CERN who will lead work to engage with potential industrial partners.

Professor Tom Clutton-Brock, Director of MD-TEC at UHB and Deputy Director at the Institute of Translational Medicine said: “MD-TEC is a purpose built medical devices testing and evaluation centre situated in Birmingham, UK. With a fully equipped, but simulated, intensive care unit, it has been heavily involved in many aspects of the UK’s Ventilator Challenge for the management of the sickest patients with COVID-19. With the equipment and expertise required to test ventilators from prototype to production ready, it is a privilege to be part of this exciting project.”

Karl Dearn, Professor of Mechanical Engineering at the University of Birmingham said: “My colleagues and I in mechanical engineering are delighted to work with our international partners at CERN, STFC and our clinical and academic collaborators to develop this innovative low-cost respiratory ventilator.  Based on our Edgbaston campus, our engineering team, so close to our colleagues in MD-TEC,  means that we can be very agile in developing and optimising the ventilator, quickly and at low cost.  There is a shortage of respiratory ventilators across the globe, and this machine has the potential to fill this gap.”

Phil Allport, Professor of Particle Physics at the University and lead at the Birmingham Instrumentation Laboratory for Particle physics and Applications (BILPA) said: “Having been involved in helping CERN as a member of the ‘Support Panel’ for the original HEV ventilator development I also chaired the International Review of the project back in April. The medical experts on the review confirmed this to be a really innovative design, with the functionality needed for ventilators not only addressing the current COVID-19 crisis but offering significant cost savings with respect to equivalent performance commercial systems.

“This funding gives us a great opportunity, with the original HEV team and STFC, to take forward this exciting development from CERN to meet the unmet needs (highlighted by the current pandemic) for ventilators and for training in their operation in many parts of the world where other respiratory diseases requiring ventilators continue to be major killers.”

From hand sanitisers and nasal sprays to improved PPE, the University of Birmingham’s School of Chemical Engineering and Healthcare Technologies Institute (based here in the ITM) have made significant contributions to the global response to the COVID-19 pandemic.

In March, staff set up a manufacturing facility at the Collaborative Teaching Laboratory to produce hand sanitiser, desperately needed at the time by frontline care workers to prevent the spread of COVID-19 due to a national shortage. The facility used chemicals donated from Schools across campus and produced 20 litre batches in accordance with the World Health Organization’s formulation for hand sanitiser. They dispensed the batches into 50ml containers, and packaged them for Birmingham City Council to distribute around the region.

Also amid our response has been a project led by Dr Sophie Cox, Dr David Bassett and Dr Thomas Mills, which saw students and staff from across campus team up to manufacture face visors for frontline medical staff.

The team used their 3D printing expertise to set up a production line at the Collaborative Teaching Laboratory, and used a design taken from a commercially tested blueprint that was supplied by Czech Republic-based PrusaPrinters. The 3D printing technology was used to produce the headband part of the visor, which fits across the user’s forehead, and is attached to a clear plastic visor.

The team produced 2,600 visors to provide additional protection for frontline workers treating people with COVID-19, and donated these to local care homes, hospices and hospitals.

From the outset of the pandemic, it was clear there were issues with wearing facemasks for prolonged periods, such as abrasion and bruising of facial tissues. By early April, Professor Liam Grover and Dr Sophie Cox had started a rapid and intensive collaboration with clinicians and research scientists from King’s College London, to improve the seal and fit of facemasks used by healthcare professionals.

The collaboration brought together expertise in facial imaging, skin interfacing devices and 3D printing, to produce a prototype for a customised mask seal that will improve comfort and reduce exposure risk for people who need to wear facemasks all day, every day.

The researchers worked with University of Birmingham Enterprise to file patent applications, and assign them to a company with an experienced management team and a network of manufacturing partners. MyMaskFit will use the technologies developed at Birmingham and King’s to deliver a service where the care worker scans their face using a smartphone, and within days receives a custom-made, reusable, medical grade facemask within days.

In the early stages of the pandemic, medical staff were faced with rising numbers of critically ill patients, and shortages of PPE. There was the very real concern about transmission during procedures such as intubation or CPR, which put pressure on the chest or forces exhalation of viral-laden aspirate. Dr Richard Williams, Research Fellow at the University of Birmingham’s Healthcare Technologies Institute, and Matthew Campbell-Hill, from the University’s Institute of Clinical Sciences, worked with clinicians and medical experts to come up with a solution. They designed a transparent pop-up tent that can be assembled in 20 seconds to cover the patient’s head and neck area and shield staff, and called their product AerosolShield. AerosolShield can be assembled in 20 seconds, is lightweight and collapsible for easy transport, storage and disposal, and has self-closing access points, allowing easy hand access in and around the patient’s airway, with full line of sight for medical staff.

The team went from design brief, to final design, securing a manufacturing deal and first orders in under a week. Since then AerosolShield devices have been used in GP practices and care homes around the UK, and helped protect an estimated 3,000 staff working in the frontline.

The science suggests that the COVID-19 virus is transmitted in aerosol droplets that not only carry, but also protect, the virus.

A team of researchers headed by Dr Zhenyu Jason Zhang is working on the development of additives that can be included in existing commercial products such as detergents, or integrated within packaging to form an invisible and long-lasting film of sub-micron thickness.

Recent evidence suggests that different surface characteristics such as porosity, rigidity, and roughness all affect the virus’ viability. The team will be drawing on their expertise in soft matter, surface chemistry, formulation engineering, microbiology and the product development capabilities offered by industrial partners to develop new antiviral sprays, films and other products.

The research will take place over the next 18 months in partnership with the University of Cambridge and three key industrial partners: Dupont Teijin Film, Innospec, and FiberLean with the aim of rapidly commercialising the formulations produced.

Researchers led by Professor Liam Grover and Dr Richard Moakes set out to create a formulation for an antiviral nasal spray that can be used as a prophylactic, and also to help prevent person-to-person transmission. Fully aware of the urgency of the situation, they developed a formulation from materials that are already approved by regulatory bodies in the UK, Europe and the US, widely used in medical devices, medicines or food products, and already manufactured to pharmaceutical grade.

They tested a range of compounds for their ability to ‘plume’ when sprayed using a typical nasal spray applicator, and to stay inside the nose after application, before selecting a gellan polysaccharide as the carrier for an antiviral agent, called λcarrageenan.

The researchers then tested the mixture at various different proportions for its antiviral affect in cell culture, and found it could deliver significant suppression of infection compared to untreated controls. This effect was seen up to 48 hours after application, and when the formulation was diluted many times.

University of Birmingham Enterprise filed a patent application for the formulation and is now seeking to license the patent to an organisation that is committed to manufacturing a consumer product and managing its distribution it to the widest possible audience.

A company working with experts from the University of Birmingham and King’s College London has been awarded funding by Innovate UK to produce custom-fitted, reusable, medical grade facemasks that will fit all people regardless of age, sex or ethnicity.

MyMaskFit will focus on producing masks at FFP3 standard, which filter 99% of aerosols.  The FFP3 standard is recommended in healthcare settings where there is a risk of COVID-19 transmission.

The masks will be the first fully custom-fitted, reusable, filtering face piece (FFP) masks made to this standard in the UK.

The issue of mask fit is critically important in healthcare settings, where an adequate seal is required between the mask and the face.  Yet the wide variations in mask design and the inevitable variation in the shape of human faces mean that this fit can be difficult to achieve, and when healthcare staff find a mask that fits, it may not be available at the next round of supply.

Scientists from the University of Birmingham and King’s College London recognised these issues at the outset of the UK lockdown, and started a collaboration that brought together expertise in facial imaging, skin interfacing devices and 3D printing.

Starting in April, this intensive project involved Professor Liam Grover, Director of the Healthcare Technologies Institute based at the ITM, Dr Sophie Cox, Senior Lecturer in Healthcare Technologies, University of Birmingham, and Professor Owen Addison, Chair of Oral Rehabilitation, and Dr Trevor Coward, Reader in Maxillofacial & Craniofacial Rehabilitation, at King’s College London.

Supported by the EPSRC as part of the UKRI COVID-19 response, the combined team rapidly produced a promising prototype for a customised mask seal to reduce exposure risk and fitting time, while also improving comfort for professionals who need to wear FFP masks all day, every day.  Both universities filed patent applications during the course of the project, and the rights to these patents are being licensed to MyMaskFit.

MyMaskFit will now take the product through regulatory approval and bring it to market to meet the growing demand for FFP3 masks.  The first masks will be manufactured in Swansea, Wales.

Paul Perera of MyMaskFit, who conceptualised the project, commented:  “MyMaskFit is bringing clinical knowledge, chemistry and manufacturing engineering expertise.  The company is working with technology partners in the spirit of the UK’s Ventilator Challenge to accelerate the pace of innovation and development so we can supply the NHS and care homes with masks that fit their workers, who will be able to use a mobile device to scan their face, and receive a mask within 24 hours.”

MyMaskFit plans to make technology behind the mask available to developing countries.  It will be assisted in this by the Emergent Alliance, a not-for profit collaboration consisting of large corporates, individuals, NGOs and Governments that aims to build economic resilience in the post-COVID world.

Dr James Wilkie, CEO University of Birmingham Enterprise, which filed the Birmingham patents, said: “This is a fantastic example of bringing university research ideas to market quickly so they can improve people’s lives as soon as possible.”

Professor Owen Addison said: “Both UKRI’s rapid support of COVID-19 responsive projects and outstanding collegial working environment between universities, industry and policy makers during this difficult time is enabling the early translation of this work which can deliver real benefit to the point of greatest need.”

A nasal spray that can provide effective protection against the COVID-19 virus has been developed by researchers at the University of Birmingham based here in the ITM, using materials already cleared for use in humans.

A team in the ITM’s Healthcare Technologies Institute formulated the spray using compounds already widely approved by regulatory bodies in the UK, Europe and the US. The materials are already widely used in medical devices, medicines and even food products.

This means that the normal complex procedures to take a new product to market are greatly simplified, so the spray could be commercially available very quickly.

A pre-print (not yet peer-reviewed) study describes cell culture experiments designed to test the ability of the solution to inhibit infection. They found cell-virus cultures inhibited  the infection up to 48 hours after being treated with the solution and when diluted many times.

The spray is composed of two polysaccharide polymers. The first, an antiviral agent called carrageenan, is commonly used in foods as a thickening agent, while the second a solution  called gellan, was selected for its ability to stick to cells inside the nose.

The gellan, is an important component because it has the ability to be sprayed into fine droplets inside the nasal cavity, where it can cover the surface evenly, and stay at the delivery site, rather than sliding downwards and out of the nose.

Lead author on the paper, Dr Richard Moakes, said: “This spray is made from readily available products that are already being used in food products and medicines and we purposely built these conditions into our design process. It means that, with the right partners, we could start mass production within  weeks.”

The spray works in two primary ways. Firstly, it catches and coats the virus inside the nose, from where it can be eliminated via the usual routes – either nose-blowing or swallowing. Secondly, because the virus is encapsulated in the spray’s viscous coating, it is prevented from being uptaken by the body. That means it will reduce the viral load in the body, but also even if virus particles are passed on to another person via a sneeze or cough, that person is less likely to be infected by active virus particles.

Co-author Professor Liam Grover, says: “Although our noses filter 1000s of litres of air each day, there is not much protection from infection, and most airborne viruses are transmitted via the nasal passage. The spray we have formulated delivers that protection but can also prevent the virus being passed from person to person.”

The team believe the spray could be particularly useful in areas where crowding is less avoidable, such as aeroplanes or classrooms. Regular application of the spray could significantly reduce disease transmission.

“Products like these don’t replace existing measures such as mask wearing and handwashing, which will continue to be vital to preventing the spread of the virus,” adds Dr Moakes. “What this spray will do, however, is add a second layer of protection to prevent and slow virus transmission.”

A new spray for treating severely painful blisters, mouth ulceration and oral scarring in patients with a rare genetic skin condition is being developed by researchers in the Healthcare Technologies Institute, based here in the ITM.

The spray is designed for patients with Epidermolysis Bullosa (EB), a condition that causes the skin to blister and tear at the slightest touch.

Around 5,000 people in the UK are currently living with EB, which is usually diagnosed in early childhood. Symptoms include open wounds and sores where fragile skin is damaged and severe scarring where wounds heal.

EB can be particularly painful when internal linings such as inside the mouth are damaged, making eating and teeth brushing extremely difficult. Scarring inside the mouth can also affect the development of muscles and other tissue.

Researchers in the Healthcare Technologies Institute and the University of Birmingham’s Institute of Inflammation and Ageing are working alongside experts in dermatology and dentistry to formulate an oral spray designed to alleviate some of these symptoms.

Over the next two years, the team will work closely with clinicians and patient groups to design the spray so that it can be delivered directly into the cheek cavity. It will contain anti-fibrotic molecules to both treat the blisters and prevent them from scarring.

The work has been funded by DEBRA, the UK charity dedicated to finding a cure for Epidermolysis Bullosa and supporting the EB community.

Caroline Collins, Director of Research at DEBRA says: “The development of this spray could be a giant step forward in helping to alleviate the constant pain and discomfort EB sufferers experience on a daily basis. The combination of delivery and use of treatments that reduce fibrosis could mean an EB patient is able to properly eat for the first time and maintain basic dental hygiene which many of us take for granted. I am hugely grateful to the team in Birmingham for making this happen.”

Professor Liam Grover, Director of the Healthcare Technologies Institute, is leading the project. “The hydrogels that we are designing have distinctive properties that enable them to stick to the moist tissues inside the mouth,” he explains. “Our aim is to use this formulation to deliver other ‘ingredients’ that can help treat EB symptoms.”

Adrian Heagerty, Honorary Professor of Dermatology at the University of Birmingham, said: “We regularly see EB patients who are unable to eat properly because of pain and discomfort in their mouths, Even brushing their teeth can be painful and damaging, leading to extremely poor dental health. Developing an oral spray that will help patients to eat and maintain oral hygiene could be a game changer.”

As one EB patient explains: “EB will always be part of my life, but this type of treatment could make it less painful to live with. It will be particularly important for younger people, who will be able to use it to help them reduce the damage to the insides of their mouths, brush their teeth more regularly, and keep their teeth stronger for longer.”

Three formulations will be designed, each delivering a distinct anti-fibrotic molecule. The aim will be to test each of these in a comparative clinical trial once the initial research programme has been completed.

Anthony Metcalfe, Professor of Wound Healing at the University, adds: “There is no cure, yet, for EB and so our primary focus is on managing the pain and other symptoms. We’re very grateful to DEBRA for funding this important research.”

By the end of the two-year programme, the team aim to have formulated the spray, and prepared the groundwork for an early stage clinical trial.