The proposed project aims to develop a novel expression platform for high-level production of monoclonal antibodies (mAbs) with optimized affinity peptide tags for development of advanced antibody drug conjugates (ADCs). The project brings together the expertise from Daresbury Proteins Ltd ("Daresbury"), a UK-based company specializing in novel expression platforms, the National Research Council of Canada ("NRC"), a leading national research agency, and Eurofins CDMO Alphora Inc. ("Alphora"), a global Contract Development and Manufacturing Organization (CDMO) for preclinical and clinical development and manufacturing services. The joint initiative will utilize Daresbury's proprietary modular genetic elements for increased transient and stable expression of mAbs, which will be combined with NRC's transient and stable expression vectors and affinity peptide tag linkers for ADC generation. This innovative approach eliminates the need for extra conjugation and purification steps, reducing the complexity and cost of ADC production and ultimately produces ADCs that can be reconstituted in the clinic, thereby simplifying the production processes. The design will be further optimized by Alphora using various analytical and bioprocess engineering strategies to characterize, conjugate, and scale-up the process for a more comprehensive industrial implementation. In addition to enhancing efficiency of ADC production, work outlined in this collaborative project will improve product quality by generating more homogenous ADC batches (thus improving therapeutic efficacy and potentially reducing undesirable side effects), enhancing controlled release mechanism under specific conditions, lowering immunogenicity due to biocompatibility of peptides over small chemical linkers/molecules, and paving path toward bedside formulation and administration of these targeted drugs. By taking advantage of individual strengths of each partner, we aim to overcome some of the major challenges associated with ADC manufacturing and design a more applicable solution for large-scale biopharmaceutical production.

Lab-grown meat represents a new frontier in Agriculture by which we might sustainably address the needs of a growing global population in an increasingly challenging environment for traditional farming. Yet considerable Manufacturing barriers remain in order for lab-grown meat to hit the price needed to make a meaningful impact upon Food Security and Sustainability. During production, the cells that become meat require culture media, which is a soup of building blocks that feed their growth plus active proteins that provide stimuli that encourage fast growth into the right types of cells, and then into meat tissues. These active proteins in the culture media are the main drivers of high production costs. For the lab-grown meat sector to be economically viable, we must find cheaper sources for these active proteins. In this project Daresbury Proteins and Cofactory will leverage bioinformatics and AI to mine public gene expression datasets to find new ways to boost yields. We will take the most promising mechanisms into the laboratory to demonstrate their practical utility in Growth Factor over-production. This will create new product lines and open up new markets, and secure valuable IP for both companies.

The 21st century ushered the advent of coronaviral pandemics such as SARS in 2002-2004, MERS in 2012-2018 and presently Covid-19\. These infections killed hundreds of thousands of people yet we do not know how to treat or prevent them. Our inability to identify people affected by Covid-19, has led to the spread of the infection on a global scale, causing thousands of deaths on a daily basis. Desperate lockdown measures to stop the pandemic brought many countries and vast geographical regions to a standstill. All these overwhelming effects of Covid-19 could be minimised if not completely prevented by timely and accurate ways to detect the infection. Antigen and antibody detection tests are such methods which can detect the current or past viral infection and are indispensable for the control of Covid-19 spread. However, the development and production of reliable tests require time and the availability of their key components -- viral fragments produced recombinantly. The global scale of pandemic puts a massive strain on the science and industry to supply this key component of diagnostic tests. At the time of writing, there have been 20 SARS-CoV2 antibody kits received Emergency Use Authorisation by Food and Drug Administration, FDA. None of those originated in the UK. Immense pressure on the Government to enable laboratory-based mass serological testing has hastened the adoption of the inferior quality kits sourced from abroad, the performance of which would have been found to be unacceptable in non-pandemic circumstances. Domestic industry can and must turn the tide. Daresbury Proteins will create a sustainable production platform and deploy their technology to manufacture much-needed quality antigens in the shortest timeframe to expedite the production of reliable and affordable Covid-19 testing kits. The availability of such a scalable and cost-effective platform will eliminate any issues with supply chain in the future and warrant a world-leading position of domestic diagnostic industry.