Healthcare. Healthcare. The Centre for Process Innovation. From innovation to commercialisation

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1 Healthcare Healthcare The Centre for Process Innovation From innovation to commercialisation

2 The Centre for Process Innovation From innovation to commercialisation The Centre for Process Innovation (CPI) is a UK-based technology innovation centre and a founding partner of the High Value Manufacturing Catapult. We help companies to develop, prove and commercialise the next generation of products and processes. We enable ideas, research and knowledge to be translated into commercial business propositions by providing the facilities and technical expertise to help companies overcome their innovation challenges. Working together, we can help companies to understand the commercial feasibility of their new product or process and get it to market faster and with less risk. Our approach to healthcare innovation brings together multi-disciplinary expertise and experience over a range of emerging and enabling technologies including printable electronics, sensors, photonics, nanotechnologies, formulation science, new materials and biotechnology. We have extensive capability to meet the future demands of the healthcare industry. Working closely with our network of clinical, academic and industrial partners, we help companies translate and validate their products and processes into impactful solutions for both the pharmaceutical and medical technology sectors.

3 The Healthcare Opportunity The global healthcare and life sciences sectors are in the midst of significant change, presenting both opportunities and challenges for the companies operating within them. This change is driven by supply and demand pressures, patient lifestyle choices, longer life expectancies and a rise in chronic disease. The UK s population is predicted to grow from 62.3 million in 2010 to 81.5 million in The demographics of the population will also change significantly. People are living longer, placing increasing pressure on our health and social care systems to deliver a higher standard of care to more patients. By closely integrating universities, the clinical research base, industry and the NHS, there is an opportunity to alleviate these pressures through harnessing new technology, innovation and service models. Emerging technologies such as bio-technology, nano-technologies, novel materials, photonics, big data and the internet of things can be utilised to address these challenges. CPI has extensive experience of working with these collaborative models and emerging technologies, and can provide companies with the facilities and expertise required to commercialise innovative global healthcare solutions.

4 Monitoring and Diagnostics Wearable monitoring technologies Sensor technologies Non-invasive screening Wearable Monitoring Technologies Drawing upon our capabilities in printable electronics, photonics, and systems integration, CPI is working with industrial, academic, and clinical partners to develop novel monitoring devices and systems that measure parameters such as blood pressure, blood oxygen levels, breathing rate and hydration levels to provide an assessment of patient condition. These lightweight technologies can be embedded into everyday items such as clothing, watches, shoes and wristbands, as well as medical dressings and patches, and have the potential to displace the traditional invasive testing methods which require patients to attend hospital appointments. Offering patients the benefits of flexible home use, and medical care providers a low cost means of dramatically reducing the number of patients that must be seen on a daily basis, these devices represent the dawn of a digitally enabled, more efficient healthcare system.

5 Sensor Technologies CPI has expertise in biological and biochemical sensors, which have a wide range of potential applications within the healthcare sector. Biosensors can be utilised in in-vitro diagnostic (IVD) devices to test samples from the human body for infection, and to diagnose medical conditions and monitor drug therapies. The current trend towards point of care diagnostics and personalised home monitoring means there are significant opportunities for IVD technology in the emerging healthcare market. IVD is already used in sexual health, cancer and maternity screening, but the development of new IVD tests is currently an expensive, time consuming, multi-disciplinary activity. CPI can help companies overcome these barriers by facilitating collaboration between partners across the supply chain, and providing world class open access facilities, where our partners can prove that their products are commercially viable before approaching investors or full market deployment. Intellectual property is also an important consideration in the development of these products, and adoption is heavily dependent on gaining access to well established Tier 1 suppliers. CPI can work with companies to connect the supply chain and establish a route to market. Non-Invasive Screening CPI is working on technologies which are leading the way in the development of non-invasive screening methods. Current methods of diagnosis for certain diseases can be uncomfortable and painful for patients. Utilising CPI s capabilities in printed electronics, where the flexible nature of the technology allows for conformable electronics and sensors, future methods of screening can be developed to make the experience much more comfortable for patients.

6 Treatment Biologics Photonic therapies Nanomedicine and drug delivery Biologics Biotechnology is delivering significant advances in healthcare with the production of targeted medicines based on the body s own molecules. As our understanding of human genetics and the molecular causes of diseases continues to evolve, so to does our ability to develop treatments which are more effective and efficient than ever before. Biotechnology has spearheaded the emergence of precision medicines which are developed for specific subsets of individuals based on factors such as their genes, environment, and lifestyle. Precision medicine will be a driving force towards the more efficient, preventative rather than reactive healthcare system that the UK must adopt over the coming years. CPI has world class open access facilities and expertise in the development and manufacture of biologic products and processes. Working closely with our network of clinical, academic and industrial partners, we help companies develop and de-risk new process analytical technologies for the next generation of vaccines, therapeutic proteins, response modifiers, and antibody drug conjugates, without reliance on chemical synthesis. The National Biologics Manufacturing Centre Utilising its National Biologics Manufacturing Centre, CPI helps companies of all sizes to understand the technical feasibility of their new biologic process or technology, helping to get it to market faster and with less risk. CPI focuses on the development and integration of improved process and analytical technologies; formulation, fill and finish, and process development. CPI is fully equipped to help support its partners at every stage of the supply chain.

7 Photonic Therapies As global demand for non invasive, at home treatments increases, the rise of innovative therapies which use light to treat medical conditions is an exciting development within the healthcare sector. Photonic technologies can be harnessed in a range of healthcare applications, including therapies, diagnostics, imaging and surgical interventions. The use of evidence based light therapy is becoming increasingly popular in skin care, ophthalmology and neurology. CPI has expertise in working with companies to develop and commercialise photonic medical devices which treat a targeted range of life threatening diseases. National Centre for Healthcare Photonics In 2018 CPI will open a new national centre to help companies and academia translate their early healthcare photonics research into commercially viable products. Nanomedicine and Drug Delivery Nanoparticle technology is enabling the development of drugs which target the source of disease, offering increased treatment efficiency and minimising side effects. Nanoparticles also present new possibilities for the development of drugs which offer a controlled release of therapeutic substances, stimulating the body s own innate repair mechanisms. This technology can be utilised to develop advanced drug delivery systems to treat a range of diseases, which could potentially enhance patient experience and results. CPI has expertise in this technology and can assist companies with demonstrating and scaling up their own innovative products. This multidisciplinary open access innovation centre will bring together clinicians, medical specialists, engineers, photonics experts, biochemists, health economists and regulatory experts, with a view to accelerate disruptive and radical healthcare innovations that provide benefits to both patients and healthcare providers. The centre will provide the infrastructure required for prototyping, scale-up and validation of devices at the necessary quality and consistency to feed into clinical validation studies. In addition, the centre will offer services that are critical to translating promising technologies into clinical adoption, including access to clinicians, health economics, regulatory planning and clinical trial planning, by forming collaborative partnerships across the healthcare innovation landscape.

8 Manufacture Formulation The future of biopharmaceutical manufacturing Formulation Traditional methods of pharmaceuticals manufacturing are evolving. There is a growing need to reduce production costs, and technology is required to facilitate the industry wide shift towards personalised medicines which demand a flexible production line capable of quickly switching between small lots of a wide range of drugs. There are great opportunities open to those innovators able to develop the novel pharmaceutical solutions to meet these challenges. CPI provides industry and academia with a more cost effective, lower risk route into researching and scaling-up advanced pharmaceutical formulations. We offer world class open access facilities and the technical expertise required to help our partners develop new formulations in areas such as solid dosage, parenteral, inhalation and suspension formulation and encapsulations for release profiling. The Future of Biopharmaceutical Manufacturing The traditional model of large scale batch manufacturing facilities with high capital costs and highly purified services requirements has served the industry well to date, but if a reformed, personalised approach to pharmaceuticals is to be achieved, a radical redesign of processes and facilities will be required. In the future, patient diagnostics will categorise an individual s disease and determine the most effective therapeutic from a range of treatments based on their biological characteristics. Drugs will be manufactured according to demand, using a small-scale, on-site manufacturing unit, that can be rapidly reconfigured for different medicines.

9 What the Future Holds CPI is working towards making small format upstream to downstream production a reality by helping companies to scale down traditional biopharmaceutical manufacturing. The process technologies necessary to manufacture a product could be miniaturised and intensified into self-contained, flexibly-deployed manufacturing units whilst maintaining current clean room standards. Operation of these units would mainly rely on automation, with very little human intervention. One of the key attributes of these future purification processes will be the ability to provide real time measurement and control, to enable the real time release of products. This is perhaps the greatest development challenge to overcome for this vision to become a reality. The ultimate goal is to provide patients with access to effective, precision medicines whenever and wherever required, whilst using sustainable and cost effective methods. CPI is working towards making this concept a reality by helping companies to scale down traditional biopharmaceutical manufacturing methods and develop new techniques for the future delivery of precision medicine. Healthcare Futures Centre CPI is building a Healthcare Futures Centre to enable organisations to explore manufacturing technologies for personalised therapeutic supply chains. Opening in 2019, CPI s Healthcare Futures Centre development and test facility will allow organisations to explore manufacturing technologies that can be directly applied in the new and emerging stratified and personalised therapeutic supply chains. The provision of medicines to patients is undergoing a radical change from one size fits all medicines to a personalised approach. This will have a significant impact on the established medicines supply chain, which is currently configured to deliver large batches of a single therapy to treat multiple patients with the same disease. DNA sequencing technologies are facilitating a more thorough understanding of causative mechanisms of diseases, enabling the differentiation of single diseases into multiple subtypes on the basis of underlying genetic factors. CPI s new centre will accelerate the development of process technologies and facility designs to deliver personalised medicines. It will achieve this through integration and simplification of existing process technologies, to enable production on a much smaller scale, and with rapid change over between products.

10 Healthcare Supply Chain Smart packaging Storage and transportation Smart Packaging Printed electronics enables electronic functionality to be built into cheap and disposable packaging, opening up a range of market opportunities for the pharmaceutical industry and providing benefits for producers, distributors and consumers alike. CPI can help companies create smart packaging solutions for medical products which monitor supply chain traceability and counterfeiting, and prove compliance and authenticity. Printed sensors embedded within packaging have the ability to monitor indicators such as oxygen levels to identify product tampering and whether a drug is fit for consumption. Smart packaging is also easily integrated with near field communication, radio-frequency identification and other wireless based applications to track product progress through the supply chain. This provides manufacturers and distributers with the opportunity to optimise logistics operations and stock control. Storage and Transportation The development of new drug storage and transportation methods is essential if the UK healthcare sector is going to capitalise on the benefits of biopharmaceuticals. The components of many vials and syringes have been found to impact adversely on the stability of some biopharmaceuticals, causing degradation which can render the medicine unsuitable for administration, and in some cases necessitating product recalls. Although this issue is widely recognised within the industry, the causative components and degradation mechanisms have not been fully elucidated. CPI is working with companies to address these issues by determining the root causes of degradation, and designing an efficient screening system to allow early detection of compatibility issues during the development of novel biologics.

11 To find out more about our full range of services visit: call: +44 (0) Industrial Biotechnology and Biorefining Printable Electronics Formulation Biologics Centre for Process Innovation Wilton Centre, Wilton, Redcar, Cleveland, TS10 4RF, United Kingdom T: +44 (0) E: W: Copyright 2016 Centre for Process Innovation Limited. All rights reserved.