A UK Centre of Excellence in in-silico Regulatory Science and Innovation (UK CEiRSI) will scale up activities of the InSilicoUK Pro-Innovation Regulations Network, in pioneering advanced computational modelling and simulation methods (CM&S), aka in-silico methods, to develop and regulate Life and Health Sciences products. Traditional testing for medical and veterinary products is exhaustive and costly to meet stringent safety regulations for both human and animal applications. This usually entails progression from bench testing or cell cultures to animal testing, and human clinical trials. In contrast, sectors like aircraft engineering derive substantial safety and efficacy data from sophisticated computer simulations. Translating this in-silico paradigm to healthcare could revolutionise medical product development by accelerating timelines, curbing expenses, and reducing reliance on animal and human testing. In-silico testing harnesses computational models to simulate the behaviour and efficacy of life/health sciences products throughout their lifecycle. This approach employs digital twins---virtual replicas of medical products, biological systems, or manufacturing processes---and virtual patients (populations) for in-silico testing/trials. These models enable researchers to predict optimal designs and clinical outcomes, enhancing product safety and effectiveness. Digital twins in life/health sciences represent complex simulations of individual patient anatomy and physiology, allowing for personalised medicine and treatment optimisation. Virtual animals, patients, and populations are simulated constructs used in in-silico trials to evaluate the performance of medical interventions without the constraints of traditional clinical trials, offering insights into efficacy and safety across diverse patient groups. Established in March 2022, InSilicoUK (www.insilicouk.org) is a community of over 2,000 stakeholders from academia, industry, and regulatory bodies. The network is dedicated to integrating in-silico evidence into regulatory science, thus improving patient safety, and speeding up the development of medical products. By advocating for computational modelling and simulation, we will advance public health, enhance the healthcare system, stimulate the life/health sciences sector growth, and contribute to the UK's economic prosperity. The UK is set to lead the global shift towards in-silico science and its regulatory acceptance. UK CEiRSI seeks to cultivate a community that supports innovative regulation and establishes a national framework for widely adopting in-silico methods, reinforcing the UK's global influence in life/health sciences. Adopting in-silico testing places the UK at the vanguard of medical product evaluation, solidifying its status as a beacon in life and health sciences innovation. This forward-thinking approach is set to overhaul the evaluation of medical products by streamlining processes, cutting costs, enhancing precision, and upholding patient safety.

The UK Science and Technology Framework, describes the value to be gained through the development and delivery of a pro-innovation, agile system of standards and regulations to facilitate widespread commercial science and technology applications across UK research, development and high tech manufacturing. This project seeks to support those objectives and establish a network able to define and support future standards for digitalisation of regulatory data required for automated manufacture, product review and quality assured release of medicines. The outcomes proposed will benefit industry, the economy, healthcare and patients by increasing productivity, driving efficiencies and reducing waste and costs. Setting new standards and regulatory frameworks will support a reduces risk and the reliance on human workflows and decision-steps, which create potential for error. Automated data analysis and calculation is key to reduce failures in quality review and release, but this will require industry collaboration to deliver the right regulatory endorsed standards and guidelines to reduce entry-risk for those adopting and implementing digitalisation approaches. New medicine development is enabled through digitalisation and new standards complement the development/adoption of new medicines improving healthcare outcomes for all. Developing the consortia to drive the outcomes described and realise manufacturing industry and patient benefits across the UK is the key outcome of the proposal with reduced barriers to entry for digitalisation adoptions helping to pave the way to digitalisation achieved though a collaborative industry needs centred approach including: 1. Wide industry consultation over GMP and regulatory data standards 2. Regulator collaboration to provide guidance's to support and realise the benefits of automated review over current traditional manual-human expert review. 3. Agreed approaches to standardisation and regulation of industry sponsored data sharing across bespoke architectures and diverse datasets.

As the global population continues to grow apace (by a further 25% to 2050), the demand for food will increase. Traditional, agriculture will struggle to fulfil the demands made upon it. Pressure will come not only from the number of people needing to be fed but from other related issues, such as land use change to accommodate more agriculture, increased water use, chemical use, increased eutrophication of water courses, loss of biodiversity and damage to precious topsoils. To address this, several approaches which look to change the course of both food (and feed) production and consumer purchasing habits are being explored. One such approach is to use microbial cell factories to produce nutrient-dense, high quality food/feed ingredients. Microbial food products have the potential to help transform the global food industry away from resource inefficient production, which pollutes and denudes the environment, towards production of highly nutritious food in scalable, fully controlled, contained and monitored, fermentation processes. This project will seek to both improve the process efficiency and sustainability of microbial food production and expand the market opportunity by developing new product streams. The project will develop novel processes for the production of microbial biomass from sustainable feedstocks. Microbial SCP is naturally high in protein and to increase its value as a food ingredient, processes will be developed to generate a soluble protein isolate fraction for use as a food ingredient, with the insoluble fraction for use as an animal feed ingredient. The soluble protein fraction will be assessed for valuable properties such as gelling, foaming and binding, for replacement of animal-derived proteins in meat-free products. The insoluble fraction will be assessed as an animal feed ingredient for farmed fish and piglets. The outcomes of this project will be the development of new processes and technologies to produce novel, nutrient rich, microbially-derived food and animal feed products. The processes developed will be resource efficient, reducing CO2 emissions, with low water and land usage requirements compared to traditional agriculture. The processes will be highly scalable and non-seasonal, using technology that can be deployed anywhere.

The AtlasBio (Ref. 102610) was conceived in response to the government's Innovate UK funding competition "Analytical Technologies for Biopharmaceuticals". The project aims to develop a multiplexed suite of process analytical technologies (based on Raman, near infrared and impedance spectroscopy) which support the freeze drying of biologics from the scale-up of batch freeze-drying to the development and implementation of new continuous freeze-drying methods. Our partners are GEA Process Engineering (LEAD), The Centre for Process Engineering, the National Institute for Biological Standards and Control, IS Instruments Ltd, Blue Frog Design Ltd, Ocean Optics UK, OncoLytika Ltd, De Montfort University and Nottingham University.